Subjects -> MEDICAL SCIENCES (Total: 8196 journals)
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ENDOCRINOLOGY (149 journals)                     

Showing 1 - 134 of 134 Journals sorted alphabetically
AACE Clinical Case Reports     Hybrid Journal   (Followers: 5)
Acta Diabetologica     Hybrid Journal   (Followers: 17)
Adipositas - Ursachen, Folgeerkrankungen, Therapie     Hybrid Journal   (Followers: 1)
Advances in Chronic Kidney Disease     Hybrid Journal   (Followers: 15)
Advances in Diabetes and Metabolism     Open Access   (Followers: 22)
Advances in Endocrinology     Open Access   (Followers: 7)
AJP Endocrinology and Metabolism     Hybrid Journal   (Followers: 25)
American Journal of Kidney Diseases     Hybrid Journal   (Followers: 53)
Annales d'Endocrinologie     Hybrid Journal   (Followers: 2)
Applied Physiology, Nutrition and Metabolism     Hybrid Journal   (Followers: 36)
Best Practice & Research Clinical Endocrinology & Metabolism     Hybrid Journal   (Followers: 15)
BMC Endocrine Disorders     Open Access   (Followers: 8)
Case Reports in Endocrinology     Open Access   (Followers: 3)
Clinical Diabetes     Full-text available via subscription   (Followers: 40)
Clinical Diabetes and Endocrinology     Open Access   (Followers: 20)
Clinical Endocrinology     Hybrid Journal   (Followers: 42)
Clinical Medicine Insights : Endocrinology and Diabetes     Open Access   (Followers: 29)
Clinical Nutrition Insight     Full-text available via subscription   (Followers: 13)
Clinical Reviews in Bone and Mineral Metabolism     Hybrid Journal  
Comprehensive Psychoneuroendocrinology     Open Access  
Current Opinion in Endocrine and Metabolic Research     Hybrid Journal   (Followers: 2)
Current Opinion in Endocrinology, Diabetes and Obesity     Hybrid Journal   (Followers: 48)
Dermato-Endocrinology     Open Access   (Followers: 2)
Diabesity     Open Access   (Followers: 3)
Diabetes & Metabolic Syndrome: Clinical Research & Reviews     Hybrid Journal   (Followers: 27)
Diabetes & Metabolism     Hybrid Journal   (Followers: 72)
Diabetes, Obesity and Metabolism     Hybrid Journal   (Followers: 250)
Diabetes/Metabolism Research and Reviews     Hybrid Journal   (Followers: 63)
Diabetology & Metabolic Syndrome     Open Access   (Followers: 8)
Discover Oncology     Open Access   (Followers: 1)
Domestic Animal Endocrinology     Hybrid Journal   (Followers: 6)
Dubai Diabetes and Endocrinology Journal     Open Access  
Egyptian Journal of Obesity, Diabetes and Endocrinology     Open Access   (Followers: 1)
Endocrine     Hybrid Journal   (Followers: 11)
Endocrine and Metabolic Science     Open Access   (Followers: 2)
Endocrine Connections     Open Access   (Followers: 4)
Endocrine Disruptors     Open Access  
Endocrine Journal     Open Access   (Followers: 13)
Endocrine Pathology     Hybrid Journal   (Followers: 7)
Endocrine Practice     Hybrid Journal   (Followers: 58)
Endocrine Regulations     Open Access  
Endocrine Research     Hybrid Journal   (Followers: 3)
Endocrine Reviews     Full-text available via subscription   (Followers: 44)
Endocrine, Metabolic & Immune Disorders - Drug Targets     Hybrid Journal   (Followers: 1)
Endocrine-Related Cancer     Full-text available via subscription   (Followers: 2)
Endocrinología, Diabetes y Nutrición (English Edition)     Hybrid Journal   (Followers: 2)
Endocrinology     Full-text available via subscription   (Followers: 50)
Endocrinology and Metabolism Clinics of North America     Full-text available via subscription   (Followers: 28)
Endocrinology, Diabetes & Metabolism     Open Access  
Endocrinology, Diabetes & Metabolism Case Reports     Open Access  
Endocrinology, Obesity and Metabolic Disorders     Full-text available via subscription   (Followers: 6)
Endokrynologia Polska     Open Access   (Followers: 2)
European Journal of Endocrinology     Full-text available via subscription   (Followers: 40)
European Thyroid Journal     Full-text available via subscription   (Followers: 3)
Experimental and Clinical Endocrinology & Diabetes     Hybrid Journal   (Followers: 24)
Experimental and Clinical Endocrinology & Diabetes Reports     Open Access   (Followers: 4)
Expert Opinion on Drug Metabolism & Toxicology     Hybrid Journal   (Followers: 15)
Expert Review of Endocrinology & Metabolism     Hybrid Journal   (Followers: 7)
Frontiers in Clinical Diabetes and Healthcare     Open Access  
Frontiers in Endocrinology     Open Access   (Followers: 5)
Frontiers in Neuroendocrine Science     Open Access  
Frontiers in Neuroendocrinology     Hybrid Journal   (Followers: 10)
General and Comparative Endocrinology     Hybrid Journal   (Followers: 4)
Growth Hormone & IGF Research     Hybrid Journal   (Followers: 14)
Gynakologische Endokrinologie     Hybrid Journal  
Gynecological Endocrinology     Hybrid Journal   (Followers: 5)
Hormone and Metabolic Research     Hybrid Journal   (Followers: 16)
Hormone Research in Paediatrics     Full-text available via subscription   (Followers: 16)
Hormones : International Journal of Endocrinology and Metabolism     Hybrid Journal  
Hormones and Behavior     Hybrid Journal   (Followers: 12)
Indian Journal of Endocrinology and Metabolism     Open Access   (Followers: 4)
International Journal of Clinical Endocrinology and Metabolism     Open Access   (Followers: 1)
International journal of endocrine oncology     Open Access  
International Journal of Endocrinology     Open Access   (Followers: 3)
International Journal of Endocrinology     Open Access   (Followers: 1)
International Journal of Endocrinology and Metabolism     Open Access   (Followers: 3)
International Journal of Obesity     Hybrid Journal   (Followers: 90)
International Journal of Osteoporosis and Metabolic Disorders     Open Access   (Followers: 1)
International Journal of Pediatric Endocrinology     Open Access   (Followers: 11)
JIMD Reports     Open Access  
Journal für Gynäkologische Endokrinologie/Österreich     Hybrid Journal  
Journal für Klinische Endokrinologie und Stoffwechsel : Austrian Journal of Clinical Endocrinology and Metabolism     Hybrid Journal  
Journal of Bone and Mineral Metabolism     Hybrid Journal   (Followers: 5)
Journal of Clinical and Translational Endocrinology     Open Access  
Journal of Clinical and Translational Endocrinology Case Reports     Open Access   (Followers: 2)
Journal of Clinical Endocrinology & Metabolism     Full-text available via subscription   (Followers: 133)
Journal of Developmental Origins of Health and Disease     Hybrid Journal   (Followers: 2)
Journal of Diabetes and Endocrinology     Open Access   (Followers: 7)
Journal of Diabetes and Endocrinology Assocation of Nepal     Open Access  
Journal of Diabetes and Metabolic Disorders     Open Access   (Followers: 8)
Journal of Diabetes Science and Technology     Hybrid Journal   (Followers: 13)
Journal of Diabetology     Open Access   (Followers: 1)
Journal of Endocrinological Investigation     Full-text available via subscription   (Followers: 7)
Journal of Endocrinology     Full-text available via subscription   (Followers: 13)
Journal of Endocrinology and Metabolism     Open Access   (Followers: 5)
Journal of Endocrinology and Reproduction     Hybrid Journal  
Journal of Endocrinology, Metabolism and Diabetes of South Africa     Open Access   (Followers: 8)
Journal of Inborn Errors of Metabolism and Screening     Open Access  
Journal of Molecular Endocrinology     Full-text available via subscription   (Followers: 5)
Journal of Neuroendocrinology     Hybrid Journal   (Followers: 8)
Journal of Pineal Research     Hybrid Journal   (Followers: 1)
Journal of Renal and Hepatic Disorders     Open Access  
Journal of Restorative Medicine     Open Access  
Journal of Social Health and Diabetes     Open Access   (Followers: 1)
Journal of the ASEAN Federation of Endocrine Societies     Open Access  
Kidney International     Hybrid Journal   (Followers: 52)
Kidney Research Journal     Open Access   (Followers: 6)
L'Endocrinologo     Hybrid Journal  
Metabolic Brain Disease     Hybrid Journal   (Followers: 1)
Metabolic Syndrome and Related Disorders     Hybrid Journal   (Followers: 5)
Metabolism     Hybrid Journal   (Followers: 11)
Molecular and Cellular Endocrinology     Hybrid Journal   (Followers: 8)
Molecular Metabolism     Open Access   (Followers: 9)
Nature Reviews Endocrinology     Full-text available via subscription   (Followers: 60)
Neuroendocrinology     Full-text available via subscription   (Followers: 8)
Nigerian Endocrine Practice     Full-text available via subscription  
Nutrition in Clinical Practice     Hybrid Journal   (Followers: 43)
Open Journal of Endocrine and Metabolic Diseases     Open Access   (Followers: 1)
Psychoneuroendocrinology     Hybrid Journal   (Followers: 14)
Reproductive Biology and Endocrinology     Open Access   (Followers: 3)
Reproductive Endocrinology     Open Access   (Followers: 1)
Reviews in Endocrine and Metabolic Disorders     Hybrid Journal   (Followers: 2)
Revista Argentina de Endocrinología y Metabolismo     Open Access  
Revista Cubana de Endocrinología     Open Access  
Revista Venezolana de Endocrinología y Metabolismo     Open Access  
Sri Lanka Journal of Diabetes Endocrinology and Metabolism     Open Access  
The Endocrinologist     Full-text available via subscription   (Followers: 6)
The Lancet Diabetes and Endocrinology     Full-text available via subscription   (Followers: 161)
Therapeutic Advances in Endocrinology and Metabolism     Open Access   (Followers: 5)
Thyroid     Hybrid Journal   (Followers: 11)
Thyroid Research     Open Access   (Followers: 3)
Thyroid Research and Practice     Open Access   (Followers: 3)
Trends in Endocrinology & Metabolism     Full-text available via subscription   (Followers: 19)
Vitamins & Hormones     Full-text available via subscription   (Followers: 1)

           

Similar Journals
Journal Cover
Journal of Diabetes Science and Technology
Journal Prestige (SJR): 1.256
Citation Impact (citeScore): 2
Number of Followers: 13  
 
  Hybrid Journal Hybrid journal (It can contain Open Access articles)
ISSN (Print) 1932-2968
Published by Sage Publications Homepage  [1174 journals]
  • Detection of Meals and Physical Activity Events From Free-Living Data of
           People With Diabetes

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      Authors: Mohammad Reza Askari, Mudassir Rashid, Xiaoyu Sun, Mert Sevil, Andrew Shahidehpour, Keigo Kawaji, Ali Cinar
      Abstract: Journal of Diabetes Science and Technology, Ahead of Print.
      Background:Predicting carbohydrate intake and physical activity in people with diabetes is crucial for improving blood glucose concentration regulation. Patterns of individual behavior can be detected from historical free-living data to predict meal and exercise times. Data collected in free-living may have missing values and forgotten manual entries. While machine learning (ML) can capture meal and exercise times, missing values, noise, and errors in data can reduce the accuracy of ML algorithms.Methods:Two recurrent neural networks (RNNs) are developed with original and imputed data sets to assess detection accuracy of meal and exercise events. Continuous glucose monitoring (CGM) data, insulin infused from pump data, and manual meal and exercise entries from free-living data are used to predict meals, exercise, and their concurrent occurrence. They contain missing values of various lengths in time, noise, and outliers.Results:The accuracy of RNN models range from 89.9% to 95.7% for identifying the state of event (meal, exercise, both, or neither) for various users. “No meal or exercise” state is determined with 94.58% accuracy by using the best RNN (long short-term memory [LSTM] with 1D Convolution). Detection accuracy with this RNN is 98.05% for meals, 93.42% for exercise, and 55.56% for concurrent meal-exercise events.Conclusions:The meal and exercise times detected by the RNN models can be used to warn people for entering meal and exercise information to hybrid closed-loop automated insulin delivery systems. Reliable accuracy for event detection necessitates powerful ML and large data sets. The use of additional sensors and algorithms for detecting these events and their characteristics provides a more accurate alternative.
      Citation: Journal of Diabetes Science and Technology
      PubDate: 2022-06-15T09:48:33Z
      DOI: 10.1177/19322968221102183
       
  • Explainable Machine Learning for Real-Time Hypoglycemia and Hyperglycemia
           Prediction and Personalized Control Recommendations

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      Authors: Christopher Duckworth, Matthew J. Guy, Anitha Kumaran, Aisling Ann O’Kane, Amid Ayobi, Adriane Chapman, Paul Marshall, Michael Boniface
      Abstract: Journal of Diabetes Science and Technology, Ahead of Print.
      Background:The occurrences of acute complications arising from hypoglycemia and hyperglycemia peak as young adults with type 1 diabetes (T1D) take control of their own care. Continuous glucose monitoring (CGM) devices provide real-time glucose readings enabling users to manage their control proactively. Machine learning algorithms can use CGM data to make ahead-of-time risk predictions and provide insight into an individual’s longer term control.Methods:We introduce explainable machine learning to make predictions of hypoglycemia (270 mg/dL) up to 60 minutes ahead of time. We train our models using CGM data from 153 people living with T1D in the CITY (CGM Intervention in Teens and Young Adults With Type 1 Diabetes)survey totaling more than 28 000 days of usage, which we summarize into (short-term, medium-term, and long-term) glucose control features along with demographic information. We use machine learning explanations (SHAP [SHapley Additive exPlanations]) to identify which features have been most important in predicting risk per user.Results:Machine learning models (XGBoost) show excellent performance at predicting hypoglycemia (area under the receiver operating curve [AUROC]: 0.998, average precision: 0.953) and hyperglycemia (AUROC: 0.989, average precision: 0.931) in comparison with a baseline heuristic and logistic regression model.Conclusions:Maximizing model performance for glucose risk prediction and management is crucial to reduce the burden of alarm fatigue on CGM users. Machine learning enables more precise and timely predictions in comparison with baseline models. SHAP helps identify what about a CGM user’s glucose control has led to predictions of risk which can be used to reduce their long-term risk of complications.
      Citation: Journal of Diabetes Science and Technology
      PubDate: 2022-06-13T11:05:10Z
      DOI: 10.1177/19322968221103561
       
  • Comparisons of Fifth-, Sixth-, and Seventh-Generation Continuous Glucose
           Monitoring Systems

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      Authors: John B. Welsh, Simon Psavko, Xiaohe Zhang, Peggy Gao, Andrew K. Balo
      Abstract: Journal of Diabetes Science and Technology, Ahead of Print.
      Background:Between-system differences for continuous glucose monitoring (CGM) devices have important clinical consequences.Purpose:Here we review attributes of Dexcom’s fifth-, sixth-, and seventh-generation (G5, G6, and G7) CGM systems.Methods:Accuracy metrics were derived from preapproval trials of the three systems and compared after propensity score adjustments were used to balance baseline demographic characteristics. Metrics included mean absolute relative differences (MARD) between CGM and YSI values and the proportion of CGM values within 20% or 20 mg/dL of the YSI values (“%20/20”). Ease-of-use was evaluated by formal task analysis.Conclusions:Adjusted MARD and %20/20 agreement rates were 9.0%/93.1% (abdomen-placed G5), 9.9%/92.3% (abdomen-placed G6), 9.1%/93.2% (abdomen-placed G7), and 8.2%/95.3% (arm-placed G7). Task analysis favored G7 over earlier systems. Favorable clinical outcomes such as hemoglobin A1c reduction and hypoglycemia avoidance seen with G5 and G6 are anticipated with G7 use.
      Citation: Journal of Diabetes Science and Technology
      PubDate: 2022-06-13T11:02:18Z
      DOI: 10.1177/19322968221099879
       
  • Evaluation of Effects of Continuous Glucose Monitoring on Physical
           Activity Habits and Blood Lipid Levels in Persons With Type 1 Diabetes
           

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      Authors: Thomas Nyström, Erik Schwarz, Sofia Dahlqvist, Magnus Wijkman, Magnus Ekelund, Helen Holmer, Jan Bolinder, Jarl Hellman, Henrik Imberg, Irl B. Hirsch, Marcus Lind
      Abstract: Journal of Diabetes Science and Technology, Ahead of Print.
      Background:People with type 1 diabetes generally view it easier to exercise when having continuous information of the glucose levels. We evaluated whether patients with type 1 diabetes managed with multiple daily insulin injections (MDI) exercised more after initiating continuous glucose monitoring (CGM) and whether the improved glycemic control and well-being associated with CGM translates into improved blood lipids and markers of inflammation.Method:The GOLD trial was a randomized cross-over trial over 16 months where patients used either CGM or capillary self-monitoring of blood glucose (SMBG) over six months, with a four-month wash-out period between the two treatment periods. We compared grade of physical activity, blood lipids, apolipoproteins, and high-sensitivity C-reactive protein (hsCRP) levels during CGM and SMBG.Results:There were 116 patients with information of physical activity estimated by the International Physical Activity Questionnaire (IPAQ) during both CGM and SMBG. No changes were found during CGM or SMBG, IPAQ scores 3305 versus 3878 (P = .16). In 136 participants with information of blood lipid levels with no change in lipid-lowering medication during the two treatment periods, HbA1c differed by 4.2 mmol/mol (NGSP 0.39%) between SMBG and CGM treatment (P < .001). No significant changes existed in low-density lipoprotein, high-density lipoprotein, triglycerides, total cholesterol, apolipoprotein A1, apolipoprotein B1, or hsCRP, during CGM and SMBG.Conclusion:Although many patients experience it easier to perform physical activity when monitoring glucose levels with CGM, it does not influence the amount of physical activity in persons with type 1 diabetes. Blood lipids, apolipoprotein, and hsCRP levels were similar during CGM and SMBG.
      Citation: Journal of Diabetes Science and Technology
      PubDate: 2022-06-09T06:01:54Z
      DOI: 10.1177/19322968221101916
       
  • Health Disparities Likely Emerge Early in the Course of Type-1 Diabetes in
           Youth

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      Authors: Elise Schlissel Tremblay, Enju Liu, Lori M. Laffel
      Abstract: Journal of Diabetes Science and Technology, Ahead of Print.
      Background:Type-1 diabetes (T1D) management and glycemic control the year after diagnosis affects the long-term trajectory of T1D. Disparities in hemoglobin A1c (HbA1c) based on race, ethnicity, and socioeconomic status (SES) have been well-documented; however, there has been limited investigation into the timeline with which these disparities develop. This study aims to assess differences in HbA1c by race/ethnicity and SES among youth with T1D over 1 year post diagnosis.Methods:HbA1c at onset, and 3, 6, 9, and 12 months following diagnosis was collected from youth with T1D between 2016 and 2020. Mixed-effect models examined associations of HbA1c over time with race/ethnicity and SES.Results:Of 758 patients, 71% identified as white. Mean (± SD) HbA1c was 11.4% ± 2.2% at diagnosis and 7.3% ± 1.2%, 7.3% ± 1.3%, 7.7% ± 1.4%, and 7.9% ± 1.4% at 3, 6, 9, and 12 months, respectively. HbA1c trajectories over time differed significantly by race (adjusting for sex and zip-code education and poverty levels) with Hispanic and black youth demonstrating higher HbA1c 1 year after diagnosis (8.7% vs 7.7%, p < .001) than white youth.Conclusions:These data revealed that youth did not meet glycemic targets at 1 year post diagnosis and that racial/ethnic minority youth had higher HbA1c 1 year post diagnosis, highlighting the need to optimize glycemic control and mitigate disparities early. Understanding the time course of these outcomes helps to inform the need for early interventions, particularly in disadvantaged patient populations, to lay the groundwork for improved control. Further research must also be done to better understand overlapping axes of disparities including race, ethnicity, and SES.
      Citation: Journal of Diabetes Science and Technology
      PubDate: 2022-06-05T07:55:55Z
      DOI: 10.1177/19322968221082646
       
  • Air Bubbles in Insulin Pumps: A Clinically Relevant Issue'

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      Authors: Lutz Heinemann
      Abstract: Journal of Diabetes Science and Technology, Ahead of Print.

