Francesco Giorgino, Tadej Battelino, Richard M Bergenstal, Thomas Forst, Jennifer B Green, Chantal Mathieu, Helena W Rodbard, Oliver Schnell, Emma G Wilmot
{"title":"The Role of Ultra-Rapid-Acting Insulin Analogs in Diabetes: An Expert Consensus.","authors":"Francesco Giorgino, Tadej Battelino, Richard M Bergenstal, Thomas Forst, Jennifer B Green, Chantal Mathieu, Helena W Rodbard, Oliver Schnell, Emma G Wilmot","doi":"10.1177/19322968231204584","DOIUrl":"10.1177/19322968231204584","url":null,"abstract":"<p><p>Ultra-rapid-acting insulin analogs (URAA) are a further development and refinement of rapid-acting insulin analogs. Because of their adapted formulation, URAA provide an even faster pharmacokinetics and thus an accelerated onset of insulin action than conventional rapid-acting insulin analogs, allowing for a more physiologic delivery of exogenously applied insulin. Clinical trials have confirmed the superiority of URAA in controlling postprandial glucose excursions, with a safety profile that is comparable to the rapid-acting insulins. Consequently, many individuals with diabetes mellitus may benefit from URAA in terms of prandial glycemic control. Unfortunately, there are only few available recommendations from authoritative sources for use of URAA in clinical practice. Therefore, this expert consensus report aims to define populations of people with diabetes mellitus for whom URAA may be beneficial and to provide health care professionals with concrete, practical recommendations on how best to use URAA in this context.</p>","PeriodicalId":15475,"journal":{"name":"Journal of Diabetes Science and Technology","volume":" ","pages":"452-469"},"PeriodicalIF":4.1,"publicationDate":"2025-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11874134/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"71482121","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Cindy N Ho, Alessandra T Ayers, Rachel E Aaron, Tiffany Tian, Chin-Sean Sum, David C Klonoff
{"title":"Importance of Cybersecurity/The Relevance of Cybersecurity to Diabetes Devices: An Update from Diabetes Technology Society.","authors":"Cindy N Ho, Alessandra T Ayers, Rachel E Aaron, Tiffany Tian, Chin-Sean Sum, David C Klonoff","doi":"10.1177/19322968241296543","DOIUrl":"10.1177/19322968241296543","url":null,"abstract":"<p><p>As medical devices become more integrated with wireless technologies, the risks of cyberattacks and data breaches increase, making stringent cybersecurity measures essential. The implementation of rigorous cybersecurity standards is essential for enhancing the cybersecurity of devices. This article examines the evolving cyber threats faced by the medical technology industry, the role of IEEE 2621 in providing comprehensive security benchmarks for medical devices, and the need for continuous risk assessments and adherence to regulatory standards to mitigate future cyber risks. Adherence to cybersecurity standards establishes ensures the effective protection of sensitive data and critical infrastructure.</p>","PeriodicalId":15475,"journal":{"name":"Journal of Diabetes Science and Technology","volume":" ","pages":"470-474"},"PeriodicalIF":4.1,"publicationDate":"2025-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11571616/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142604946","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Jordan Christie, Mark A Clements, David D Williams, Joseph Cernich, Susana R Patton
{"title":"Mealtime Insulin BOLUS Score More Strongly Predicts HbA1c Than the Self-Care Inventory in Youth With Type 1 Diabetes.","authors":"Jordan Christie, Mark A Clements, David D Williams, Joseph Cernich, Susana R Patton","doi":"10.1177/19322968231192979","DOIUrl":"10.1177/19322968231192979","url":null,"abstract":"<p><strong>Background: </strong>To meet their glycated hemoglobin (HbA1c) goals, youth with type 1 diabetes (T1D) need to engage with their daily T1D treatment. The mealtime insulin Bolus score (BOLUS) is an objective measure of youth's T1D engagement which we have previously shown to be superior to other objective engagement measures in predicting youth's HbA1c. Here, to further assess the BOLUS score's validity, we compared the strengths of the associations between youth's HbA1c with their mean insulin BOLUS score and a valid, self-report measure of T1D engagement, the Self-Care Inventory (SCI).