      Citation: Journal of Diabetes Science and Technology
      PubDate: 2022-06-04T07:31:32Z
      DOI: 10.1177/19322968221101885
       
  • Personalized Offloading Treatments for Healing Plantar Diabetic Foot
           Ulcers

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      Authors: Gustav Jarl, David F. Rusaw, Alexander J. Terrill, Cleveland T. Barnett, Maria A. Woodruff, Peter A. Lazzarini
      Abstract: Journal of Diabetes Science and Technology, Ahead of Print.
      Background:Non-removable knee-high devices are the gold-standard offloading treatments to heal plantar diabetic foot ulcers (DFUs). These devices are underused in practice for a variety of reasons. Recommending these devices for all patients, regardless of their circumstances and preferences influencing their ability to tolerate the devices, does not seem a fruitful approach.Purpose:The aim of this article is to explore the potential implications of a more personalized approach to offloading DFUs and suggest avenues for future research and development.Methods:Non-removable knee-high devices effectively heal plantar DFUs by reducing plantar pressure and shear at the DFU, reducing weight-bearing activity and enforcing high adherence. We propose that future offloading devices should be developed that aim to optimize these mechanisms according to each individual’s needs. We suggest three different approaches may be developed to achieve such personalized offloading treatment. First, we suggest modular devices, where different mechanical features (rocker-bottom sole, knee-high cast walls/struts, etc.) can be added or removed from the device to accommodate different patients’ needs and the evolving needs of the patient throughout the treatment period. Second, advanced manufacturing techniques and novel materials could be used to personalize the design of their devices, thereby improving common hindrances to their use, such as devices being heavy, bulky, and hot. Third, sensors could be used to provide real-time feedback to patients and clinicians on plantar pressures, shear, weight-bearing activity, and adherence.Conclusions:By the use of these approaches, we could provide patients with personalized devices to optimize plantar tissue stress, thereby improving clinical outcomes.
      Citation: Journal of Diabetes Science and Technology
      PubDate: 2022-06-04T07:20:41Z
      DOI: 10.1177/19322968221101632
       
  • Health Care Professionals’ Perspectives on Use of Diabetes Technologies
           for Managing Visually Impaired Patients With Diabetes

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      Authors: Halis Kaan Akturk, Janet Snell-Bergeon, Viral N. Shah
      Abstract: Journal of Diabetes Science and Technology, Ahead of Print.
      Background:Despite well-established safety and efficacy of diabetes technologies in management of diabetes, their utility in visually impaired patients is currently unknown. We aimed to identify providers’ preferences and challenges to prescribing diabetes technologies for visually impaired patients.Methods:A survey-based study among health care providers in the United States seeing visually impaired patients with diabetes and using diabetes technologies was conducted. The quantitative and qualitative responses were analyzed using Student t test and χ2 tests.Results:Of 79 providers, 66 completed the survey and were included in the analysis. Insulin pens and hybrid closed-loop systems were preferred insulin delivery systems for managing visually impaired patients with diabetes. Despite 96% of the providers recommending continuous glucose monitoring (CGM) for their visually impaired patients with diabetes, only 55% were aware of the voice-activation feature of Dexcom G6. Voice activation to announce glucose values and audible glucose alerts were two major incentives for selecting CGM. System initialization was seen as a prevalent challenge of using CGM in visually impaired patients with diabetes. Providers who are using CGM for visually impaired patients reported benefits for patients using the voice-activation feature for six months included HbA1c reductions of>0.5% (by 87% of providers) and less hypoglycemia (by 45% of providers).Conclusions:The CGM is the preferred glucose monitoring method for managing visually impaired patients with diabetes. Providers face many challenges of initiating CGM in these high-risk patients. Voice-activation feature of G6 CGM is underutilized and providers who used the system reported positive outcomes in visually impaired patients.
      Citation: Journal of Diabetes Science and Technology
      PubDate: 2022-06-04T07:16:23Z
      DOI: 10.1177/19322968221101629
       
  • Neural Networks With Gated Recurrent Units Reduce Glucose Forecasting
           Error due to Changes in Sensor Location

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      Authors: Aaron P. Tucker, Arthur G. Erdman, Pamela J. Schreiner, Sisi Ma, Lisa S. Chow
      Abstract: Journal of Diabetes Science and Technology, Ahead of Print.
      Background:Continuous glucose monitors (CGMs) have become important tools for providing estimates of glucose to patients with diabetes. Recently, neural networks (NNs) have become a common method for forecasting glucose values using data from CGMs. One method of forecasting glucose values is a time-delay feedforward (FF) NN, but a change in the CGM location on a participant can increase forecast error in a FF NN.Methods:In response, we examined a NN with gated recurrent units (GRUs) as a method of reducing forecast error due to changes in sensor location.Results:We observed that for 13 participants with type 2 diabetes wearing blinded CGMs on both arms for 12 weeks (FreeStyle Libre Pro—Abbott), GRU NNs did not produce significantly different errors in glucose prediction due to sensor location changes (P < .05).Conclusion:We observe that GRU NNs can mitigate error in glucose prediction due to differences in CGM location.
      Citation: Journal of Diabetes Science and Technology
      PubDate: 2022-06-04T07:05:50Z
      DOI: 10.1177/19322968221100839
       
  • Trimetazidine Blocks Lipid Oxidation—Should it be Repurposed for
           Prevention and Treatment of Diabetic Ketoacidosis'

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      Authors: David C. Klonoff, Nicole Y. Xu, Kevin T. Nguyen, David Kerr, Chhavi Mehta, Guillermo E. Umpierrez, George A. Brooks
      Abstract: Journal of Diabetes Science and Technology, Ahead of Print.

      Citation: Journal of Diabetes Science and Technology
      PubDate: 2022-06-02T12:47:49Z
      DOI: 10.1177/19322968221100196
       
  • Effect of Diabetes on Tendon Structure and Function: Not Limited to
           Collagen Crosslinking

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      Authors: Rachana Vaidya, Spencer P. Lake, Jennifer A. Zellers
      Abstract: Journal of Diabetes Science and Technology, Ahead of Print.
      Diabetes mellitus (DM) is associated with musculoskeletal complications—including tendon dysfunction and injury. Patients with DM show altered foot and ankle mechanics that have been attributed to tendon dysfunction as well as impaired recovery post-tendon injury. Despite the problem of DM-related tendon complications, treatment guidelines specific to this population of individuals are lacking. DM impairs tendon structure, function, and healing capacity in tendons throughout the body, but the Achilles tendon is of particular concern and most studied in the diabetic foot. At macroscopic levels, asymptomatic, diabetic Achilles tendons may show morphological abnormalities such as thickening, collagen disorganization, and/or calcific changes at the tendon enthesis. At smaller length scales, DM affects collagen sliding and discrete plasticity due to glycation of collagen. However, how these alterations translate to mechanical deficits observed at larger length scales is an area of continued investigation. In addition to dysfunction of the extracellular matrix, tendon cells such as tenocytes and tendon stem/progenitor cells show significant abnormalities in proliferation, apoptosis, and remodeling capacity in the presence of hyperglycemia and advanced glycation end-products, thus contributing to the disruption of tendon homeostasis and healing. Improving our understanding of the effects of DM on tendons—from molecular pathways to patients—will progress toward targeted therapies in this group at high risk of foot and ankle morbidity.
      Citation: Journal of Diabetes Science and Technology
      PubDate: 2022-06-02T01:17:39Z
      DOI: 10.1177/19322968221100842
       
  • HbA1c Variability as an Independent Risk Factor for Microvascular
           Complications in Type 1 Diabetes

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      Authors: Yuanjie Mao, Wenjun Zhong
      Abstract: Journal of Diabetes Science and Technology, Ahead of Print.
      Background:There are few studies on the role of long-term glycemic variability in complications of type 1 diabetes (T1D). This study was aimed to investigate the associations of HbA1c variability represented by the coefficient of variation of HbA1c with incident microvascular complications in T1D by analyzing the data set from the DCCT/EDIC study.Methods:Patients (n = 1240) were divided into four groups by HbA1c variability quartiles. Incident microvascular complications were assessed for a duration of an average of 20.5 years. Multivariable models were performed to examine the associations between HbA1c variability and incident microvascular complications.Results:All incident microvascular complications were higher in the fourth quartile of the HbA1c variability group. After adjusting for clinical risk factors, HbA1c variability was positively associated with a higher risk of all diabetic microvascular complications (P < .05). Specifically, it had 1.125 (1.082-1.170), 1.114 (1.074-1.154), 1.061 (1.024-1.099), or 1.088 (1.052-1.125) times higher odds (95% confidence interval [CI]) of having retinopathy, nephropathy, clinical neuropathy, or autonomic neuropathy, independent of mean HbA1c values (P < .05). Furthermore, there were higher incident microvascular complications with higher HbA1c variability when HbA1c value was above the group median of 7.9%, while only higher incident autonomic neuropathy with higher HbA1c variability when HbA1c was below the group median.Conclusions:Our results showed a significant independent association between HbA1c variability and the risk of microvascular complications in T1D. HbA1c variability might be a supplemental risk stratification tool to mean HbA1c for microvascular complications in T1D.
      Citation: Journal of Diabetes Science and Technology
      PubDate: 2022-06-02T01:12:10Z
      DOI: 10.1177/19322968221100833
       
  • Combined Use of Glucose-Specific Model Identification and Alarm Strategy
           Based on Prediction-Funnel to Improve Online Forecasting of Hypoglycemic
           Events

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      Authors: Simone Faccioli, Francesco Prendin, Andrea Facchinetti, Giovanni Sparacino, Simone Del Favero
      Abstract: Journal of Diabetes Science and Technology, Ahead of Print.
      Background:Advanced decision support systems for type 1 diabetes (T1D) management often embed prediction modules, which allow T1D people to take preventive actions to avoid critical episodes like hypoglycemia. Real-time prediction of blood glucose (BG) concentration relies on a subject-specific model of glucose-insulin dynamics. Model parameter identification is usually based on the mean square error (MSE) cost function, and the model is usually used to predict BG at a single prediction horizon (PH). Finally, a hypo-alarm is raised if the predicted BG crosses a threshold. This work aims to show that real-time hypoglycemia forecasting can be improved by leveraging: a glucose-specific mean square error (gMSE) cost function in model’s parameters identification, and a “prediction-funnel,” that is, confidence intervals (CIs) for multiple PHs, within the hypo-alarm-raising strategy.Methods:Autoregressive integrated moving average with exogenous input (ARIMAX) models are selected to illustrate the proposed solution (use of gMSE and prediction-funnel) and its assessment against the conventional approach (MSE and single PH). The gMSE penalizes the model misfit in unsafe BG ranges (e.g., hypoglycemia), and the prediction-funnel allows raising an alarm by monitoring if the CIs cross a suitable threshold. The algorithms were evaluated by measuring precision (P), recall (R), F1-score (F1), false positive per day (FP/day), and time gain (TG) on a real dataset collected in 11 T1D individuals.Results:The best performance is achieved exploiting both the gMSE and the prediction-funnel: P = 65%, R = 88%, F1 = 75%, FP/day = 0.29, and mean TG = 15 minutes.Conclusions:The combined use of a glucose-specific metric and an alarm-raising strategy based on the prediction-funnel allows achieving a more effective and reliable hypoglycemia prediction algorithm.
      Citation: Journal of Diabetes Science and Technology
      PubDate: 2022-05-25T06:27:21Z
      DOI: 10.1177/19322968221093665
       
  • Predicting Response to Bolus Insulin Therapy in Patients With Type 2
           Diabetes

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      Authors: Elizabeth L. Eby, Neal R. Kelly, Jeffrey K. Hertzberg, Moira C. Blodgett, Callie Stubbins, Raja H. Patel, Eric S Meadows, Brian D. Benneyworth, Douglas E. Faries
      Abstract: Journal of Diabetes Science and Technology, Ahead of Print.
      Background:The aim of this study was to develop a predictive model to classify people with type 2 diabetes (T2D) into expected levels of success upon bolus insulin initiation.Methods:Machine learning methods were applied to a large nationally representative insurance claims database from the United States (dNHI database; data from 2007 to 2017). We trained boosted decision tree ensembles (XGBoost) to assign people into Class 0 (never meeting HbA1c goal), Class 1 (meeting but not maintaining HbA1c goal), or Class 2 (meeting and maintaining HbA1c goal) based on the demographic and clinical data available prior to initiating bolus insulin. The primary objective of the study was to develop a model capable of determining at an individual level, whether people with T2D are likely to achieve and maintain HbA1c goals. HbA1c goal was defined at 1.0%.Results:Of 15 331 people with T2D (mean age, 53.0 years; SD, 8.7), 7800 (50.9%) people met HbA1c goal but failed to maintain that goal (Class 1), 4510 (29.4%) never attained this goal (Class 0), and 3021 (19.7%) people met and maintained this goal (Class 2). Overall, the model’s receiver operating characteristic (ROC) was 0.79 with greater performance on predicting those in Class 2 (ROC = 0.92) than those in Classes 0 and 1 (ROC = 0.71 and 0.62, respectively). The model achieved high area under the precision-recall curves for the individual classes (Class 0, 0.46; Class 1, 0.58; Class 2, 0.71).Conclusions:Predictive modeling using routine health care data reasonably accurately classified patients initiating bolus insulin who would achieve and maintain HbA1c goals, but less so for differentiation between patients who never met and who did not maintain goals. Prior HbA1c was a major contributing parameter for the predictions.
      Citation: Journal of Diabetes Science and Technology
      PubDate: 2022-05-21T06:27:14Z
      DOI: 10.1177/19322968221098057
       
  • Accuracy Evaluation of a Novel Reusable Patch Pump Prototype

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      Authors: Jochen Mende, Annette Baumstark, Delia Waldenmaier, Amin Amirouche, Antoine Barraud, Pierre Fridez, Cornelia Haug, Guido Freckmann
      Abstract: Journal of Diabetes Science and Technology, Ahead of Print.
      A prototype of an insulin patch pump that operates with a double pump mechanism was tested. Accuracy of bolus delivery of 0.2 U and 1.0 U, and a basal rate of 1.0 U/h were evaluated with a microgravimetric method. In addition, occlusion detection time at basal rates of 0.1 U/h and 1.0 U/h was assessed. Mean deviation from target was lower than 2% for both bolus sizes. Regarding basal rate accuracy, mean deviation over 72 hours was lower than 1%. Occlusion detection occurred in less than 30 minutes with both basal rates. Our study results suggest that the tested pump prototype provides delivery accuracy and occlusion detection that is similar or even better compared to all commercially available pumps tested with a similar experimental approach.
      Citation: Journal of Diabetes Science and Technology
      PubDate: 2022-05-21T06:20:56Z
      DOI: 10.1177/19322968221097997
       
  • Distribution of Oxygen Partial Pressures in Native Capillary Fingertip
           Blood Samples From a Large Diabetes Patient Population

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      Authors: Steven Setford, Stuart Phillips, Hilary Cameron, Mike Grady
      Abstract: Journal of Diabetes Science and Technology, Ahead of Print.
      A data set comprising 28 533 oxygen partial pressure (pO2) values gathered from nonarterialized fingertip capillary blood samples of a large diabetes population is reported. Data were gathered routinely as part of the ongoing clinical surveillance activities of a blood glucose monitoring (BGM) system manufacturer. Overall, a mean pO2 level of 75.3 mm Hg was recorded, with a standard deviation (SD) of 10.6 mm Hg and a range of 27.7 to 151.5 mm Hg. This data set, unique in terms of size, gathered more than 14 years at four separate clinical sites, provides a robust and comprehensive representation of an unmanipulated pO2 fingertip capillary sample distribution, which should be of interest for physiological reasons, but also from a medical device development perspective, in which the effect of pO2 on device performance may be an important design consideration.
      Citation: Journal of Diabetes Science and Technology
      PubDate: 2022-05-19T10:16:11Z
      DOI: 10.1177/19322968221095055
       
  • Laboratory Protocol and Pilot Results for Dynamic Interference Testing of
           Continuous Glucose Monitoring Sensors