</p><p><strong>Methods: </strong>One-hundred and five youth with T1D self-reported their T1D engagement using the SCI. We also collected two weeks of insulin pump data and a concurrent HbA1c level. We scored youth's SCI and calculated their mean insulin BOLUS score using standardized methods. For the analyses, we performed simple correlations, partial correlations, and multiple regression models.</p><p><strong>Results: </strong>Youth had a mean age of 15.03 ± 1.97 years, mean time since diagnosis of 8.11 ± 3.26 years, and a mean HbA1c of 8.78 ± 1.49%. The sample included n = 58 boys (55%) and n = 96 families (91%) self-identified as white. Simple correlations between youth's age, HbA1c, SCI total score, and BOLUS score were all significant. Partial correlation and regression models revealed that youth's insulin BOLUS score was more strongly associated with HbA1c than the SCI.</p><p><strong>Conclusions: </strong>Youths' BOLUS score has better concurrent validity with HbA1c than the SCI. We should consider reporting the BOLUS score as an outcome metric in insulin pump data reports.</p>","PeriodicalId":15475,"journal":{"name":"Journal of Diabetes Science and Technology","volume":" ","pages":"340-344"},"PeriodicalIF":4.1,"publicationDate":"2025-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11873986/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"10332767","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Andreas Pfützner, Daiva Kalasauske, Mina Hanna, Daniela Sachsenheimer, Gerhard Raab, Silvia Weissenbacher, Nicole Thomé
{"title":"System Accuracy and Interference Evaluation of a New Glucose Dehydrogenase-Based Blood Glucose Meter for Patient Self-Testing.","authors":"Andreas Pfützner, Daiva Kalasauske, Mina Hanna, Daniela Sachsenheimer, Gerhard Raab, Silvia Weissenbacher, Nicole Thomé","doi":"10.1177/19322968231201862","DOIUrl":"10.1177/19322968231201862","url":null,"abstract":"<p><p>New European medical device regulations require the performance of postmarketing surveillance evaluations for blood glucose meters (BGMs). We conducted an ISO15197:2015-conform system performance evaluation with the approved glucose dehydrogenase (GDH)-based Wellion NEWTON BGM. One hundred subjects were enrolled into the study (44 female, 56 male, 43 healthy subjects, 23 type 1 diabetes, 34 type 2 diabetes, age: 53.7 ± 15.8 years). In addition, manipulated heparinized whole blood was used for a laboratory interference test with ten selected substances (interference definition: substance-induced bias > 10%). The mean absolute relative difference (MARD) was 4.7%, and 100% of the values were in zones A (99.7%) and B (0.3%), respectively, of the consensus error grid. Interference was observed with xylose only, which is a known interfering substance for GDH-based BGMs.</p>","PeriodicalId":15475,"journal":{"name":"Journal of Diabetes Science and Technology","volume":" ","pages":"431-435"},"PeriodicalIF":4.1,"publicationDate":"2025-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11874304/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"41139763","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Halis K Akturk, Kagan E Karakus, Edwin D'Souza, Kimia Z Assadi, Jordan E Pinsker, Laurel H Messer
{"title":"Glycemic and Patient-Reported Outcomes for Users of a New, Compact Automated Insulin Delivery System: A First Report.","authors":"Halis K Akturk, Kagan E Karakus, Edwin D'Souza, Kimia Z Assadi, Jordan E Pinsker, Laurel H Messer","doi":"10.1177/19322968241302349","DOIUrl":"10.1177/19322968241302349","url":null,"abstract":"","PeriodicalId":15475,"journal":{"name":"Journal of Diabetes Science and Technology","volume":" ","pages":"582-583"},"PeriodicalIF":4.1,"publicationDate":"2025-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11590071/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142716357","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"Pitfalls and Challenges for Diabetes Technology Start-Ups.","authors":"Derek Brandt, Craig Cooper, Lutz Heinemann","doi":"10.1177/19322968241233606","DOIUrl":"10.1177/19322968241233606","url":null,"abstract":"","PeriodicalId":15475,"journal":{"name":"Journal of Diabetes Science and Technology","volume":" ","pages":"283-285"},"PeriodicalIF":4.1,"publicationDate":"2025-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11571704/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"139912739","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Clara Furió-Novejarque, José-Luis Díez, Jorge Bondia