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      Authors: Andreas Pfützner, Hendrick Jensch, Christopher Cardinal, Geetham Srikanthamoorthy, Eric Riehn, Nicole Thomé
      Abstract: Journal of Diabetes Science and Technology, Ahead of Print.
      Background:Testing the potential influence of interfering substances on the measurement performance of needle sensors for continuous glucose monitoring (CGM) is a challenging task. For proper function, the sensors need an almost stable fluidic environment. Previously published in vitro interference experiments were measuring under static concentration conditons. Our experimental setup allows for interference testing with dynamic changes of the interferent concentrations.Methods:We designed a macrofluidic test stand that is fueled by several high-pressure liquid chromatography (HPLC) pumps generating programmable glucose and/or interferent gradients in phosphate-buffered saline (PBS). After optimizing experimental parameters (channel dimensions, temperature, flow rates, gradient slopes, buffer, pH etc.), we validated the setup using Dexcom G6 (G6) and Freestyle Libre 2 (L2) sensors with/without interferents, and using YSI 2300 Stat plus as the reference glucose device at room temperature.Results:Both sensors tracked the programmed glucose changes. After calibration, G6 results closely matched glucose reference readings, while L2 routinely showed ~50% to 60% lower readings, most likely because of the factory-based calibration and temperature compensation. Gradients of maltose, acetaminophen, and xylose were employed to further validate the setup. As expected, both sensors were not affected by maltose. We confirmed previous findings regarding susceptibility of G6 readings to acetaminophen and L2 readings to xylose. Signals from both sensors are influenced by temperature in a linear fashion.Conclusions:Our experimental in vitro setup and protocol may provide a useful method to dynamically test CGM sensors for interfering substances. This may help to improve the accuracy of future CGM sensor generations.
      Citation: Journal of Diabetes Science and Technology
      PubDate: 2022-05-13T11:59:39Z
      DOI: 10.1177/19322968221095573
       
  • Patterns and Predictors Associated With Long-Term Glycemic Control in
           Pediatric and Young Adult Patients with Type 1 Diabetes

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      Authors: Johan Jendle, Björn Agvall, Alexander Galozy, Peter Adolfsson
      Abstract: Journal of Diabetes Science and Technology, Ahead of Print.
      Background:The development of diabetes technology is rapid and requires education and resources to be successfully implemented in diabetes care management.Method:In an observational study, we evaluated the use of advanced diabetes technology, resource utilization, and glycemic control. The study population was 725 individuals with type 1 diabetes (T1D) living in Region Halland, Sweden. The study cohort was followed for 7 years between 2013 and 2019.Results:Children aged 0 to 17 years were associated with significantly better glucose control than young adults aged 18 to 25 years. The mean HbA1c in children and young adults was 53 mmol/mol (7.0%) compared to 61 mmol/mol (7.7%) (P < .0001), respectively. Comorbidities such as attention deficit hyperactivity disorder (ADHD), autism, and coelic disease were associated with higher HbA1c. All groups, regardless of age and comorbidity, showed a positive effect on glucose control after visiting a dietitian or psychologist. Differences were found between the age groups in terms of more use of advanced diabetes technology and more frequent visits to a physician in children compared to young adults.Conclusions:More frequent visits to physicians, and a visit to dietitians, and psychologists were associated with improved glucose control in individuals with T1D 0 to 25 years. Increased resources, including access to more advanced technologies, may be required in young adults with T1D.
      Citation: Journal of Diabetes Science and Technology
      PubDate: 2022-05-13T06:42:30Z
      DOI: 10.1177/19322968221096423
       
  • First Outpatient Clinical Trial of a Full Closed-Loop Artificial Pancreas
           System in South America

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      Authors: Fabricio Garelli, Emilia Fushimi, Nicolás Rosales, Delfina Arambarri, Leandro Mendoza, María Cecilia Serafini, Marcela Moscoso-Vásquez, Marianela Stasi, Patricia Duette, Julia García-Arabehety, Javier Nicolás Giunta, Hernán De Battista, Ricardo Sánchez-Peña, Luis Grosembacher
      Abstract: Journal of Diabetes Science and Technology, Ahead of Print.
      Background:The first two studies of an artificial pancreas (AP) system carried out in Latin America took place in 2016 (phase 1) and 2017 (phase 2). They evaluated a hybrid algorithm from the University of Virginia (UVA) and the automatic regulation of glucose (ARG) algorithm in an inpatient setting using an AP platform developed by the UVA. The ARG algorithm does not require carbohydrate (CHO) counting and does not deliver meal priming insulin boluses. Here, the first outpatient trial of the ARG algorithm using an own AP platform and doubling the duration of previous phases is presented.Method:Phase 3 involved the evaluation of the ARG algorithm in five adult participants (n = 5) during 72 hours of closed-loop (CL) and 72 hours of open-loop (OL) control in an outpatient setting. This trial was performed with an own AP and remote monitoring platform developed from open-source resources, called InsuMate. The meals tested ranged its CHO content from 38 to 120 g and included challenging meals like pasta. Also, the participants performed mild exercise (3-5 km walks) daily. The clinical trial is registered in ClinicalTrials.gov with identifier: NCT04793165.Results:The ARG algorithm showed an improvement in the time in hyperglycemia (52.2% [16.3%] OL vs 48.0% [15.4%] CL), time in range (46.9% [15.6%] OL vs 50.9% [14.4%] CL), and mean glucose (188.9 [25.5] mg/dl OL vs 186.2 [24.7] mg/dl CL) compared with the OL therapy. No severe hyperglycemia or hypoglycemia episodes occurred during the trial. The InsuMate platform achieved an average of more than 95% of the time in CL.Conclusion:The results obtained demonstrated the feasibility of outpatient full CL regulation of glucose levels involving the ARG algorithm and the InsuMate platform.
      Citation: Journal of Diabetes Science and Technology
      PubDate: 2022-05-13T06:38:49Z
      DOI: 10.1177/19322968221096162
       
  • Can A Basic Management App Paired With A Glucose Meter Help Reduce Glucose
           Levels Among Adults With Type 2 Diabetes' The REALL Study

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      Authors: Lawrence Fisher, Addie Fortmann, Jennifer Knaebel, Andreas Stuhr
      Abstract: Journal of Diabetes Science and Technology, Ahead of Print.
      Objective:Evaluations of technology to help adults manage type 2 diabetes (T2D) have yielded mixed results. We analyzed the effectiveness of a free app linked to a glucose meter to study reductions in glucose levels over time among a self-selected sample of adults with T2D.Research Design and Methods:Adults with T2D>12 months,>21 years, ability to read English (insulin using—IU and non-insulin using—NIU) who independently elected to pair their CONTOUR NEXT ONE meter with the CONTOUR DIABETES App were invited to participate. Glucose data from baseline to 16 weeks were uploaded to the cloud (N = 461). Assessment of diabetes distress, medication taking, quality of life, and hypoglycemia concerns occurred at baseline, six, and 16 weeks.Results:Findings indicated a significant decrease in weekly glucose levels over time: baseline mean = 169 (62.0) (9.4 mmol/L; 3.44); 16-week mean = 146.5 (36.0) (8.1 mmol/L; 2.0) (P < .001), with no IU and NIU differences. Largest reductions occurred during the first six weeks, with no later rebound effects. Significant, though modest, improvements in global quality of life (P = .03), hypoglycemia concerns (P = .01), and diabetes distress (P < .001) occurred over 16 weeks.Conclusions:Making an App for monitoring glucose easily available for download with a glucose meter can be helpful for self-selected adults with T2D. Effective utilization assumes that users are sufficiently motivated and engaged, are comfortable and trusting of the technology, and have sufficient knowledge of how to make use of the glucose data.
      Citation: Journal of Diabetes Science and Technology
      PubDate: 2022-05-09T05:29:58Z
      DOI: 10.1177/19322968221096163
       
  • People With Diabetes and Caregivers Prefer Rescue Glucagon Treatment With
           a Wider Storage Temperature Range and a Nasal Administration, When
           Efficacy is Similar: A Discrete Choice Experiment in Spain

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      Authors: Beth D. Mitchell, Anne M. Rentz, Shannon Kummer, Yu Yan, Sebastian Heidenreich, Nicolas Krucien, Esther Artime, Beatrice Osumili, Miriam Rubio, Heather L. Gelhorn
      Abstract: Journal of Diabetes Science and Technology, Ahead of Print.
      Background:Conventional injectable glucagon (IG) and nasal glucagon (NG), both having similar efficacy, are two options for the emergency treatment of severe hypoglycemia in Spain. This study elicited the effect of changes in key attributes on preferences for NG and IG medication profiles of people with diabetes and caregivers in Spain.Methods:The relative attribute importance (RAI) that participants placed on glucagon preparation, preparation and administration time, delivery method, recovery time, device size, storage temperature, and headache risk was estimated from an online discrete choice experiment. In addition, patients and caregivers were presented with NG and IG profiles that included rates of successful administration; the proportion of participants choosing each profile was summarized.Results:The analysis included 276 adults with diabetes (65% type 1) and 270 caregivers (49% type 1). Overall mean age was 40 years; 51% were female. The most important attributes were storage temperature (RAI [95% confidence interval] = 27.3% [22.9-32.2]) and delivery method (17.4% [13.1-21.9]). Headache risk (16.2% [11.8-20.7]), time to prepare and administer (14.5% [10.1-18.8]), glucagon preparation (11.4% [6.8-15.8]), recovery time (8.9% [4.3-13.3]), and device size (4.3% [0.3-8.8]) were also relevant. When comparing medication profiles, significantly more participants (78%) preferred NG over IG profiles (P < .001).Conclusion:Adults with diabetes and caregivers prefer a glucagon treatment with a higher rate of successful administration, wider storage temperature, and nasal delivery method, when efficacy is similar. Participants favored NG over conventional IG as a rescue medication for severe hypoglycemia. This information may help decision-making by payers and treatment discussions between health care professionals and patients.
      Citation: Journal of Diabetes Science and Technology
      PubDate: 2022-05-09T05:24:17Z
      DOI: 10.1177/19322968221095882
       
  • The Influence of Real-Time Continuous Glucose Monitoring on Psychosocial
           Outcomes in Insulin-Using Type 2 Diabetes

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      Authors: Emily C. Soriano, William H. Polonsky
      Abstract: Journal of Diabetes Science and Technology, Ahead of Print.
      Background:To examine the impact of real-time continuous glucose monitoring (rtCGM) on psychosocial outcomes in adults with insulin-using type 2 diabetes (T2D).Methods:A total of 174 insulin-using adults with T2D completed questionnaires assessing diabetes distress, hypoglycemic confidence, hypoglycemic fear, device-related emotional burden, and device-related trust before and after a six-month trial of rtCGM. Hemoglobin A1c (HbA1c) was assessed at the same time points; impaired hypoglycemic awareness (IAH) was assessed at baseline. Change in psychosocial outcomes was examined with t tests, then modeled as a function of baseline HbA1c and IAH and simultaneous change in HbA1c in multiple regression analyses.Results:Respondents were predominantly male (57.5%) and non-Hispanic white (67.8%). Significant improvement over the trial was observed in hypoglycemic fear (P = .031), hypoglycemic confidence (P < .001), diabetes distress (P < .001), and device-related emotional burden (P < .001). Impaired hypoglycemic awareness at baseline predicted greater improvement in hypoglycemic fear (P = .002), hypoglycemic confidence (P = .003), diabetes distress (P = .013), and device-related emotional burden (P < .001). Higher baseline HbA1c was linked with greater improvement in hypoglycemic fear (P = .030); HbA1c change over the trial was positively associated with change in diabetes distress (P = .010) and device-related emotional burden (P = .003).Conclusions:Introduction of rtCGM in adults with insulin-using T2D was associated with significant improvements in diabetes-related psychosocial outcomes over six months. Gains were significantly greater among participants reporting IAH and those with higher HbA1c at baseline, thus providing the first evidence regarding which users might more likely benefit.
      Citation: Journal of Diabetes Science and Technology
      PubDate: 2022-05-09T05:20:37Z
      DOI: 10.1177/19322968221094831
       
  • Effectiveness of Telemedicine in Managing Diabetes in Pregnancy: A
           Systematic Review and Meta-Analysis

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      Authors: Sisse H. Laursen, Lise Boel, Flemming W. Udsen, Pernille H. Secher, Jonas D. Andersen, Peter Vestergaard, Ole K. Hejlesen, Stine Hangaard
      Abstract: Journal of Diabetes Science and Technology, Ahead of Print.
      Background:Strict monitoring of blood glucose during pregnancy is essential for ensuring optimal maternal and neonatal outcomes. Telemedicine could be a promising solution for supporting diabetes management; however, an updated meta-analysis is warranted. This study assesses the effects of telemedicine solutions for managing gestational and pregestational diabetes.Methods:PubMed, EMBASE, Cochrane Library Central Register of Controlled Trials, and CINAHL were searched up to October 14, 2020. All randomized trials assessing the effects of telemedicine in managing diabetes in pregnancy relative to any comparator without the use of telemedicine were included. The primary outcome was infant birth weight. A meta-analysis comparing the mean difference (MD) in birth weight across studies was applied, and subgroup and sensitivity analyses were performed. The revised Cochrane tool was applied to assess the risk of bias, and the certainty of evidence was evaluated using the Grading of Recommendations, Assessment, Development, and Evaluation (GRADE) approach.Results:From a total of 18 studies, ten (totaling 899 participants) were used to calculate the effect on infant birth weight. The results nonsignificantly favored the control (MD of 19.34 g; [95% confidence interval, CI −47.8; 86.47]), with moderate effect certainty. Heterogeneity was moderate (I2 = 37.39%). Statistically significant secondary outcomes included differences in two-hour glucose tolerance postpartum (gestational diabetes; two studies: standardized mean difference 9.62 mg/dL [95% CI: 1.95; 17.28]) that favored the control (GRADE level, very low) and risk of shoulder dystocia (four studies: log odds −1.34 [95% CI: −2.61; −0.08]) that favored telemedicine (GRADE, low).Conclusions:No evidence was found to support telemedicine as an alternative to usual care when considering maternal and fetal outcomes. However, further research is needed, including economic evaluations.
      Citation: Journal of Diabetes Science and Technology
      PubDate: 2022-05-09T05:18:57Z
      DOI: 10.1177/19322968221094626
       
  • The Launch of the iCoDE Standard Project

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      Authors: Nicole Y. Xu, Kevin T. Nguyen, Ashley Y. DuBord, David C. Klonoff, Julian M. Goldman, Shahid N. Shah, Elias K. Spanakis, Charisse Madlock-Brown, Siavash Sarlati, Azhar Rafiq, Axel Wirth, David Kerr, Raman Khanna, Scott Weinstein, Juan Espinoza
      Abstract: Journal of Diabetes Science and Technology, Ahead of Print.
      Introduction:The first meeting of the Integration of Continuous Glucose Monitor Data into the Electronic Health Record (iCoDE) project, organized by Diabetes Technology Society, took place virtually on January 27, 2022.Methods:Clinicians, government officials, data aggregators, attorneys, and standards experts spoke in panels and breakout groups. Three themes were covered: 1) why digital health data integration into the electronic health record (EHR) is needed, 2) what integrated continuously monitored glucose data will look like, and 3) how this process can be achieved in a way that will satisfy clinicians, healthcare organizations, and regulatory experts.Results:The meeting themes were addressed within eight sessions: 1) What Do Inpatient Clinicians Want to See With Integration of CGM Data into the EHR', 2) What Do Outpatient Clinicians Want to See With Integration of CGM Data into the EHR', 3) Why Are Data Standards and Guidances Useful', 4) What Value Can Data Integration Services Add', 5) What Are Examples of Successful Integration', 6) Which Privacy, Security, and Regulatory Issues Must Be Addressed to Integrate CGM Data into the EHR', 7) Breakout Group Discussions, and 8) Presentation of Breakout Group Ideas.Conclusions:Creation of data standards and workflow guidance are necessary components of the Integration of Continuous Glucose Monitor Data into the Electronic Health Record (iCoDE) standard project. This meeting, which launched iCoDE, will be followed by a set of working group meetings intended to create the needed standard.
      Citation: Journal of Diabetes Science and Technology
      PubDate: 2022-05-09T05:15:16Z
      DOI: 10.1177/19322968221093662
       
  • In Vivo Study of the Inflammatory Tissue Response Surrounding a Novel
           Extended-Wear Kink-Resistant Insulin Infusion Set Prototype Compared With
           a Commercial Control Over Two Weeks of Wear Time

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      Authors: Jasmin R. Kastner, Gabriella Eisler, Marc C. Torjman, Abdurizzagh Khalf, David Diaz, Alek R. Dinesen, Channy Loeum, Paul J. Strasma, Jeffrey I Joseph
      Abstract: Journal of Diabetes Science and Technology, Ahead of Print.
      Background:Infusion set function remains the limiting factor of insulin pump therapy due to nonmetabolic complications. Here, we tested an investigational extended-wear infusion set prototype with a soft, angled, wire-reinforced cannula with three additional side holes, and compared failure mechanisms and tissue response with a commercial Teflon control.Methods:A total of 48 Teflon and 48 prototype infusion sets were inserted subcutaneously every other day for 14 days in 12 swine and infused with dilute insulin. After two weeks, tissue around cannulas was excised, and occlusions, leaks, and kinks were determined. Tissue was processed and stained to assess the total area of inflammation (TAI) and the inflammatory layer thickness (ILT) around the cannulas. Data were analyzed using Fisher’s exact, analysis of variance-general linear model, Kruskal-Wallis, and post hoc tests.Results:On average, the TAI surrounding the investigational cannula was 52.6% smaller than around the commercial control. The ILT was 66.3% smaller around investigational cannulas. Kinks occurred in 2.1% (investigational) vs 32.4% (commercial) cannulas (P 
      Citation: Journal of Diabetes Science and Technology
      PubDate: 2022-05-09T05:12:37Z
      DOI: 10.1177/19322968221093362
       
  • No Result: A Neglected Glucose Meter Metric

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      Authors: Jan S. Krouwer
      Abstract: Journal of Diabetes Science and Technology, Ahead of Print.