{"title":"GLP-1 Receptor Agonists Models for Type 1 Diabetes: A Narrative Review.","authors":"Clara Furió-Novejarque, José-Luis Díez, Jorge Bondia","doi":"10.1177/19322968241285925","DOIUrl":"10.1177/19322968241285925","url":null,"abstract":"<p><strong>Background: </strong>Glucagon-like peptide 1 (GLP-1) is a hormone that promotes insulin secretion, delays gastric emptying, and inhibits glucagon secretion. The GLP-1 receptor agonists have been developed as adjunctive therapies for type 2 diabetes to improve glucose control. Recently, there has been an interest in introducing GLP-1 receptor agonists as adjunctive therapies in type 1 diabetes alongside automatic insulin delivery systems. The preclinical validation of these systems often relies on mathematical simulators that replicate the glucose dynamics of a person with diabetes. This review aims to explore mathematical models available in the literature to describe GLP-1 effects to be used in a type 1 diabetes simulator.</p><p><strong>Methods: </strong>Three databases were examined in the search for GLP-1 mathematical models. More than 1500 works were found after searching for specific keywords that were narrowed down to 39 works for full-text assessment.</p><p><strong>Results: </strong>A total of 23 works were selected describing GLP-1 pharmacokinetics and pharmacodynamics. However, none of the found models was designed for type 1 diabetes. An analysis is included of the available models' features that could be translated into a GLP-1 receptor agonist model for type 1 diabetes.</p><p><strong>Conclusion: </strong>There is a gap in research in GLP-1 receptor agonists mathematical models for type 1 diabetes, which could be incorporated into type 1 diabetes simulators, providing a safe and inexpensive tool to carry out preclinical validations using these therapies.</p>","PeriodicalId":15475,"journal":{"name":"Journal of Diabetes Science and Technology","volume":" ","pages":"332-339"},"PeriodicalIF":4.1,"publicationDate":"2025-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11571630/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142466694","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"The Promise of Adjunct Medications in Improving Type 1 Diabetes Outcomes: Glucagon-Like Peptide Receptor Agonists.","authors":"Sujatha Seetharaman, Eda Cengiz","doi":"10.1177/19322968241309896","DOIUrl":"10.1177/19322968241309896","url":null,"abstract":"<p><p>Type 1 diabetes (T1D) necessitates lifelong insulin therapy due to the autoimmune destruction of insulin-producing pancreatic beta cells. Despite advancements in diabetes technology and insulin formulations, maintaining optimal glycemic outcomes remains challenging in these individuals. Obesity, accompanied by insulin resistance, is common not only in type 2 diabetes (T2D) but also in many individuals with T1D. Glucagon-like peptide-1 receptor agonists (GLP-1 RAs), approved for T2D and obesity, are now being explored for off-label use in individuals with T1D. This review examines their efficacy, safety, and potential benefits in T1D management. We reviewed articles published up to May 2024 from databases like PubMed and Scopus, mainly focusing on human studies of GLP-1 RAs in T1D, as well as cardiorenal and metabolic outcomes in individuals with T2D and obesity. Semaglutide and other GLP-1 RAs showed significant improvements in glycemic outcomes, hemoglobin A<sub>1c</sub> levels, reduced insulin doses, and notable weight loss. Studies in individuals with obesity and T2D showed significant improvements in lipid profile and offered cardiorenal protection. Common side effects include gastrointestinal issues, and while some studies reported hypoglycemia, hyperglycemia, and ketosis, others did not. Despite these challenges, GLP-1 RAs offer significant therapeutic benefits, making them a promising adjunct to insulin therapy for improving clinical outcomes in T1D management.