      Citation: Journal of Diabetes Science and Technology
      PubDate: 2022-05-07T01:42:06Z
      DOI: 10.1177/19322968221094329
       
  • Guideline Development for Medical Device Technology: Issues for
           Consideration

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      Authors: Tadej Battelino, Frank Brosius, Antonio Ceriello, Francesco Cosentino, Jennifer Green, Monika Kellerer, Susan Koob, Mikhail Kosiborod, Nebojsa Lalic, Nikolaus Marx, T. Prashant Nedungadi, Lars Rydén, Helena W. Rodbard, Linong Ji, Wayne Huey-Herng Sheu, Eberhard Standl, Christopher G. Parkin, Oliver Schnell
      Abstract: Journal of Diabetes Science and Technology, Ahead of Print.
      Advances in the development of innovative medical devices and telehealth technologies create the potential to improve the quality and efficiency of diabetes care through collecting, aggregating, and interpreting relevant health data in ways that facilitate more informed decisions among all stakeholder groups. Although many medical societies publish guidelines for utilizing these technologies in clinical practice, we believe that the methodologies used for the selection and grading of the evidence should be revised. In this article, we discuss the strengths and limitations of the various types of research commonly used for evidence selection and grading and present recommendations for modifying the process to more effectively address the rapid pace of device and technology innovation and new product development.
      Citation: Journal of Diabetes Science and Technology
      PubDate: 2022-05-07T01:40:57Z
      DOI: 10.1177/19322968221093355
       
  • A New Digital Point-of-Care Tool With Advanced Blood Glucose Measuring
           Technology

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      Authors: Simon Gessler, Ulrich Porsch, David C. Klonoff, Michael Marquant
      Abstract: Journal of Diabetes Science and Technology, Ahead of Print.
      cobas® pulse is a point-of-care blood glucose (BG) measuring system for multiple-patient use in professional healthcare settings. The system provides advances in connectivity and BG measuring technology, and has multiple fail-safes to improve accuracy and reduce the risk of user error. Flavin adenine dinucleotide-dependent glucose dehydrogenase on the working electrode catalyzes oxidation of β-D-glucose in the blood sample. A redox mediator/electron acceptor, on both the working and the counter electrode, facilitates diffusion of electrons in proportion to the glucose concentration and compensates for the effects of potential interfering agents. During development,>1 million test strip measurements were performed using>8000 test scenarios to refine the algorithm model. No clinically relevant interference was identified with extreme variations in blood properties and drugs in whole blood samples.
      Citation: Journal of Diabetes Science and Technology
      PubDate: 2022-05-05T09:43:42Z
      DOI: 10.1177/19322968221092763
       
  • Evaluating Factors Associated With Continuous Glucose Monitoring
           Utilization With the Type 1 Diabetes Exchange Registry

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      Authors: Richard Bailey, Sriya Donthi, Sarah Markt, Colin Drummond, Jennifer Cullen
      Abstract: Journal of Diabetes Science and Technology, Ahead of Print.
      Background:The 2022 American Diabetes Association (ADA) Standards of Care recommends considering use of continuous glucose monitoring (CGM) for insulin-managed diabetes mellitus (DM), but equitable access remains challenging. This study evaluates socioeconomic and demographic metrics associated with CGM use.Methods:RStudio 2021.09.1+372 was utilized to perform uni- and bivariable analysis, as well as binomial logistic regression modeling for categorical CGM use (yes/no) on the most recent cross-section from the Type 1 Diabetes Exchange (T1DX) Registry 2016-2018 cohort (n = 22 418).Results:Compared with White Non-Hispanic participants, Black Non-Hispanic (OR = 0.45, CI = 0.36-0.57, P < 0.001) and American Indian/Alaskan Native individuals (OR = 0.33, CI = 0.14-0.70, P = 0.008) had lower odds of CGM use. Compared with private insurance, government insurance had reduced odds of CGM use (OR = 0.59, CI = 0.52-0.66, P < 0.001). Individuals earning $100,000 or more were twice as likely to use CGMs (OR = 2.06, CI = 1.75-2.45, P < 0.001) compared with those earning
      Citation: Journal of Diabetes Science and Technology
      PubDate: 2022-05-04T06:49:15Z
      DOI: 10.1177/19322968221091299
       
  • Diabetes Technology Meeting 2021

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      Authors: Nicole Y. Xu, Kevin T. Nguyen, Ashley Y. DuBord, John Pickup, Jennifer L. Sherr, Hazhir Teymourian, Eda Cengiz, Barry H. Ginsberg, Claudio Cobelli, David Ahn, Riccardo Bellazzi, B. Wayne Bequette, Laura Gandrud Pickett, Linda Parks, Elias K. Spanakis, Umesh Masharani, Halis K. Akturk, John S. Melish, Sarah Kim, Gu Eon Kang, David C. Klonoff
      Abstract: Journal of Diabetes Science and Technology, Ahead of Print.
      Diabetes Technology Society hosted its annual Diabetes Technology Meeting on November 4 to November 6, 2021. This meeting brought together speakers to discuss various developments within the field of diabetes technology. Meeting topics included blood glucose monitoring, continuous glucose monitoring, novel sensors, direct-to-consumer telehealth, metrics for glycemia, software for diabetes, regulation of diabetes technology, diabetes data science, artificial pancreas, novel insulins, insulin delivery, skin trauma, metabesity, precision diabetes, diversity in diabetes technology, use of diabetes technology in pregnancy, and green diabetes. A live demonstration on a mobile app to monitor diabetic foot wounds was presented.
      Citation: Journal of Diabetes Science and Technology
      PubDate: 2022-05-02T10:51:58Z
      DOI: 10.1177/19322968221090279
       
  • A Smartphone-Based Application to Assist Insulin Titration in Patients
           Undergoing Basal Insulin-Supported Oral Antidiabetic Treatment

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      Authors: Dietrich Tews, Evanthia Gouveri, Jörg Simon, Cornelia Marck
      Abstract: Journal of Diabetes Science and Technology, Ahead of Print.
      Introduction:INSULIA is an insulin-titration app developed for patients with type 2 diabetes treated with basal insulin as part of a basal insulin-supported oral therapy (BOT). The app uses patient-logged fasting blood glucose (FBG) values and a titration plan defined by the treating physician to provide basal insulin dosing recommendations. Physicians use the web portal to monitor their patients’ therapy progress and, if necessary, adjust therapy. The aim of this study was to assess the app, specifically its features, handling and impact on diabetes treatment and self-management in Germany.Methods:This German retrospective pilot study included physicians (diabetologists, general practitioners, and internists) and patients with type 2 diabetes who either receive or start BOT using the app. Both groups completed group-specific questionnaires between December 2018 and June 2019.Results:Overall, 10 physicians and 34 patients with type 2 diabetes completed their respective questionnaires. Physicians perceived their app-using patients to be more involved and more confident in managing their insulin therapy than patients not using the app. The majority of patients considered the app as a tool that assists with safer insulin treatment. The physicians perceived that due to the app use, FBG and HbA1c target values were achieved more often than patients not using the app and the number and severity of hypoglycemic episodes was reduced.Conclusion:The titration app seems to have a positive impact on BOT patients’ FBG and HbA1c target achievement and was highly appreciated by both physicians and patients alike.
      Citation: Journal of Diabetes Science and Technology
      PubDate: 2022-04-30T03:10:40Z
      DOI: 10.1177/19322968221090521
       
  • Telehealth Technologies in Diabetes Self-management and Education

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      Authors: Vidya Sharma, Marie Feldman, Ramaswamy Sharma
      Abstract: Journal of Diabetes Science and Technology, Ahead of Print.
      Background:The coronavirus pandemic of 2019 (COVID-19) forced worldwide recognition and implementation of telehealth as a means of providing continuity of care by varied health care institutions. Diabetes is a global health threat with rates that continue to accelerate, thereby causing an increased need for clinicians to provide diabetes care and education to keep up with demand. Utilizing technology to provide education via phone/smartphone, video/audio, web, text message, mobile apps, or a combination of these methods can help improve patient access and clinical outcomes, cut costs, and close gaps in care.Methods:While numerous publications have summarized the various tools and technologies available for capturing remote clinical data and their relevance to diabetes care and self-management, this review focuses on self-educational telehealth tools available for diabetes self-management, their advantages and disadvantages, and factors that need to be considered prior to implementation. Recent relevant studies indexed by PubMed were included.Results:The widespread use and popularity of phones/smartphones, tablets, computers, and the Internet by patients of all age groups, cultures, socioeconomic and geographic areas allow for increased outreach, flexibility, and engagement with diabetes education, either in combination or as an adjunct to traditional in-person visits. Demonstrated benefits of using health technologies for diabetes self-management education include improved lifestyle habits, reduced hemoglobin A1C levels, decreased health care costs, and better medication adherence. Potential drawbacks include lack of regulation, need for staff training on methodologies used, the requirement for patients to be tech savvy, privacy concerns, lag time with technology updates/glitches, and the need for more long-term research data on efficacy.Conclusions:Telehealth technologies for diabetes self-education improve overall clinical outcomes and have come a long way. With increasing numbers of patients with diabetes, it is expected that more optimal and user-friendly methodologies will be developed to fully engage and help patients communicate with their physicians.
      Citation: Journal of Diabetes Science and Technology
      PubDate: 2022-04-29T12:22:56Z
      DOI: 10.1177/19322968221093078
       
  • Outcomes in Pump- and CGM-Baseline Use Subgroups in the International
           Diabetes Closed-Loop (iDCL) Trial

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      Authors: Laya Ekhlaspour, Dan Raghinaru, Gregory P. Forlenza, Elvira Isganaitis, Yogish C. Kudva, David W. Lam, Camilla Levister, Grenye O’Malley, Mei Mei Church, John W. Lum, Bruce Buckingham, Sue A. Brown
      Abstract: Journal of Diabetes Science and Technology, Ahead of Print.
      Background:We investigated the potential benefits of automated insulin delivery (AID) among individuals with type 1 diabetes (T1D) in sub-populations of baseline device use determined by continuous glucose monitor (CGM) use status and insulin delivery via multiple daily injections (MDI) or insulin pump.Materials and Methods:In a six-month randomized, multicenter trial, 168 individuals were assigned to closed-loop control (CLC, Control-IQ, Tandem Diabetes Care), or sensor-augmented pump (SAP) therapy. The trial included a two- to eight-week run-in phase to train participants on study devices. The participants were stratified into four subgroups: insulin pump and CGM (pump+CGM), pump-only, MDI and CGM (MDI+CGM), and MDI users without CGM (MDI-only) users. We compared glycemic outcomes among four subgroups.Results:At baseline, 61% were pump+CGM users, 18% pump-only users, 10% MDI+CGM users, and 11% MDI-only users. Mean time in range 70-180 mg/dL (TIR) improved from baseline in the four subgroups using CLC: pump+CGM, 62% to 73%; pump-only, 61% to 70%; MDI+CGM, 54% to 68%; and MDI-only, 61% to 69%. The reduction in time below 70 mg/dL from baseline was comparable among the four subgroups. No interaction effect was detected with baseline device use for TIR (P = .67) or time below (P = .77). On the System Usability Questionnaire, scores were high at 26 weeks for all subgroups: pump+CGM: 87.2 ± 12.1, pump-only: 89.4 ± 8.2, MDI+CGM 87.2 ± 9.3, MDI: 78.1 ± 15.Conclusions:There was a consistent benefit in patients with T1D when using CLC, regardless of baseline insulin delivery modality or CGM use. These data suggest that this CLC system can be considered across a wide range of patients.
      Citation: Journal of Diabetes Science and Technology
      PubDate: 2022-04-27T06:37:29Z
      DOI: 10.1177/19322968221089361
       
  • Expert Recommendations for Using Time-in-Range and Other Continuous
           Glucose Monitoring Metrics to Achieve Patient-Centered Glycemic Control in
           People With Diabetes

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      Authors: Virginia Bellido, Eva Aguilera, Roque Cardona-Hernandez, Gonzalo Diaz-Soto, Noemi González Pérez de Villar, María J. Picón-César, Francisco Javier Ampudia-Blasco
      Abstract: Journal of Diabetes Science and Technology, Ahead of Print.
      New metrics for assessing glycemic control beyond HbA1c have recently emerged due to the increasing use of continuous glucose monitoring (CGM) in diabetes clinical practice. Among them, time in range (TIR) has appeared as a simple and intuitive metric that correlates inversely with HbA1c and has also been newly linked to the risk of long-term diabetes complications. The International Consensus on Time in Range established a series of target glucose ranges (TIR, time below range and time above range) and recommendations for time spent within these ranges for different diabetes populations. These parameters should be evaluated together with the ambulatory glucose profile (AGP). Using standardized visual reporting may help people with diabetes and healthcare professionals in the evaluation of glucose control in frequent clinical situations. The objective of the present review is to provide practical insights to quick interpretation of patient-centered metrics based on flash glucose monitoring data, as well as showing some visual examples of common clinical situations and giving practical recommendations for their management.
      Citation: Journal of Diabetes Science and Technology
      PubDate: 2022-04-26T11:10:42Z
      DOI: 10.1177/19322968221088601
       
  • Long-term Prediction of Blood Glucose Levels in Type 1 Diabetes Using a
           CNN-LSTM-Based Deep Neural Network

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      Authors: Mehrad Jaloli, Marzia Cescon
      Abstract: Journal of Diabetes Science and Technology, Ahead of Print.
      Background:In this work, we leverage state-of-the-art deep learning–based algorithms for blood glucose (BG) forecasting in people with type 1 diabetes.Methods:We propose stacks of convolutional neural network and long short-term memory units to predict BG level for 30-, 60-, and 90-minute prediction horizon (PH), given historical glucose measurements, meal information, and insulin intakes. The evaluation was performed on two data sets, Replace-BG and DIAdvisor, representative of free-living conditions and in-hospital setting, respectively.Results:For 90-minute PH, our model obtained mean absolute error of 17.30 ± 2.07 and 18.23 ± 2.97 mg/dL, root mean square error of 23.45 ± 3.18 and 25.12 ± 4.65 mg/dL, coefficient of determination of 84.13 ± 4.22% and 82.34 ± 4.54%, and in terms of the continuous glucose-error grid analysis 94.71 ± 3.89% and 91.71 ± 4.32% accurate predictions, 1.81 ± 1.06% and 2.51 ± 0.86% benign errors, and 3.47 ± 1.12% and 5.78 ± 1.72% erroneous predictions, for Replace-BG and DIAdvisor data sets, respectively.Conclusion:Our investigation demonstrated that our method achieved superior glucose forecasting compared with existing approaches in the literature, and thanks to its generalizability showed potential for real-life applications.
      Citation: Journal of Diabetes Science and Technology
      PubDate: 2022-04-25T11:24:38Z
      DOI: 10.1177/19322968221092785
       
  • Patch Pumps: Periodic Insulin Delivery Patterns

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      Authors: Manuel Eichenlaub, Ralph Ziegler, Lutz Heinemann, Delia Waldenmaier, Ulrike Kamecke, Cornelia Haug, Guido Freckmann
      Abstract: Journal of Diabetes Science and Technology, Ahead of Print.
      Recent in vitro experiments with patch pumps (PP) Omnipod (OP), Omnipod DASH (OP-D), A6 TouchCare (A6), and Accu-Chek Solo (ACS) have observed periodic fluctuations in the delivered amount of insulin during basal rate and consecutive bolus delivery in some PP, calling for a more systematic characterization of these periodic delivery patterns. Here, it was found that during basal rate delivery of 1 U/h, some devices of OP, OP-D, and A6 showed deviations of up to ±30% from target delivery that consistently repeated every 5 hours, whereas ACS showed no clear periodicity with considerably lower deviations. Similar results were found during consecutive bolus delivery of 1 U, where deviations repeated consistently every five boluses in some devices of OP, OP-D, and A6. However, there was a large variability in the periodic delivery patterns between individual devices of the same PP model. Examining their pumping techniques indicated a connection between the insulin delivery mechanism and observed delivery patterns of the PP. However, the clinical impact of such patterns is unclear.
      Citation: Journal of Diabetes Science and Technology
      PubDate: 2022-04-25T11:22:30Z
      DOI: 10.1177/19322968221091843
       
  • Accuracy of a Seventh-Generation Continuous Glucose Monitoring System in
           Children and Adolescents With Type 1 Diabetes

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      Authors: Lori M. Laffel, Timothy S. Bailey, Mark P. Christiansen, Jennifer L. Reid, Stayce E. Beck
      Abstract: Journal of Diabetes Science and Technology, Ahead of Print.
      Background:Accuracy of a seventh-generation “G7” continuous glucose monitoring (CGM) system was evaluated in children and adolescents with type 1 diabetes (T1D).Methods:Sensors were worn on the upper arm and abdomen. The CGM data were available from 127 of 132 participants, ages 7 to 17 years, across 10.5 days of use, various glucose concentration ranges, and various rates of glucose change for comparisons with temporally matched venous blood glucose measurements (YSI). Data were also available from 28 of 32 participants, ages 2 to 6 years, for whom capillary (fingerstick) blood provided comparator glucose values. Accuracy metrics included the mean absolute relative difference (MARD) between CGM and comparator glucose pairs, the proportion of CGM values within 15 mg/dL or 15% of comparator values
      Citation: Journal of Diabetes Science and Technology
      PubDate: 2022-04-25T11:20:57Z
      DOI: 10.1177/19322968221091816
       
  • Spanish Consensus on the Use of isCGM in the Management of Patients With
           Insulin Therapy: The MONITOR Project

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      Authors: Francisco Javier Ampudia-Blasco, Estibaliz Ugarte-Abasolo, Ana Chico, Jorge García-Alemán, Manuel Galan-Barroso
      Abstract: Journal of Diabetes Science and Technology, Ahead of Print.
      Background:Continuous glucose monitoring (CGM) systems are increasingly being adopted as an alternative or adjunct to self-monitoring of blood glucose (SMBG) by patients receiving insulin therapy. However, the available evidence on the role of intermittently scanned CGM or flash CGM (isCGM) remains limited. This consensus aims to evaluate the degree of agreement among Spanish experts on the role of isCGM in the evaluation of glycemic variability, reduction of glycosylated hemoglobin (HbA1c) levels, and selection and adjustment of insulin therapy.Methods:Delphi methodology was used to achieve consensus in two survey rounds. A total of 431 Spanish endocrinologists participated in the first round of a 34-item questionnaire survey on isCGM and 427 participated in the second round. Any disagreement was resolved in round 2.Results:Consensus was reached for 32 statements, and four items were ultimately agreed upon SMBG after round 2. There was a high degree of consensus that isCGM helps to evaluate glycemic variability, improves HbA1c levels, and can guide therapeutic changes in type 1 diabetes patients. However, there was no consensus on the routine use of the interquartile range to evaluate glycemic variability or the selection of HbA1c as the main parameter for monitoring glycemic control.Conclusions:Most Spanish experts believe that the isCGM system is appropriate for: (1) identifying glycemic variability and facilitating its management, (2) evaluating hyperglycemia as a complement of HbA1c levels, and (3) guiding therapeutic decisions on insulin selection and dosing. The isCGM system is a useful tool for patients and health care professionals to improve glycemic control in insulin-dependent diabetes.
      Citation: Journal of Diabetes Science and Technology
      PubDate: 2022-04-25T11:20:10Z
      DOI: 10.1177/19322968221087270
       
  • In Vitro Continuous 3 Months Operation of Direct Electron Transfer Type
           Open Circuit Potential Based Glucose Sensor: Heralding the Next CGM
           Sensor~

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      Authors: Inyoung Lee, Tsugawa Wakako, Kazunori Ikebukuro, Koji Sode
      Abstract: Journal of Diabetes Science and Technology, Ahead of Print.
      Background:While continuous glucose monitoring (CGM) systems allow precise and real-time blood glucose control, current electrochemicalbased CGM technologies inherently harbor enzyme instability issues. The direct electron transfer (DET) type open circuit potential (OCP) based enzyme sensing principle can minimize the catalytic turnover of the enzyme reaction, thereby providing longer-term operational stability in future CGM glucose sensors.Method:DET-type OCP based glucose sensors were constructed using gold disk electrodes with glucose dehydrogenase capable of DET which was immobilized using a self-assembled monolayer (SAM). The single enzyme layer prepared on the gold electrode was operated in the presence of glucose, using in vitro buffer solution, continuously for over 3 months with the OCP sensor signal monitored every 10 seconds at 25°C.Results:The DET-type OCP glucose sensor was continuously operated for more than 3 months without a significant decrease of the sensor signal and sensitivity (slope). These results suggest that the DET-type OCP glucose sensor is far more stable than the sensor constructed based on the amperometric principle. The long-term stability of DET-type OCP glucose sensor is attributed to the enzyme’s minimized catalytic reaction during the operation, thereby extending the lifetime of enzyme.Conclusion:The DET-type OCP glucose sensor can be continuously operated for more than 3 months at 25 °C, in vitro without significant decreases in sensor signal and sensitivity. While the further investigation will be required for in vivo validation, the DET-type OCP glucose sensor is ideal for next generation CGM’s, especially in long duration implantable use cases.
      Citation: Journal of Diabetes Science and Technology
      PubDate: 2022-04-25T09:22:30Z
      DOI: 10.1177/19322968221092449
       
  • Discordance Between Glycated Hemoglobin A1c and the Glucose Management
           Indicator in People With Diabetes and Chronic Kidney Disease

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      Authors: Philippe Oriot, Claire Viry, Antoine Vandelaer, Sébastien Grigioni, Malanie Roy, Jean Christophe Philips, Gaëtan Prévost
      Abstract: Journal of Diabetes Science and Technology, Ahead of Print.
      Introduction:Assessment of glucose exposure via glycated hemoglobin A1c (HbA1c) has limitations for interpretation in individuals with diabetes and chronic kidney disease (CKD). The glucose management indicator (GMI) derived from continuous glucose monitoring (CGM) data could be an alternative. However, the concordance between HbA1c measured in laboratory and GMI (HbA1c-GMI) is uncertain in individuals with CKD. The purpose of this study is to analyze this discrepancy.Material and method:We performed a multicentric, retrospective, observational study. A group of individuals with diabetes and CKD (n = 170) was compared with a group of individuals with diabetes without CKD (n = 185). All individuals used an intermittently scanned continuous glucose monitoring (isCGM). A comparison of 14-day and 90-day glucose data recorded by the isCGM was performed to calculate GMI and the discordance between lab HbA1c and GMI was analyzed by a Bland-Altman method and linear regression.Results:HbA1c-GMI discordance was significantly higher in the CKD group versus without CKD group (0.78 ± 0.57 [0.66-0.90] vs 0.59 ± 0.44 [0.50-0.66]%, P < .005). An absolute difference>0.5% was found in 68.2% of individuals with CKD versus 42.2% of individuals without CKD. We suggest a new specific formula to estimate HbA1c from the linear regression between HbA1c and mean glucose CGM, namely CKD-GMI = 0.0261 × 90-day mean glucose (mg/L) + 3.5579 (r2 = 0.59).Conclusions:HbA1c-GMI discordance is frequent and usually in favor of an HbA1c level higher than the GMI value, which can lead to errors in changes in glucose-lowering therapy, especially for individuals with CKD. This latter population should benefit from the CGM to measure their glucose exposure more precisely.
      Citation: Journal of Diabetes Science and Technology
      PubDate: 2022-04-25T09:18:10Z
      DOI: 10.1177/19322968221092050
       
  • Analysis of “Glycemic Outcomes During Real-World Hybrid Closed-Loop
           System Use by Individuals With Type 1 Diabetes in the United States”

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      Authors: Johan Jendle
      Abstract: Journal of Diabetes Science and Technology, Ahead of Print.
      In an article in the Journal of Diabetes Science and Technology, Arunachalum et al retrospectively analyzed glycemic outcomes, regarding the use of hybrid closed-loop (HCL) systems in individuals with type-1 diabetes (T1D) in the United States in a real-world evidence (RWE) setting. In clinical trials, diabetes technology has shown to improve time in range (TIR) as well as other glucose metrics. In the light of increasing the use of diabetes technology in the T1D population, why do we not see improvement in clinical outcomes' Is it cost-effective to increase the use diabetes technology' Does access to diabetes technology vary in the United States' There is a need for additional clinical studies evaluating the effectiveness of diabetes technology in T1D including health economic aspects.
      Citation: Journal of Diabetes Science and Technology
      PubDate: 2022-04-25T09:14:59Z
      DOI: 10.1177/19322968221091842
       
  • Strengths and Challenges of Closed-Loop Insulin Delivery During Exercise
           in People With Type 1 Diabetes: Potential Future Directions

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      Authors: Barbora Paldus, Dale Morrison, Melissa Lee, Dessi P. Zaharieva, Michael C. Riddell, David N. O’Neal
      Abstract: Journal of Diabetes Science and Technology, Ahead of Print.
      Exercise has many physical and psychological benefits and is recommended for people with type 1 diabetes; however, there are many barriers to exercise, including glycemic instability and fear of hypoglycemia. Closed-loop (CL) systems have shown benefit in the overall glycemic management of type 1 diabetes, including improving HbA1c levels and reducing the incidence of nocturnal hypoglycemia; however, these systems are challenged by the rapidly changing insulin needs with exercise. This commentary focuses on the principles, strengths, and challenges of CL in the management of exercise, and discusses potential approaches, including the use of additional physiological signals, to address their shortcomings in the pursuit of fully automated CL systems.
      Citation: Journal of Diabetes Science and Technology
      PubDate: 2022-04-25T06:43:05Z
      DOI: 10.1177/19322968221088327
       
  • Glycemic Outcomes During Real-World Hybrid Closed-Loop System Use by
           Individuals With Type 1 Diabetes in the United States

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      Authors: Siddharth Arunachalum, Kevin Velado, Robert A. Vigersky, Toni L. Cordero
      Abstract: Journal of Diabetes Science and Technology, Ahead of Print.
      Background:Glycemic outcomes during real-world hybrid closed-loop (HCL) system use by individuals with type 1 diabetes, in the United States, were retrospectively analyzed.Methods:Hybrid closed-loop system data voluntarily uploaded to Carelink™ personal software from March 2017 to November 2020 by individuals (aged ≥7 years) using the MiniMed™ 670G system and having ≥10 days of continuous glucose monitoring data after initiating Auto Mode were assessed. Glycemic outcomes including the mean glucose management indicator (GMI), sensor glucose (SG), percentage of time spent in (TIR), below (TBR), and above (TAR) target range (70-180 mg/dL) were analyzed. Outcomes were also analyzed in a subgroup of users per baseline GMI of 8%.Results:The overall cohort (N = 123 355 users, with a mean of 87.9% of time in Auto Mode) had a GMI of 7.0% ± 0.4%, TIR of 70.4% ± 11.2%, TBR 180 mg/dL of 27.5% ± 11.6%, post-Auto Mode initiation. Compared with pre-Auto Mode initiation, users (N = 52 941, 88.6% of time in Auto Mode) had a GMI that decreased from 7.3% ± 0.6% to 7.1% ± 0.5% (P < .001), TIR that increased from 61.5% ± 15.1% to 68.1% ± 11.9% (P < .001), TAR>180 mg/dL that decreased from 36.3% ± 15.7% to 29.8% ± 12.2% (P < .001) and TBR8.0% group, the baseline GMI 180 mg/dL that increased (19.2 ± 6.7 to 19.6 ± 7.9%, p < 0.001).Conclusion:Real-world HCL system use in the U.S. demonstrated overall glycemic control that trended similarly with the system pivotal trial outcomes and previous real-world system use analyses.
      Citation: Journal of Diabetes Science and Technology
      PubDate: 2022-04-13T06:36:25Z
      DOI: 10.1177/19322968221088608
       
  • Diabetes Specialists Value CGM Despite Challenges in Prescribing and Data
           Review Process

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      Authors: Tejaswi Kompala, Jenise Wong, Aaron Neinstein
      Abstract: Journal of Diabetes Science and Technology, Ahead of Print.
      Background:Diabetes clinicians are key facilitators of continuous glucose monitoring (CGM) provision, but data on provider behavior related to CGM use and CGM generated data are limited.Methods:We conducted a national survey of providers caring for people with diabetes on CGM-related opinions, facilitators and barriers to prescription, and data review practices.Results:Of 182 survey respondents, 73.2% worked at academic centers, 70.6% were endocrinologists, and 70.7% practiced in urban settings. Nearly 70% of providers reported CGM use in the majority of their patients with type 1 diabetes. Half of the providers reported CGM use in 10% to 50% of their patients with type 2 diabetes. All respondents believed CGM improved quality of life and could optimize diabetes control. We found no differences in reported rates of CGM use based on providers’ years of experience, patient volume, practice setting, or clinic type. Most providers reviewed CGM data each visit (97.7%) and actively involved patients in the data interpretation (98.8%). Only 14.1% of clinicians reported reviewing CGM data without any prompting from patients or their family members outside of visits. Most providers (80.7%) reported their CGM data review was valued by patients although only half reported having adequate time (45.1%) or an efficient process (56.1%) to do so.Conclusions:Despite uniform support for CGM by providers, ongoing challenges related to cost, insurance coverage, and difficulties with prescription were major barriers to CGM use. Increased use of CGM in appropriate populations will necessitate improvements in data access and integration, clearly defined workflows, and decreased administrative burden to obtain CGM.
      Citation: Journal of Diabetes Science and Technology
      PubDate: 2022-04-11T09:33:03Z
      DOI: 10.1177/19322968221088267
       
  • Design of the DAVOS Study: Diabetes Smartphone App, a Fully Automatic
           Transmission of Data From the Blood Glucose Meter and Insulin Pens Using
           Wireless Technology to Enhance Diabetes Self-Management—A Study Protocol
           for a Randomized Controlled Trial

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      Authors: Franziska Grosser, Sandra Herrmann, Maxi Bretschneider, Patrick Timpel, Janko Schildt, Markus Bentrup, Peter E. H. Schwarz
      Abstract: Journal of Diabetes Science and Technology, Ahead of Print.
      Background:In the treatment of diabetes mellitus, the challenge is to integrate adequate self-management into clinical care. Customization including goal setting, monitoring, and feedback could be achieved through digitization. Digital linking between different devices could simplify and promote self-management. The aim of this study is to evaluate the outcome of diabetes treatment assisted by a digital health application compared with standard diabetes therapy.Methods:The DAVOS study is a 6-month-period prospective, multicentric, randomized controlled trial. In total, 154 diabetes patients (age ≥18; treated with insulin) will be recruited and randomized into control group or intervention group. Both groups will receive standard diabetes care. The intervention group will additionally use a diabetes app. HbA1c value will be monitored on three separate defined visits. Primary endpoint is the overall reduction of HbA1c value. Secondary endpoints (eg, usability of the app) will be determined through patient-reported outcome questionnaires.Discussion:Through enhanced interaction of health care professionals, providers of the app, and patients, the study aims to demonstrate improvement in the self-management of diabetes. As part of the closure management, all patients will be invited to use the examined application after completion of the study. The DAVOS study will be conducted in accordance with the valid version of the present study protocol and the internationally recognized International Conference on Harmonization–Good Clinical Practice (ICH-GCP) Guidelines. Special attention will be paid to European, national, and regional requirements for the approval, provision, and use of medical devices. The study was registered in the German Register of Clinical Trials (DRKS) with number DRKS00025996.
      Citation: Journal of Diabetes Science and Technology
      PubDate: 2022-04-08T09:28:51Z
      DOI: 10.1177/19322968221075333
       
  • Designing Take-Back for Single Use Medical Devices: The Case of ReturpenTM

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      Authors: Pravin Kumar Mallick, Kim Bang Salling, Daniela C. A. Pigosso, Tim C. McAloone
      Abstract: Journal of Diabetes Science and Technology, Ahead of Print.
      Focus on take-back of waste products is currently enjoying increased importance, as attention on environmental sustainability and circular economy grows. Single-Use or Disposable Medical Devices (SUDs), which in homecare settings often end up in landfills or incineration, are currently subject to attention, regarding the potential to slow the flow of waste and seek new value creation possibilities. Via a descriptive single-case study of the “ReturpenTM” initiative—a collaborative take-back initiative launched in three municipalities in Denmark—characteristics are elicited, of the planning, launch, and implementation, of the first 6-month pilot of the ReturpenTM initiative. ReturpenTM is a collaborative partnership of 15 public and private organizations and is adopting an end-to-end approach for its development and execution, including numerous professional workstreams. The pilot of the ReturpenTM achieved participation of 66 of the existing 73 pharmacies in 3 municipalities (90% participation rate), and an overall return rate of 13% for the used insulin pens, despite the limitations caused by the covid-19 pandemic. The return rates ranged from 10% to 15% in the 3 municipalities, and overall, the second quarter recovery (15%) was higher than the first quarter (11%). ReturpenTM demonstrates how a workstream-based approach can provide a practical framework for the development and implementation of SUD take-back in a homecare setting. The case describes how the pharmaceutical industry is taking proactive measures to contribute to a more circular economy for disposable medical devices, including the infrastructure and ecosystem necessary to ensure a closed-loop system for medical devices.
      Citation: Journal of Diabetes Science and Technology
      PubDate: 2022-04-08T07:12:19Z
      DOI: 10.1177/19322968221088329
       
  • Insulin Titration Guidelines for Patients With Type 1 Diabetes: It Is
           About Time!

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      Authors: John Walsh, Ruth Roberts, Timothy S. Bailey, Lutz Heinemann
      Abstract: Journal of Diabetes Science and Technology, Ahead of Print.
      Purpose:A proposal that an Insulin Advisory Committee develop insulin titration guidelines 100 years after its discovery.Findings:Glucose control metrics remain poor despite significant advances in diabetes technology.Summary:A century after the introduction of insulin, health care providers and patients with type 1 diabetes have worldwide access to a variety of insulin delivery devices (IDDs), glucose monitors, bolus calculators (BCs), continuous glucose monitors (CGMs), and automated insulin delivery (AID) systems. However, these advances have not enabled most patients to achieve today’s clear A1c and time-in-range goals. Much of this failure arises from the lack of clear insulin titration guidelines for determining appropriate insulin doses. The lack of dosing clarity results in local physicians, clinics, and individual patients managing insulin titrations as they see fit, creating significant inefficiencies for reaching recommended glycemic goals. This review (1) details the widespread problems generated by nonphysiological dose settings in today’s BCs, insulin pumps, and AID systems; (2) presents a method to develop and implement optimized total daily doses of insulin to correct the most common problem of hyperglycemia; (3) discusses using large device databases to provide clear insulin titration guidelines that optimize BC settings from an optimized total daily dose (TDD) of insulin for patients with T1D; and (4) recommends the formation of an Insulin Advisory Committee to clarify the steps to take toward universal insulin titration guidelines, optimized BC settings, and a systematic logic for their use in insulin delivery devices.
      Citation: Journal of Diabetes Science and Technology
      PubDate: 2022-04-02T11:07:46Z
      DOI: 10.1177/19322968221087261
       
  • A Glycemia Risk Index (GRI) of Hypoglycemia and Hyperglycemia for
           Continuous Glucose Monitoring Validated by Clinician Ratings