</p>","PeriodicalId":15475,"journal":{"name":"Journal of Diabetes Science and Technology","volume":"19 2","pages":"311-320"},"PeriodicalIF":4.1,"publicationDate":"2025-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11686489/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143531516","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Julie Maria Bøggild Brøsen, Rikke Mette Agesen, Amra Ciric Alibegovic, Henrik Ullits Andersen, Henning Beck-Nielsen, Peter Gustenhoff, Troels Krarup Hansen, Christoffer Hedetoft, Tonny Joran Jensen, Claus Bogh Juhl, Charlotte Røn Stolberg, Susanne Søgaard Lerche, Kirsten Nørgaard, Hans-Henrik Parving, Lise Tarnow, Birger Thorsteinsson, Ulrik Pedersen-Bjergaard
{"title":"The Effect of Insulin Degludec Versus Insulin Glargine U100 on Glucose Metrics Recorded During Continuous Glucose Monitoring in People With Type 1 Diabetes and Recurrent Nocturnal Severe Hypoglycemia.","authors":"Julie Maria Bøggild Brøsen, Rikke Mette Agesen, Amra Ciric Alibegovic, Henrik Ullits Andersen, Henning Beck-Nielsen, Peter Gustenhoff, Troels Krarup Hansen, Christoffer Hedetoft, Tonny Joran Jensen, Claus Bogh Juhl, Charlotte Røn Stolberg, Susanne Søgaard Lerche, Kirsten Nørgaard, Hans-Henrik Parving, Lise Tarnow, Birger Thorsteinsson, Ulrik Pedersen-Bjergaard","doi":"10.1177/19322968231197423","DOIUrl":"10.1177/19322968231197423","url":null,"abstract":"<p><strong>Aim: </strong>Comparing continuous glucose monitoring (CGM)-recorded metrics during treatment with insulin degludec (IDeg) versus insulin glargine U100 (IGlar-100) in people with type 1 diabetes (T1D) and recurrent nocturnal severe hypoglycemia.</p><p><strong>Materials and methods: </strong>This is a multicenter, two-year, randomized, crossover trial, including 149 adults with T1D and minimum one episode of nocturnal severe hypoglycemia within the last two years. Participants were randomized 1:1 to treatment with IDeg or IGlar-100 and given the option of six days of blinded CGM twice during each treatment. CGM traces were reviewed for the percentage of time-within-target glucose range (TIR), time-below-range (TBR), time-above-range (TAR), and coefficient of variation (CV).</p><p><strong>Results: </strong>Seventy-four participants were included in the analysis. Differences between treatments were greatest during the night (23:00-06:59). Treatment with IGlar-100 resulted in 54.0% vs 49.0% with IDeg TIR (70-180 mg/dL) (estimated treatment difference [ETD]: -4.6%, 95% confidence interval [CI]: -9.1, -0.0, <i>P</i> = .049). TBR was lower with IDeg at level 1 (54-69 mg/dL) (ETD: -1.7% [95% CI: -2.9, -0.5], <i>P</i> < .05) and level 2 (<54 mg/dL) (ETD: -1.3% [95% CI: -2.1, -0.5], <i>P</i> = .001). TAR was higher with IDeg compared with IGlar-100 at level 1 (181-250 mg/dL) (ETD: 4.0% [95% CI: 0.8, 7.3], P < .05) and level 2 (> 250 mg/dL) (ETD: 4.0% [95% CI: 0.8, 7.2], <i>P</i> < .05). The mean CV was lower with IDeg than that with IGlar-100 (ETD: -3.4% [95% CI: -5.6, -1.2], <i>P</i> < .05).</p><p><strong>Conclusion: </strong>For people with T1D suffering from recurrent nocturnal severe hypoglycemia, treatment with IDeg, compared with IGlar-100, results in a lower TBR and CV during the night at the expense of more TAR.</p>","PeriodicalId":15475,"journal":{"name":"Journal of Diabetes Science and Technology","volume":" ","pages":"390-399"},"PeriodicalIF":4.1,"publicationDate":"2025-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11874210/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"10159771","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Sharon Orrange, Tess Humphrey, Ethan Fayne, Anne Peters
{"title":"Semaglutide for Weight Reduction in Type 1 Diabetes: Promising Results With Uncertain Glycemic Impact.","authors":"Sharon Orrange, Tess Humphrey, Ethan Fayne, Anne Peters","doi":"10.1177/19322968241304779","DOIUrl":"10.1177/19322968241304779","url":null,"abstract":"","PeriodicalId":15475,"journal":{"name":"Journal of Diabetes Science and Technology","volume":" ","pages":"593-594"},"PeriodicalIF":4.1,"publicationDate":"2025-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11629341/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142801037","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}