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      Authors: David C. Klonoff, Jing Wang, David Rodbard, Michael A. Kohn, Chengdong Li, Dorian Liepmann, David Kerr, David Ahn, Anne L. Peters, Guillermo E. Umpierrez, Jane Jeffrie Seley, Nicole Y. Xu, Kevin T. Nguyen, Gregg Simonson, Michael S. D. Agus, Mohammed E. Al-Sofiani, Gustavo Armaiz-Pena, Timothy S. Bailey, Ananda Basu, Tadej Battelino, Sewagegn Yeshiwas Bekele, Pierre-Yves Benhamou, B. Wayne Bequette, Thomas Blevins, Marc D. Breton, Jessica R. Castle, James Geoffrey Chase, Kong Y. Chen, Pratik Choudhary, Mark A. Clements, Kelly L. Close, Curtiss B. Cook, Thomas Danne, Francis J. Doyle, Angela Drincic, Kathleen M. Dungan, Steven V. Edelman, Niels Ejskjaer, Juan C. Espinoza, G. Alexander Fleming, Gregory P. Forlenza, Guido Freckmann, Rodolfo J. Galindo, Ana Maria Gomez, Hanna A. Gutow, Lutz Heinemann, Irl B. Hirsch, Thanh D. Hoang, Roman Hovorka, Johan H. Jendle, Linong Ji, Shashank R. Joshi, Michael Joubert, Suneil K. Koliwad, Rayhan A. Lal, M. Cecilia Lansang, Wei-An (Andy) Lee, Lalantha Leelarathna, Lawrence A. Leiter, Marcus Lind, Michelle L. Litchman, Julia K. Mader, Katherine M. Mahoney, Boris Mankovsky, Umesh Masharani, Nestoras N. Mathioudakis, Alexander Mayorov, Jordan Messler, Joshua D. Miller, Viswanathan Mohan, James H. Nichols, Kirsten Nørgaard, David N. O’Neal, Francisco J. Pasquel, Athena Philis-Tsimikas, Thomas Pieber, Moshe Phillip, William H. Polonsky, Rodica Pop-Busui, Gerry Rayman, Eun-Jung Rhee, Steven J. Russell, Viral N. Shah, Jennifer L. Sherr, Koji Sode, Elias K. Spanakis, Deborah J. Wake, Kayo Waki, Amisha Wallia, Melissa E. Weinberg, Howard Wolpert, Eugene E. Wright, Mihail Zilbermint, Boris Kovatchev
      Abstract: Journal of Diabetes Science and Technology, Ahead of Print.
      Background:A composite metric for the quality of glycemia from continuous glucose monitor (CGM) tracings could be useful for assisting with basic clinical interpretation of CGM data.Methods:We assembled a data set of 14-day CGM tracings from 225 insulin-treated adults with diabetes. Using a balanced incomplete block design, 330 clinicians who were highly experienced with CGM analysis and interpretation ranked the CGM tracings from best to worst quality of glycemia. We used principal component analysis and multiple regressions to develop a model to predict the clinician ranking based on seven standard metrics in an Ambulatory Glucose Profile: very low–glucose and low-glucose hypoglycemia; very high–glucose and high-glucose hyperglycemia; time in range; mean glucose; and coefficient of variation.Results:The analysis showed that clinician rankings depend on two components, one related to hypoglycemia that gives more weight to very low-glucose than to low-glucose and the other related to hyperglycemia that likewise gives greater weight to very high-glucose than to high-glucose. These two components should be calculated and displayed separately, but they can also be combined into a single Glycemia Risk Index (GRI) that corresponds closely to the clinician rankings of the overall quality of glycemia (r = 0.95). The GRI can be displayed graphically on a GRI Grid with the hypoglycemia component on the horizontal axis and the hyperglycemia component on the vertical axis. Diagonal lines divide the graph into five zones (quintiles) corresponding to the best (0th to 20th percentile) to worst (81st to 100th percentile) overall quality of glycemia. The GRI Grid enables users to track sequential changes within an individual over time and compare groups of individuals.Conclusion:The GRI is a single-number summary of the quality of glycemia. Its hypoglycemia and hyperglycemia components provide actionable scores and a graphical display (the GRI Grid) that can be used by clinicians and researchers to determine the glycemic effects of prescribed and investigational treatments.
      Citation: Journal of Diabetes Science and Technology
      PubDate: 2022-03-29T03:00:01Z
      DOI: 10.1177/19322968221085273
       
  • Multimedia Data-Based Mobile Applications for Dietary Assessment

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      Authors: Maria F. Vasiloglou, Isabel Marcano, Sergio Lizama, Ioannis Papathanail, Elias K. Spanakis, Stavroula Mougiakakou
      Abstract: Journal of Diabetes Science and Technology, Ahead of Print.
      Diabetes mellitus (DM) and obesity are chronic medical conditions associated with significant morbidity and mortality. Accurate macronutrient and energy estimation could be beneficial in attempts to manage DM and obesity, leading to improved glycemic control and weight reduction, respectively. Existing dietary assessment methods are subject to major errors in measurement, are time consuming, are costly, and do not provide real-time feedback. The increasing adoption of smartphones and artificial intelligence, along with the advances in algorithms and hardware, allowed the development of technologies executed in smartphones that use food/beverage multimedia data as an input, and output information about the nutrient content in almost real time. Scope of this review was to explore the various image-based and video-based systems designed for dietary assessment. We identified 22 different systems and divided these into three categories on the basis of their setting for evaluation: laboratory (12), preclinical (7), and clinical (3). The major findings of the review are that there is still a number of open research questions and technical challenges to be addressed and end users—including health care professionals and patients—need to be involved in the design and development of such innovative solutions. Last, there is a clear need that these systems should be validated under unconstrained real-life conditions and that they should be compared with conventional methods for dietary assessment.
      Citation: Journal of Diabetes Science and Technology
      PubDate: 2022-03-29T01:09:39Z
      DOI: 10.1177/19322968221085026
       
  • Determining Losses in Jet Injection Subcutaneous Insulin Delivery: A
           Model-Based Approach

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      Authors: Alexander D. McHugh, J. Geoffrey Chase, Jennifer L. Knopp, Tony Zhou, Lui Holder-Pearson
      Abstract: Journal of Diabetes Science and Technology, Ahead of Print.
      Objective:Accurate, safe glycemic management requires reliable delivery of insulin doses. Insulin can be delivered subcutaneously for action over a longer period of time. Needle-free jet injectors provide subcutaneous (SC) delivery without requiring needle use, but the volume of insulin absorbed varies due to losses associated with the delivery method. This study employs model-based methods to determine the expected proportion of active insulin present from a needle-free SC dose.Methods:Insulin, C-peptide, and glucose assay data from a frequently sampled insulin-modified oral glucose tolerance test trial with 2U SC insulin delivery, paired with a well-validated metabolic model, predict metabolic outcomes for N = 7 healthy adults. Subject-specific nonlinear hepatic clearance profiles are modeled over time using third-order basis splines with knots located at assay times. Hepatic clearance profiles are constrained within a physiological rate of change, and relative to plasma glucose profiles. Insulin loss proportions yielding optimal insulin predictions are then identified, quantifying delivery losses.Results:Optimal parameter identification suggests losses of up to 22% of the nominal 2U SC dose. The degree of loss varies between subjects and between trials on the same subject. Insulin fit accuracy improves where loss greater than 5% is identified, relative to where delivery loss is not modeled.Conclusions:Modeling shows needle-free SC jet injection of a nominal dose of insulin does not necessarily provide metabolic action equivalent to total dose, and this availability significantly varies between trials. By quantifying and accounting for variability of jet injection insulin doses, better glycemic management outcomes using SC jet injection may be achieved.
      Citation: Journal of Diabetes Science and Technology
      PubDate: 2022-03-26T09:05:10Z
      DOI: 10.1177/19322968221085032
       
  • Long-term Continuous Glucose Monitor Use in Very Young Children With Type
           1 Diabetes: One-Year Results From the SENCE Study

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      Authors: Michelle A. Van Name, Lauren G. Kanapka, Linda A. DiMeglio, Kellee M. Miller, Anastasia Albanese-O’Neill, Persis Commissariat, Sarah D. Corathers, Kara R. Harrington, Marisa E. Hilliard, Barbara J. Anderson, Jennifer C. Kelley, Lori M. Laffel, Sarah A. MacLeish, Brandon M. Nathan, William V. Tamborlane, R. Paul Wadwa, Steven M. Willi, Kristen M. Williams, Kupper A. Wintergerst, Stephanie Woerner, Jenise C. Wong, Daniel J. DeSalvo
      Abstract: Journal of Diabetes Science and Technology, Ahead of Print.
      Objectives:Achieving optimal glycemic outcomes in young children with type 1 diabetes (T1D) is challenging. This study examined the durability of continuous glucose monitoring (CGM) coupled with a family behavioral intervention (FBI) to improve glycemia.Study Design:This one-year study included an initial 26-week randomized controlled trial of CGM with FBI (CGM+FBI) and CGM alone (Standard-CGM) compared with blood glucose monitoring (BGM), followed by a 26-week extension phase wherein the BGM Group received the CGM+FBI (BGM-Crossover) and both original CGM groups continued this technology.Results:Time in range (70-180 mg/dL) did not improve with CGM use (CGM+FBI: baseline 37%, 52 weeks 41%; Standard-CGM: baseline 41%, 52 weeks 44%; BGM-Crossover: 26 weeks 38%, 52 weeks 40%). All three groups sustained decreases in hypoglycemia (
      Citation: Journal of Diabetes Science and Technology
      PubDate: 2022-03-26T09:02:34Z
      DOI: 10.1177/19322968221084667
       
  • Predicting Glycated Hemoglobin Through Continuous Glucose Monitoring in
           Real-Life Conditions: Improved Estimation Methods

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      Authors: Marina Valenzano, Ivan Cibrario Bertolotti, Giorgio Grassi, Fabio Broglio, Adriano Valenzano
      Abstract: Journal of Diabetes Science and Technology, Ahead of Print.
      Background:The adoption of continuous glucose monitoring (CGM) already helps to improve glycemic control in diabetes. When coupled with appropriate data analysis techniques, CGM also provides dependable estimates for significant metrics, like glycated hemoglobin (HbA1c). Findings from the REALISM-T1D study can boost HbA1c estimation methods in diabetes care and stimulate their use in clinical practice.Methods:Continuous glucose monitoring data of 27 adults affected by type-1 diabetes were acquired by means of G6 (Dexcom, San Diego, CA) sensors for a time span of 120 days. Glycated hemoglobin laboratory assays were performed during the concluding follow-up visits. Data were then analyzed to derive estimates of assay results, taken as the gold standard.Results:Bland-Altman (BA) plots show that smart interpolation to patch missing data and a wise choice of interstitial glucose (IG) weighting function, besides a proper mean interstitial glucose (MIG) to HbA1c regression equation, improve HbA1c estimation quality with respect to methods relying on MIG alone. A decrease in the BA plot-related variance of differences with respect to the gold standard confirms the improvement. Wilcoxon signed-rank tests on the bias-compensated mean squared error (MSE) with respect to conventional MIG-based methods show that the improvement is statistically significant with a confidence level better than 95% (P = .0179).Conclusions:Improved HbA1c estimation methods result in better HbA1c prediction quality with respect to those based on MIG alone, thus providing quick, but still relatively accurate feedback to diabetologists. They alleviate the discordances reported in literature and, with further improvements, may become a viable complement/alternative to HbA1c assays.
      Citation: Journal of Diabetes Science and Technology
      PubDate: 2022-03-15T05:49:02Z
      DOI: 10.1177/19322968221081556
       
  • Development and Validation of the Diabetes Pen Experience Measure (DPEM):
           A New Patient-Reported Outcome Measure

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      Authors: Meryl Brod, Laura Tesler Waldman, Thomas Sparre, Anne Kirstine Busk
      Abstract: Journal of Diabetes Science and Technology, Ahead of Print.
      Background:Satisfaction with insulin-delivery devices has been shown to improve treatment adherence, translating into better glycemic control. The Diabetes Pen Experience Measure (DPEM) is a new patient-reported outcome measure to evaluate patients’ experience when using an injection device.Methods:The DPEM was developed using literature review and concept elicitation interviews with clinical experts and patients. This led to a theoretical model and a draft measure of the diabetes pen experience, which was refined following cognitive debriefing. Validation entailed a web-based, noninterventional survey; psychometric analyses conducted according to a statistical analysis plan; and refinement and finalization of the DPEM and theoretical model.Results:In total, 42 patients participated in concept elicitation interviews. Analysis of the qualitative interviews resulted in a preliminary theoretical model. Based on this model, DPEM items were generated; the preliminary version of the DPEM contained 30 items. Following cognitive debriefing, the validation-ready version comprised 28 items. These were later reduced to 7 higher-order items owing to ceiling/floor effects. In total, 300 patients participated in the web-based validation study. The item statistics were all adequate. Item-to-item correlations were good. Item-to-total correlations displayed acceptable associations between each item against the rest of the items, with correlations of 0.68 to 0.79. The internal consistency was adequate, with a Cronbach’s alpha of 0.91. The DPEM is scored by summing the 7 item scores and transforming the sum onto a 100-point scale.Conclusion:The evidence presented supports the use of the DPEM in clinical trials to evaluate the patients’ experience with diabetes injection devices.
      Citation: Journal of Diabetes Science and Technology
      PubDate: 2022-03-15T05:43:50Z
      DOI: 10.1177/19322968221079396
       
  • Language Matters in Diabetes and in Diabetes Science and Research

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      Authors: Dana M. Lewis
      Abstract: Journal of Diabetes Science and Technology, Ahead of Print.

      Citation: Journal of Diabetes Science and Technology
      PubDate: 2022-03-14T09:42:59Z
      DOI: 10.1177/19322968221085028
       
  • Real-World Use of Continuous Glucose Monitoring (CGM) Systems Among
           Adolescents and Young Adults With Type 1 Diabetes: Reduced Burden, but
           Little Interest in Data Analysis

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      Authors: Friederike Huhn, Karin Lange, Mia Jördening, Gundula Ernst
      Abstract: Journal of Diabetes Science and Technology, Ahead of Print.
      Background:Since 2016, German health insurance companies reimburse continuous glucose monitoring (CGM) systems for persons with insulin-dependent diabetes, leading to a tremendous increase of CGM use. This study assessed the use of CGM, the satisfaction with, and the data analysis behavior among young people.Methods:During a diabetes camp for young people from all over Germany, participants anonymously answered a questionnaire on their method of glucose monitoring, satisfaction and quality of CGM use, HbA1c, and diabetes distress (Problem Areas in Diabetes Scale [PAID]-5).Results:A total of 308 participants (age 21.4 ± 3.5 years; 73% female; diabetes duration 10.1 ± 5.9 years) completed the questionnaire. Approximately, 25% used self-monitoring of blood glucose (SMBG), 46% intermittent-scanning continuous glucose monitoring (iscCGM), and 30% real-time continuous glucose monitoring (rtCGM). Mean HbA1c was slightly, but not significantly, higher among SMBG users compared with CGM users (8.0% ± 1.9% vs. 7.7% ± 1.4%; P = .791). Diabetes distress was not associated with the method of glucose monitoring (SMBG 5.6 vs. iscCGM 6.2 vs. rtCGM 6.5; P = .386). Overall, satisfaction with CGM use was very high; 98% of the CGM users reported better well-being with CGM compared with previous SMBG use. Only 19% of CGM users reported regular data analyses; their HbA1c was lower compared with other CGM users (7.2% ± 1.2% vs. 7.7% ± 1.4%; P = .039).Conclusions:In this large sample of young people, 75% were using a CGM system. Treatment satisfaction was very high, but CGM use was not associated with reduced diabetes distress or better glycemic control. However, young people who regularly analyzed their CGM data reported lower HbA1c levels.
      Citation: Journal of Diabetes Science and Technology
      PubDate: 2022-03-08T07:05:50Z
      DOI: 10.1177/19322968221081216
       
  • Variability of Glycemic Outcomes and Insulin Requirements Throughout the
           Menstrual Cycle: A Qualitative Study on Women With Type 1 Diabetes Using
           an Open-Source Automated Insulin Delivery System

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      Authors: Darius Mewes, Mandy Wäldchen, Christine Knoll, Klemens Raile, Katarina Braune
      Abstract: Journal of Diabetes Science and Technology, Ahead of Print.
      Background:The impact of hormone dynamics throughout the menstrual cycle on insulin sensitivity represents a currently under-researched area. Despite therapeutic and technological advances, self-managing insulin therapy remains challenging for women with type 1 diabetes (T1D).Methods:To investigate perceived changes in glycemic levels and insulin requirements throughout the menstrual cycle and different phases of life, we performed semi-structured interviews with 12 women with T1D who are using personalized open-source automated insulin delivery (AID) systems. Transcripts were analyzed using thematic analysis with an inductive, hypothesis-generating approach.Results:Participants reported significant differences between the follicular phase, ovulation, and luteal phase of the menstrual cycle and also during puberty, pregnancy, and menopause. All participants reported increased comfort and safety since using AID, but were still required to manually adjust their therapy according to their cycle. A lack of information and awareness and limited guidance by health care providers were frequently mentioned. Although individual adjustment strategies exist, achieving optimum outcomes was still perceived as challenging.Conclusions:This study highlights that scientific evidence, therapeutic options, and professional guidance on female health-related aspects in T1D are insufficient to date. Further efforts are required to better inform people with T1D, as well as for health care professionals, researchers, medical device manufacturers, and regulatory bodies to better address female health needs in therapeutic advances.
      Citation: Journal of Diabetes Science and Technology
      PubDate: 2022-03-07T02:37:16Z
      DOI: 10.1177/19322968221080199
       
  • Evaluation of a New Clinical Tool to Enhance Clinical Care of Control-IQ
           Users

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      Authors: Laurel H. Messer, Cari Berget, Sophia Centi, Bryan Mcnair, Gregory P. Forlenza
      Abstract: Journal of Diabetes Science and Technology, Ahead of Print.
      Background:The purpose of this study was to develop and test a new Clinic Tool to assist health care professionals with clinical care of persons with diabetes using the Control-IQ system.Methods:A Clinic Tool was iteratively developed with input from diabetes clinicians, which outlined a systematic process for assessing data, reviewing insulin settings, providing education, and documenting the encounter. Diabetes clinicians were recruited to trial the Clinical Tool in up to five clinical encounters (in-person, telehealth, or telephone). Quantitative surveys and free-text responses, including a knowledge quiz and the System Usability Scale (SUS), were administered to determine clinician satisfaction, confidence, knowledge, and implications for practice.Results:Twenty-nine clinicians (43% endocrinologists, mean 10.7 years in practice) enrolled in the study and completed 89 encounters using the Control-IQ Clinic Tool. Participants spent an average of 10 minutes using the Tool and reported excellent SUS scores within the 90%-95% percentile for usability. Knowledge quiz scores increased in 42% of participants. Both familiarity with Control-IQ and confidence providing clinical care to Control-IQ users significantly improved (P = .009 and P < .001 respectively). Ninety percent of participants agreed that the Tool will change their clinical care going forward.Conclusion:The Control-IQ Clinical Tool is highly usable and impacted clinical care delivery to Control-IQ users. Tools that serve to improve clinician confidence in delivery of care to diabetes device users should be expanded, leveraged, and studied to assess the impact on adherence and glycemic control for persons with diabetes.
      Citation: Journal of Diabetes Science and Technology
      PubDate: 2022-03-01T06:40:41Z
      DOI: 10.1177/19322968221081890
       
  • Role of Telemedicine in Diabetes Management

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      Authors: Rajnish Dhediya, Manoj Chadha, Arpan D. Bhattacharya, Shreerang Godbole, Shreeharsh Godbole
      Abstract: Journal of Diabetes Science and Technology, Ahead of Print.
      Introduction:Telemedicine is a growing arena that may increase access to care for patients with diabetes. It has more relevance for rural populations or those with limited physical access to health care, for improving diabetes care. Telemedicine can also be used to offer diabetes self-education and transportation barriers for patients living in under-resourced areas or with disabilities.Method"This review explores the landscape of telemedicine approaches and evidence for incorporation into general practice.Results & Discussion:Telehealth platforms have been shown to be both feasible and effective for health care delivery in diabetes, although there are many caveats that require tailoring to the institution, clinician, and patient population. Research in diabetes telehealth should focus next on how to increase access to patients who are known to be marginalized from traditional models of health care.
      Citation: Journal of Diabetes Science and Technology
      PubDate: 2022-03-01T06:39:52Z
      DOI: 10.1177/19322968221081133
       
  • Impact of Blood Glucose Monitoring System Accuracy on Clinical Decision
           Making for Diabetes Management

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      Authors: Manuel Eichenlaub, Stefan Pleus, Rimma Shaginian, James Richardson, Scott Pardo, Andreas Stuhr, Guido Freckmann
      Abstract: Journal of Diabetes Science and Technology, Ahead of Print.
      Background:The accuracy of blood glucose monitoring systems (BGMS) is crucial for the safe and effective management of diabetes mellitus. Despite standardization of accuracy assessment procedures and requirements, various studies have shown that the accuracy of BGMS on the market can vary considerably. This article therefore provides health care professionals and users with an intuitive illustration of the impact of BGMS accuracy on clinical decision making.Material and Methods:Several hypothetical patient scenarios based on blood glucose (BG) levels in the low, normal, and high BG range are devised. Using data from a recent BGMS accuracy study, a method for calculating the expected range of BG readings from four examined BGMS at the selected BG levels is introduced. Based on these ranges, it is illustrated how clinical decisions and subsequent outcomes of the hypothetical patients are affected by the expected inaccuracies of the BGMS.Results:The range of expected BGMS readings for the same true BG level can vary considerably between different BGMS. The discussion of hypothetical patient scenarios revealed that the use of some BGMS could be associated with an increased risk of adverse events such as failure to detect hypoglycemia, driving with an unsafe BG level, delay of treatment intervention in diabetes during pregnancy, or the failure to prevent diabetic ketoacidosis.Conclusions:This article can support both health care professionals and patients to understand the impact of BGMS accuracy in a relatable, clinical context. Furthermore, it is suggested that current accuracy requirements might be insufficient for the prevention of adverse clinical outcomes in certain circumstances.
      Citation: Journal of Diabetes Science and Technology
      PubDate: 2022-03-01T06:39:33Z
      DOI: 10.1177/19322968221080916
       
  • External Physical and Technical Influences on Medical Devices for Diabetes
           Therapy

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      Authors: Andreas Thomas, Lutz Heinemann
      Abstract: Journal of Diabetes Science and Technology, Ahead of Print.
      Home and work situations can expose diabetes medical devices to a number of environmental factors that may influence their function and safety. In accordance with regulatory requirements, manufacturing companies take great care in the construction and design of their products so that environmental factors encountered on a daily basis have as little influence as possible. However, more intense environmental conditions, such as undergoing magnetic resonance imaging (MRI), require patients to remove personal electronic medical devices beforehand. During product development, manufacturers thoroughly investigate how various environmental factors may impact a new medical device. Corresponding operational documents and manufacturer guarantees accompany each device. Similarly, manufacturers investigate any adverse interactions that may occur during communications between medical devices, such as those required with another product, smartphone, or another personal medical device, such as a pacemaker. Questions that arise from patients or medical professionals about a medical device’s safety or quality, particularly because of environmental factors, are made to the manufacturer. Manufacturers then often refer to the operating instructions, even though these contain information, such as electromagnetic compatibility, that are difficult to understand for people lacking special technical or physical knowledge. This review highlights the effects of various physical and technical influences on medical devices used in diabetes therapy.
      Citation: Journal of Diabetes Science and Technology
      PubDate: 2022-02-23T06:15:37Z
      DOI: 10.1177/19322968221080160
       
  • A Long-Term Evaluation of Facebook for Recruitment and Retention in the
           ENDIA Type 1 Diabetes Pregnancy-Birth Cohort Study

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      Authors: Kelly J. McGorm, James D. Brown, Rebecca L. Thomson, Helena Oakey, Belinda Moore, Alexandra Hendry, Peter G. Colman, Maria E. Craig, Elizabeth A. Davis, Mark Harris, Leonard C. Harrison, Aveni Haynes, Georgia Soldatos, Peter Vuillermin, John M. Wentworth, Jennifer J. Couper, Megan A. S. Penno
      Abstract: Journal of Diabetes Science and Technology, Ahead of Print.
      Background:The Environmental Determinants of Islet Autoimmunity (ENDIA) study is an Australia-wide pregnancy-birth cohort study following children who have a first-degree relative with type 1 diabetes (ACTRN1261300794707). A dedicated ENDIA Facebook page was established in 2013 with the aim of enhancing recruitment and supporting participant retention through dissemination of study information. To measure the impact of Facebook, we evaluated the sources of referral to the study, cohort demographics, and withdrawal rates. We also investigated whether engagement with Facebook content was associated with specific post themes.Methods:Characteristics of Facebook versus conventional recruits were compared using linear, logistic, and multinomial logistic regression models. Logistic regression was used to determine the risk of study withdrawal. Data pertaining to 794 Facebook posts over 7.5 years were included in the analysis.Results:Facebook was the third largest source of referral (300/1511; 19.9%). Facebook recruits were more frequently Australian-born (P < .001) enrolling postnatally (P = .01) and withdrew from the study at a significantly lower rate compared with conventional recruits (4.7% vs 12.3%; P < .001) after a median of follow-up of 3.3 years. Facebook content featuring stories and images of participants received the highest engagement even though
      Citation: Journal of Diabetes Science and Technology
      PubDate: 2022-02-23T06:14:25Z
      DOI: 10.1177/19322968221079867
       
  • Intraperitoneal Insulin Delivery: Evidence of a Physiological Route for
           Artificial Pancreas From Compartmental Modeling

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      Authors: Jorge Lo Presti, Alfonso Galderisi, Francis J. Doyle, Howard C. Zisser, Eyal Dassau, Eric Renard, Chiara Toffanin, Claudio Cobelli
      Abstract: Journal of Diabetes Science and Technology, Ahead of Print.
      BackgroundIntraperitoneal insulin delivery has proven to safely overcome a major limit of subcutaneous delivery—meal announcement—and has been able to optimize glycemic control in adults under controlled experimental conditions. In addition, intraperitoneal delivery avoids peripheral hyperinsulinemia resulting from the subcutaneous route and restores a physiological liver gradient.MethodsRelying on a unique data set of intraperitoneal closed-loop insulin delivery obtained with a Model Predictive Controller (MPC), we develop a compartmental model of intraperitoneal insulin kinetics, which, once included in the UVa/Padova T1D simulator, will facilitate the investigation of various control strategies, for example, the simpler Proportional Integral Derivative controller versus MPC.ResultsIntraperitoneal insulin kinetics can be described with a 2-compartment model including liver and plasma.ConclusionIntraperitoneal insulin transit is fast enough to render irrelevant the addition of a peritoneal compartment, proving the peritoneum being a virtual—not actual—transit space for insulin delivery.
      Citation: Journal of Diabetes Science and Technology
      PubDate: 2022-02-11T06:44:08Z
      DOI: 10.1177/19322968221076559
       
  • An Opportunity for Improvement: Evaluation of Diabetes Technology
           Education Among Adult Endocrinology Training Programs

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      Authors: Kathryn L. Fantasia, Lindsay B. Demers, Devin W. Steenkamp, Katherine L. Modzelewski
      Abstract: Journal of Diabetes Science and Technology, Ahead of Print.
      Background:Despite increases in continuous glucose monitor (CGM) and insulin pump use in adults with diabetes, there is room for expansion. Technology adoption may be influenced by the training environment and fellowship education. However, little is known about adult endocrinology trainee comfort with, understanding of, or methods by which trainees receive education about diabetes technology.Methods:Mixed methods, sequential explanatory evaluation using survey and semi-structured interviews of endocrinology trainees and fellowship leadership in Accreditation Council for Graduate Medical Education (ACGME)-accredited adult endocrinology fellowship programs to assess trainee and leadership comfort with, perceived knowledge of, and current methods for diabetes technology education.Results:Seventy-seven respondents completed the survey. The majority of training programs have curricula for training on insulin pumps (74%) and CGM (75.3%); 52% of fellows felt curricula are adequate. First- and second-year fellows were more comfortable with CGM than insulin pump use. Only half of third-year fellows felt comfortable with starting insulin pump therapy or recommending insulin dose adjustments based on CGM rate of change arrows. Qualitative interviews identified the importance of both direct instruction and experiential learning in diabetes technology education.Conclusions:Almost half of trainees feel that curricula for learning to use and manage insulin pumps and CGM are inadequate and feel uncomfortable with critical aspects of technology use, demonstrating the need for increased attention to trainee education in the use of diabetes technology. Based on a better understanding of current and preferred methods for instruction, this study provides direction for future development of initiatives to improve fellow education in this field.
      Citation: Journal of Diabetes Science and Technology
      PubDate: 2022-02-09T09:31:38Z
      DOI: 10.1177/19322968221077132
       
  • The Effectiveness of Telemedicine Solutions in Type 1 Diabetes Management:
           A Systematic Review and Meta-analysis

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      Authors: Flemming Witt Udsen, Stine Hangaard, Clara Bender, Jonas Andersen, Thomas Kronborg, Peter Vestergaard, Ole Hejlesen, Sisse Laursen
      Abstract: Journal of Diabetes Science and Technology, Ahead of Print.
      Background:Telemedicine holds a potential to strengthen self-management support outside health care settings in the everyday management of type 1 diabetes (T1D). However, existing effectiveness reviews are older or include a relatively narrow focus on specific definitions of telemedicine or included databases.Objective:To conduct a systematic review of the effectiveness of telemedicine solutions versus any comparator on diabetes-related outcomes among people with T1D.Methods:Studies including adults (≥18 years) with T1D published before October 14, 2020, were eligible. Primary outcome was glycated hemoglobin (HbA1c, %). The Cochrane Library, PubMed, EMBASE, and CINAHL were searched. Meta-analysis based on the mean difference in HbA1c% was used to pool effects. The Cochrane tool was applied to assess risk-of-bias, and the certainty of evidence was graded using the GRADE approach.Results:A total of 22 studies were included (with 1615 participants). Treatment effect for HbA1c% favored telemedicine (mean difference of −0.26% [95% confidence interval:−0.37% to −0.15%]) with moderate effect certainty. Heterogeneity was moderate (I2 = 33.30%). Although not significant, secondary outcomes were all in favor of telemedicine except number of severe hypoglycemic events and diabetes knowledge, but the certainty of the evidence for those outcomes was all low or very low.Discussion:Reducing average HbA1c% levels are important to combat the risk of diabetic complications and premature death. However, the evidence mostly consist of small studies with a relative short duration and the estimated pooled effect is smaller than could be expected from quality improvement strategies in general for diabetes management.PROSPERO number:CRD42020123565.
      Citation: Journal of Diabetes Science and Technology
      PubDate: 2022-02-09T09:29:58Z
      DOI: 10.1177/19322968221076874
       
  • Body Composition Prediction—BOMP: A New Tool for Assessing Fat and
           Lean Body Mass

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      Authors: Simon Lebech Cichosz, Peter Vestergaard, Ole Hejlesen
      Abstract: Journal of Diabetes Science and Technology, Ahead of Print.
      Background:Pragmatic and easy-to-use alternatives to estimating body composition, such as lean body mass and fat mass, could be valuable tools for assessing the risk of diabetes or other metabolic diseases. Previous work has shown how demographic and anthropometric data could be used in a neural network to estimate body composition with high precision. However, there is still a need for a publicly available and user-friendly format before these results can have clinical impact.Methods:We used data from 18 430 NHANES participants and stepwise linear regression with inclusion of linear, interactions, and quadratic terms to model lean body and fat mass. HTML and Javascript was used to develop a webapp as a frontend of the model.Results:The models had a correlation cofficent R = 0.99-0.98 (P < .001) withstandard error of estimate [SEE] = 2.07-2.05.Conclusions:The results indicate that it is possible to develop a “white-box” model with high precision.The proof of concept webapp is available as open source under the MIT license.
      Citation: Journal of Diabetes Science and Technology
      PubDate: 2022-02-09T09:28:17Z
      DOI: 10.1177/19322968221076560
       
  • The Need for Diabetes Advance Directives to Support the Care of People
           With Diabetes

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      Authors: Dana M. Lewis
      Abstract: Journal of Diabetes Science and Technology, Ahead of Print.
      It is time to adopt an advance directive specific to diabetes management. Research shows that people with diabetes in the hospital are often removed from existing diabetes self-management, resulting in poorer outcomes. Diabetes advance directives, which outline preferred diabetes self-management in scenarios such as hospitalization or outpatient procedures, are key for enabling patients with diabetes to continue successful diabetes management including use of existing diabetes technology. A diabetes advance directive is a new concept for both patients and providers that can improve clinical outcomes and patient-reported outcomes. Given the risk of harm in the absence of such a document, diabetes advance directives can be a useful new tool for patients and providers and to aid in the discussion, care planning, and self-management with diabetes technology.
      Citation: Journal of Diabetes Science and Technology
      PubDate: 2022-02-09T09:26:59Z
      DOI: 10.1177/19322968221076558
       
  • Key Considerations for Understanding Usability of Digital Health
           Initiatives for Adults With Type 2 Diabetes: A Systematic Qualitative
           Literature Review

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      Authors: Larissa Hall, Md Shahidul Islam
      Abstract: Journal of Diabetes Science and Technology, Ahead of Print.
      Aims:The rapidly growing number of adults with type 2 diabetes globally means the uses and benefits of digital health initiatives to enhance self-management of diabetes warrant review. This systematic qualitative literature review aimed to understand usability of digital health initiatives for adults with type 2 diabetes.Methods:This systematic qualitative literature review was conducted according to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses, the PRISMA 2020 Statement methodology. Three databases were used (SCOPUS, Medline, and CINAHL) to identify studies published from 2016 to 2021 that focused on experiences, evaluations, and usability of digital health initiatives aimed at helping adults with type 2 diabetes to self-manage their condition.Results:From the 407 studies identified, 35 studies were assessed for eligibility with 10 studies included in the final synthesis. Five main themes emerged: (1) unmet emotional needs, (2) enhancing self-management, (3) desire for education, (4) usability/user-experience, and (5) risk of biomedical marker reductionism.Conclusions:This review identified 5 key themes for consideration to understand usability of digital health initiatives. If these unmet psychosocial needs of adults with type 2 diabetes are better addressed in digital health initiatives, enhanced daily self-management will lead to more optimal diabetes management which can increase overall health outcomes, reduce the risk of longer-term complications, enhance quality of life for type 2 diabetes and improve more widespread adoption of digital health initiatives.
      Citation: Journal of Diabetes Science and Technology
      PubDate: 2022-02-07T12:19:41Z
      DOI: 10.1177/19322968221075322
       
  • Safety and Effectiveness of the Use of an Electronic Glucose Monitoring
           System Versus Weight-Based Dosing Nomogram for Treatment of Diabetic
           Ketoacidosis and Hyperglycemic Hyperosmolar Syndrome in a VA Hospital

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      Authors: Madeline Brown, Justin Roberts, Cole Smith, Dakota Eash
      Abstract: Journal of Diabetes Science and Technology, Ahead of Print.
      Objective:The objective of this study is to assess the safety and effectiveness of an electronic glucose monitoring system (eGMS) versus paper-based protocols (PBPs) to manage diabetic ketoacidosis (DKA) and hyperglycemic hyperosmolar syndrome (HHS) within the VA setting.Methods:This study is a retrospective chart review of patients on an insulin drip, treated in the emergency department (ED) or intensive care unit (ICU) at Veteran Health Indiana for DKA or HHS. The primary outcome was evaluating the percentage of patients with hypoglycemia (blood glucose [BG] level
      Citation: Journal of Diabetes Science and Technology
      PubDate: 2022-02-07T12:16:33Z
      DOI: 10.1177/19322968221074710
       
  • Accuracy of Continuous Glucose Monitors for Inpatient Diabetes Management

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      Authors: Jordan J. Wright, Alexander J. Williams, Sally B. Friedman, Rita G. Weaver, Jonathan M. Williams, Elizabeth Hodge, Michael Fowler, Shichun Bao
      Abstract: Journal of Diabetes Science and Technology, Ahead of Print.
      Introduction:In hospitalized patients, continuous glucose monitoring (CGM) may improve glycemic control, prevent hypoglycemic events, and reduce staff workload compared with point-of-care (POC) capillary glucose monitoring.Methods:To evaluate CGM accuracy and safety of use in the inpatient setting, two versions of CGM sensors were placed on 43 and 34 adult patients with diabetes admitted to non-intensive care unit (ICU) medical wards, respectively. CGM accuracy relative to POC and safety of use were measured by calculating mean absolute relative difference (MARD) and by Clarke Error Grid (CEG) analysis.Results:CGM version 2 had improved accuracy compared with CGM version 1 with MARD 17.7 compared with 21.4%. CGM accuracy did not change with POC value or with time of sensor wear. On CEG, 98.8% of paired values fell within acceptable zones A and B.Conclusion:Despite reduced accuracy compared with the outpatient setting, both versions of CGMs had acceptable safety profiles in the inpatient setting.
      Citation: Journal of Diabetes Science and Technology
      PubDate: 2022-02-07T12:14:14Z
      DOI: 10.1177/19322968221076562
       
  • Navigating Diabetes Online Communities in Clinical Practice

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      Authors: Meghan McLarney, Michelle L. Litchman, Deborah Greenwood, Andjela Drincic
      Abstract: Journal of Diabetes Science and Technology, Ahead of Print.
      Objective:This purpose of this study was to conduct a rapid review and environmental scan of diabetes online communities (DOCs) to highlight the clinical impact of DOC engagement and provide guidance to health care providers for navigating and prescribing DOCs.Methods:This two-phase review included a rapid review of clinical outcomes and an assessment of DOC content. We conducted a literature search for studies evaluating DOC use and glucometric (glycated hemoglobin [A1C], time-in-range, hypoglycemia), behavioral, and psychosocial outcomes. The environmental scan of current DOC sites established key features, including available platforms, target population, content areas, and reach.Results:Twelve papers were included—eight reported DOC use within a context of do-it-yourself (DIY) noncommercial, opensource hybrid closed loop systems community and four were non-DYI related. In latter, all studies were cross-sectional, describing patient-reported outcomes. Two studies reported A1C lowering with DOC use, two DOC use was associated with high self-efficacy, one showed association with higher self-care levels, and one showed higher quality of life scores when compared with population norms. All DIY studies showed improvement in glucometrics after initiation of sensor augmented pump technology with DOC support. Of 54 DOC sites reviewed in the environmental scan, 29 were included. Diabetes online community sites were heterogenous in social media platform and type of diabetes targeted.Conclusion:Diabetes online communities have the potential to improve clinical, behavioral, and psychosocial outcomes. Randomized control trials and/or longitudinal prospective studies evaluating outcomes are needed to further examine the potential benefits of DOC use. Diabetes online communities are diverse and span a variety of social media platforms, providing clinicians opportunities to individualize recommendations for DOC use.
      Citation: Journal of Diabetes Science and Technology
      PubDate: 2022-02-05T09:29:01Z
      DOI: 10.1177/19322968211069409
       
  • Clinical Evaluation of a Novel Insulin Immunosensor

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      Authors: Eleonora M. Aiello, Jordan E. Pinsker, Eva Vargas, Hazhir Teymourian, Farshad Tehrani, Mei Mei Church, Lori M. Laffel, Francis J. Doyle, Mary-Elizabeth Patti, Joseph Wang, Eyal Dassau
      Abstract: Journal of Diabetes Science and Technology, Ahead of Print.
      Background:The estimation of available active insulin remains a limitation of automated insulin delivery systems. Currently, insulin pumps calculate active insulin using mathematical decay curves, while quantitative measurements of insulin would explicitly provide person-specific PK insulin dynamics to assess remaining active insulin more accurately, permitting more effective glucose control.Methods:We performed the first clinical evaluation of an insulin immunosensor chip, providing near real-time measurements of insulin levels. In this study, we sought to determine the accuracy of the novel insulin sensor and assess its therapeutic risk and benefit by presenting a new tool developed to indicate the potential therapeutic consequences arising from inaccurate insulin measurements.Results:Nine adult participants with type-1 diabetes completed the study. The change from baseline in immunosensor-measured insulin levels was compared with values obtained by standard enzyme-linked immunosorbant assay (ELISA) after preprandial injection of insulin. The point-of-care quantification of insulin levels revealed similar temporal trends as those from the laboratory insulin ELISA. The results showed that 70% of the paired immunosensor-reference values were concordant, which suggests that the patient could take action safely based on insulin concentration obtained by the novel sensor.Conclusions:This proposed technology and preliminary feasibility evaluation show encouraging results for near real-time evaluation of insulin levels, with the potential to improve diabetes management. Real-time measurements of insulin provide person-specific insulin dynamics that could be used to make more informed decisions regarding insulin dosing, thus helping to prevent hypoglycemia and improve diabetes outcomes.
      Citation: Journal of Diabetes Science and Technology
      PubDate: 2022-02-04T11:29:00Z
      DOI: 10.1177/19322968221074406
       
  • The Benefits of Utilizing Continuous Glucose Monitoring of Diabetes
           Mellitus in Primary Care: A Systematic Review

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      Authors: Alexander Kieu, Jeffrey King, Romona Devi Govender, Linda Östlundh
      Abstract: Journal of Diabetes Science and Technology, Ahead of Print.
      Background:Continuous glucose monitoring (CGM) and intermittently scanned CGM (is-CGM) have shown to effectively manage diabetes in the specialty setting, but their efficacy in the primary care setting remains unknown. Does CGM/is-CGM improve glycemic control, decrease rates of hypoglycemia, and improve staff/physician satisfaction in primary care' If so, what subgroups of patients with diabetes are most likely to benefit'Methods:A comprehensive search in seven databases was performed in June 2021 for primary studies examining any continuous glucose monitoring system in primary care. We excluded studies with fewer than 20 participants, specialty care only, or hospitalized participants. The National Heart, Lung and Blood Institute and Grading of Recommendations Assessment, Development and Evaluation were used for the quality assessment. The weighted mean difference (WMD) of HbA1c between CGM/is-CGM and usual care with 95% confidence interval was calculated. A narrative synthesis was conducted for change of time in, above, or below range (TIR, TAR, and TBR) hypoglycemic events and staff/patient satisfaction.Results:From ten studies and 4006 participants reviewed, CGM was more effective at reducing HbA1c compared with usual care (WMD −0.43%). There is low certainty of evidence that CGM/is-CGM improves TIR, TAR, or TBR over usual care. The CGM can reduce hypoglycemic events and staff/patient satisfaction is high. Patients with intensive insulin therapy may benefit more from CGM/is-CGM.Conclusions:Compared with usual care, CGM/is-CGM can reduce HbA1c, but most studies had notable biases, were short duration, unmasked, and were sponsored by industry. Further research needs to confirm the long-term benefits of CGM/is-CGM in primary care.
      Citation: Journal of Diabetes Science and Technology
      PubDate: 2022-02-01T08:09:52Z
      DOI: 10.1177/19322968211070855
       
  • Smart Offloading Boot System for Remote Patient Monitoring: Toward
           Adherence Reinforcement and Proper Physical Activity Prescription for
           Diabetic Foot Ulcer Patients

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      Authors: Catherine Park, Ramkinker Mishra, Davide Vigano, Maurizio Macagno, Stefano Rossotti, Karen D’Huyvetter, Jason Garcia, David G. Armstrong, Bijan Najafi
      Abstract: Journal of Diabetes Science and Technology, Ahead of Print.
      Background:A critical factor in healing diabetic foot ulcers is patient adherence to offloading devices. We tested a smart offloading boot (SmartBoot) combined with a smartwatch app and cloud dashboard to remotely monitor patient adherence and activity. In addition, the impact of SmartBoot on balance, gait, and user experience was investigated.Methods:Fourteen volunteers (31.6±8.7 years; 64% female) performed natural activities (eg, sitting, standing, walking) with and without the SmartBoot for approximately 30 minutes. All participants completed balance tests, 10-meter walking tests at slow, normal, and fast pace while wearing the SmartBoot, and a user experience questionnaire. The accuracy of real-time adherence reporting was assessed by comparing the SmartBoot and staff observation. Center of mass (COM) sway and step counts were measured using a validated wearable system.Results:Average sensitivity, specificity, and accuracy for adherence and non-adherence were 90.6%, 88.0%, and 89.3%, respectively. The COM sway area was significantly smaller with the SmartBoot than without the SmartBoot regardless of test condition. Step count error was 4.4% for slow waking, 36.2% for normal walking, 16.0% for fast walking. Most participants agreed that the SmartBoot is easy to use, relatively comfortable, nonintrusive, and innovative.Conclusions:To our knowledge, this is the first smart offloading system that enables remote patient monitoring and real-time adherence and activity reporting. The SmartBoot enhanced balance performance, likely due to somatosensory feedback. Questionnaire results highlight SmartBoot’s technical and clinical potential. Future studies warrant clinical validation of real-time non-adherence alerting to improve wound healing outcomes in people with diabetic foot ulcers.
      Citation: Journal of Diabetes Science and Technology
      PubDate: 2022-01-20T11:27:18Z
      DOI: 10.1177/19322968211070850
       
  • Development of a Novel Insulin Sensor for Clinical Decision-Making

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      Authors: Eva Vargas, Eleonora M. Aiello, Jordan E. Pinsker, Hazhir Teymourian, Farshad Tehrani, Mei Mei Church, Lori M. Laffel, Francis J. Doyle, Mary-Elizabeth Patti, Eyal Dassau, Joseph Wang
      Abstract: Journal of Diabetes Science and Technology, Ahead of Print.
      Background:Clinical decision support systems that incorporate information from frequent insulin measurements to enhance individualized diabetes management remain an unmet goal. The development of a disposable insulin strip for fast decentralized point-of-care detection replacing the current centralized lab-based methods used in clinical practice would be highly desirable to improve the establishment of individual insulin absorption patterns and algorithm modeling processes.Methods:We carried out the development and optimization of a novel decentralized disposable insulin electrochemical sensor focusing on obtaining high analytical and operational performance toward achieving a true point-of-care insulin testing device for clinical on-site application.Results:Our novel insulin immunosensor demonstrated an attractive performance and efficient user-friendly operation by providing high sensitivity capability to detect endogenous and analog insulin with a limit of detection of 30.2 pM (4.3 µiU/mL), rapid time-to-result, stability toward remote site application, and scalable low-cost fabrication with an estimated cost-of-goods for disposable consumables of below $5, capable of near real-time insulin detection in a microliter (≤10 µL) sample droplet of undiluted serum within 30 minutes.Conclusions:The results obtained in the optimization and characterization of our novel insulin sensor illustrate its suitability for its potential application in remote clinical environments for frequent insulin monitoring. Future work will test the insulin sensor in a clinical research setting to assess its efficacy in individuals with type 1 diabetes.
      Citation: Journal of Diabetes Science and Technology
      PubDate: 2022-01-19T10:54:15Z
      DOI: 10.1177/19322968211071132
       
  • Use of Retrospective Continuous Glucose Monitoring Data Is Underrated and
           Underused

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      Authors: Quang Nguyen, Anish Arul Iyyavoo, Christopher G. Parkin
      Abstract: Journal of Diabetes Science and Technology, Ahead of Print.
      Access to real-time glucose data in real time allows users to make informed decisions about their insulin dosages, appropriate carbohydrate intake, exercise, and other health behaviors. Programmable alarms and alerts warn users about current and/or impending acute glycemic events. However, the value and utility of retrospective data analysis for clinical decision-making have gone mostly unrecognized. This article presents a series of patient case examples that illustrate how our use of retrospective data enables us to identify and effectively address patterns of problematic glycemia.
      Citation: Journal of Diabetes Science and Technology
      PubDate: 2022-01-19T10:51:51Z
      DOI: 10.1177/19322968211070837
       
  • In Vitro Evaluation of Miniaturized Amperometric Enzyme Sensor Based on
           the Direct Electron Transfer Principle for Continuous Glucose Monitoring

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      Authors: Yutaro Inoue, Yasuhide Kusaka, Kotaro Shinozaki, Inyoung Lee, Koji Sode
      Abstract: Journal of Diabetes Science and Technology, Ahead of Print.
      Background:The bacterial derived flavin adenine dinucleotide (FAD)-dependent glucose dehydrogenase (FADGDH) is the most promising enzyme for the third-generation principle-based enzyme sensor for continuous glucose monitoring (CGM). Due to the ability of the enzyme to transfer electrons directly to the electrode, recognized as direct electron transfer (DET)-type FADGDH, although no investigation has been reported about DET-type FADGDH employed on a miniaturized integrated electrode.Methods:The miniaturized integrated electrode was formed by sputtering gold (Au) onto a flexible film with 0.1 mm in thickness and divided into 3 parts. After an insulation layer was laminated, 3 openings for a working electrode, a counter electrode and a reference electrode were formed by dry etching. A reagent mix containing 1.2 × 10−4 Unit of DET-type FADGDH and carbon particles was deposited. The long-term stability of sensor was evaluated by continuous operation, and its performance was also evaluated in the presence of acetaminophen and the change in oxygen partial pressure (pO2) level.Results:The amperometric response of the sensor showed a linear response to glucose concentration up to 500 mg/dL without significant change of the response over an 11-day continuous measurement. Moreover, the effect of acetaminophen and pO2 on the response were negligible.Conclusions:These results indicate the superb potential of the DET-type FADGDH-based sensor with the combination of a miniaturized integrated electrode. Thus, the described miniaturized DET-type glucose sensor for CGM will be a promising tool for effective glycemic control. This will be further investigated using an in vivo study.
      Citation: Journal of Diabetes Science and Technology
      PubDate: 2022-01-06T07:06:21Z
      DOI: 10.1177/19322968211070614
       
  • Optimal Data Collection Period for Continuous Glucose Monitoring to Assess
           Long-Term Glycemic Control: Revisited

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      Authors: Simon Lebech Cichosz, Morten Hasselstrøm Jensen, Ole Hejlesen
      Abstract: Journal of Diabetes Science and Technology, Ahead of Print.
      Background and Objective:It is not clear how the short-term continuous glucose monitoring (CGM) sampling time could influence the bias in estimating long-term glycemic control. A large bias could, in the worst case, lead to incorrect classification of patients achieving glycemic targets, nonoptimal treatment, and false conclusions about the effect of new treatments. This study sought to investigate the relation between sampling time and bias in the estimates.Methods:We included a total of 329 type 1 patients (age 14-86 years) with long-term CGM (90 days) data from three studies. The analysis calculated the bias from estimating long-term glycemic control based on short-term sampling. Time in range (TIR), time above range (TAR), time below range (TBR), correlation, and glycemic target classification accuracy were assessed.Results:A sampling time of ten days is associated with a high bias of 10% to 47%, which can be reduced to 4.9% to 26.4% if a sampling time of 30 days is used (P < .001). Correct classification of patients archiving glycemic targets can also be improved from 81.5% to 91.9 to 90% to 95.2%.Conclusions:Our results suggest that the proposed 10-14 day CGM sampling time may be associated with a high correlation with three-month CGM. However, these estimates are subject to large intersubject bias, which is clinically relevant. Clinicians and researchers should consider using assessments of longer durations of CGM data if possible, especially when assessing time in hypoglycemia or while testing a new treatment.
      Citation: Journal of Diabetes Science and Technology
      PubDate: 2022-01-06T07:04:33Z
      DOI: 10.1177/19322968211069177
       
  • Cost-Utility of an Online Education Platform and Diabetes Personal Health
           Record: Analysis Over Ten Years

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      Authors: Scott G. Cunningham, Andrew Stoddart, Sarah H. Wild, Nicholas J. Conway, Alastair M. Gray, Deborah J. Wake
      Abstract: Journal of Diabetes Science and Technology, Ahead of Print.
      Background and Aims:My Diabetes My Way (MDMW) is Scotland’s interactive website and mobile app for people with diabetes and their caregivers. It contains multimedia resources for diabetes education and offers access to electronic personal health records. This study aims to assess the cost-utility of MDMW compared with routine diabetes care in people with type 2 diabetes who do not use insulin.Materials and Methods:Analysis used the United Kingdom Prospective Diabetes Study (UKPDS) Outcomes Model 2. Clinical parameters of MDMW users (n = 2576) were compared with a matched cohort of individuals receiving routine care alone (n = 11 628). Matching criteria: age, diabetes duration, sex, and socioeconomic status. Impact on life expectancy, quality-adjusted life years (QALYs), and costs of treatment and complications were simulated over ten years, including a 10% sensitivity analysis.Results:MDMW cohort: 1670 (64.8%) men; average age 64.3 years; duration of diabetes 5.5 years. 906 (35.2%) women: average age 61.6 years; duration 4.7 years. The cumulative mean QALY (95% CI) gain: 0.054 (0.044-0.062) years. Mean difference in cost: –£118.72 (–£150.16 to –£54.16) over ten years. Increasing MDMW costs (10%): –£50.49 (–£82.24-£14.14). Decreasing MDMW costs (10%): –£186.95 (–£218.53 to –£122.51).Conclusions:MDMW is “dominant” over usual care (cost-saving and life improving) in supporting self-management in people with type 2 diabetes not treated with insulin. Wider use may result in significant cost savings through delay or reduction of long-term complications and improved QALYs in Scotland and other countries. MDMW may be among the most cost-effective interventions currently available to support diabetes.
      Citation: Journal of Diabetes Science and Technology
      PubDate: 2022-01-06T07:02:51Z
      DOI: 10.1177/19322968211069172
       
  • Treating an Unconscious Patient With Diabetes Wearing a Device Attached to
           Their Body

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      Authors: Lutz Heinemann, Kevin T. Nguyen, Nicole Y. Xu, Gregory H. Gilbert, David C. Klonoff
      First page: 583
      Abstract: Journal of Diabetes Science and Technology, Ahead of Print.

      Citation: Journal of Diabetes Science and Technology
      PubDate: 2022-03-16T09:10:22Z
      DOI: 10.1177/19322968221081888
       
  • Improving the Patient Experience With Longer Wear Infusion Sets Symposium
           Report

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      Authors: Kevin T. Nguyen, Nicole Y. Xu, Bruce A. Buckingham, Sarnath Chattaraj, Ohad Cohen, Lutz Heinemann, John Pickup, Jannet Svensson, Robert A. Vigersky, Jenise C. Wong, Ralph Ziegler
      First page: 775
      Abstract: Journal of Diabetes Science and Technology, Ahead of Print.
      Continuous subcutaneous insulin infusion (CSII) therapy is becoming increasingly popular. CSII provides convenient insulin delivery, precise dosing, easy adjustments for physical activity, stress, or illness, and integration with continuous glucose monitors in hybrid or other closed-loop systems. However, even as insulin pump hardware and software have advanced, technology for insulin infusion sets (IISs) has stayed relatively stagnant over time and is often referred to as the “Achilles heel” of CSII. To discuss barriers to insulin pump therapy and present information about advancements in, and results from clinical trials of extended wear IISs, Diabetes Technology Society virtually hosted the “Improving the Patient Experience with Longer Wear Infusion Sets Symposium” on December 1, 2021. The symposium featured experts in the field of IISs, including representatives from Steno Diabetes Center Copenhagen, University of California San Francisco, Stanford University, Medtronic Diabetes, and Science Consulting in Diabetes. The webinar’s seven speakers covered (1) advancements in insulin pump therapy, (2) efficacy of longer wear infusion sets, and (3) innovations to reduce plastics and insulin waste.
      Citation: Journal of Diabetes Science and Technology
      PubDate: 2022-03-01T06:36:50Z
      DOI: 10.1177/19322968221078884
       
  • Introducing the Continuous Glucose Data Analysis (CGDA) R Package: An
           Intuitive Package to Analyze Continuous Glucose Monitoring Data

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      Authors: Ilias Attaye, Eduard W. J. van der Vossen, Diogo N. Mendes Bastos, Max Nieuwdorp, Evgeni Levin
      First page: 783
      Abstract: Journal of Diabetes Science and Technology, Ahead of Print.

      Citation: Journal of Diabetes Science and Technology
      PubDate: 2022-01-19T10:49:16Z
      DOI: 10.1177/19322968211070293
       
  • Evaluation of the Accuracy and Reliability of a Tubeless Insulin Infusion
           System Under Laboratory Conditions

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      Authors: Jochen Mende, Manuel Eichenlaub, Delia Waldenmaier, Cornelia Haug, Guido Freckmann, Ralph Ziegler
      First page: 788
      Abstract: Journal of Diabetes Science and Technology, Ahead of Print.

      Citation: Journal of Diabetes Science and Technology
      PubDate: 2022-01-19T10:49:45Z
      DOI: 10.1177/19322968211070815
       
 
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