Journal of Diabetes Science and Technology最新文献

{"title":"Heat-Stable Insulins: Any Progress?","authors":"Lutz Heinemann","doi":"10.1177/19322968241305383","DOIUrl":"10.1177/19322968241305383","url":null,"abstract":"<p><p>Millions of people with diabetes have no or only limited access to electricity that limits their ability to store insulin according to the recommendations of the insulin manufacturer in general. At the same time, environmental temperatures are increasing in many countries which have a negative impact on the glucose-lowering effect of insulin not stored adequately. Therefore, the availability of heat-stable insulin formulations that do not require constant cooling would be of help for many patients; however, despite this clinical need, apparently not many are in clinical development. This commentary discusses the different aspects and approaches that are of relevance in this context.</p>","PeriodicalId":15475,"journal":{"name":"Journal of Diabetes Science and Technology","volume":" ","pages":"19322968241305383"},"PeriodicalIF":4.1,"publicationDate":"2024-12-13","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11638932/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142818255","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":"Utilizing a Novel Telemedicine Clinic for Managing Patients With Type 2 Diabetes: A Six-Month Randomized Control Trial Pilot Study.","authors":"Fiorella Sotomayor, Reynier Hernandez, Chikara Gothong, Monica Y Choe, Garrett I Ash, William Scott, Lillian Pinault, Fernando Gomez-Peralta, Marc R Blackman, Lakshmi G Singh, John D Sorkin, Elias K Spanakis","doi":"10.1177/19322968241305627","DOIUrl":"10.1177/19322968241305627","url":null,"abstract":"","PeriodicalId":15475,"journal":{"name":"Journal of Diabetes Science and Technology","volume":" ","pages":"19322968241305627"},"PeriodicalIF":4.1,"publicationDate":"2024-12-12","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11635784/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142812982","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":"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":"19322968241304779"},"PeriodicalIF":4.1,"publicationDate":"2024-12-10","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}

{"title":"Improvement in Newly Defined Continuous Glucose Monitor Metrics, Extended Hypoglycemia, and Extended Hyperglycemia With Automated Insulin Delivery Initiation in Adults With Type 1 Diabetes.","authors":"Kagan E Karakus, Janet Snell-Bergeon, Emma Mason, Halis K Akturk","doi":"10.1177/19322968241301429","DOIUrl":"10.1177/19322968241301429","url":null,"abstract":"<p><strong>Objective: </strong>Extended hypoglycemia (Ehypo) and extended hyperglycemia (Ehyper) are recently defined continuous glucose monitoring (CGM) metrics by the International Consensus for clinical trials as secondary endpoints for continuous outcomes. This study aims to evaluate the changes in Ehypo and Ehyper before and after automated insulin delivery (AID) initiation in adults with type 1 diabetes (T1D).</p><p><strong>Research methods: </strong>This is a retrospective single-center study that evaluated Ehypo and Ehyper in addition to other CGM metrics in 154 adults that initiated an AID system. Metrics were compared before and after AID initiation by Wilcoxon signed-rank test.</p><p><strong>Results: </strong>Median (interquartile range) Ehypo (<70 mg/dL) events/week decreased from 0.1 (0-0.4) to 0 (0-0.1) and Ehyper (>250 mg/dL) events/week decreased from 2.2 (0.9-4.5) to 0.8 (0.3-1.7) (both <i>P</i> < .001) after AID initiation compared with before AID initiation. All other CGM metrics improved after AID initiation. There was a strong positive correlation between Ehyper (>250 mg/dL) and mean glucose (before AID: <i>r</i> = 0.947, after AID: <i>r</i> = 0.894), glucose management indicator (before AID: <i>r</i> = 0.947, after AID: <i>r</i> = 0.887), and time above range (TAR; >180 mg/dL) (before AID: <i>r</i> = 0.957, after AID: <i>r</i> = 0.917) and a strong positive correlation between Ehypo (<70 mg/dL) and time below range (TBR; <70 mg/dL) (before AID: <i>r</i> = 0.823, after AID: <i>r</i> = 0.608) before and after AID initiation, respectively.</p><p><strong>Conclusion: </strong>Automated insulin delivery initiation significantly improved Ehypo and Ehyper metrics. Ehypo and Ehyper had a strong positive correlation with TBR and TAR, respectively. Ehypo and Ehyper events can be used in addition to TBR and TAR metrics in clinical studies as secondary outcomes.</p>","PeriodicalId":15475,"journal":{"name":"Journal of Diabetes Science and Technology","volume":" ","pages":"19322968241301429"},"PeriodicalIF":4.1,"publicationDate":"2024-12-05","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11618842/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142780241","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 DERMIS Study: Methodologies, Results, and Implications for the Future.","authors":"Irl B Hirsch, Dorrine Khakpour, Jeffrey Joseph, Michi M Shinohara, Ruikang K Wang, Ulrike Klueh, Donald Kreutzner, Jean-Pierre Riveline, Pauline Jacquemier, Lisa Maier, Michael T Longaker, Christopher G Parkin, Thomas Pieber, Andrea Kalus","doi":"10.1177/19322968241298005","DOIUrl":"10.1177/19322968241298005","url":null,"abstract":"<p><p>Ongoing innovation in diabetes technologies has led to the development of advanced tools such as automated insulin delivery (AID) systems that adjust insulin delivery in response to current and predicted glucose levels, residual insulin action, and other inputs (eg, meal and exercise announcements). However, infusion sets continue to be the \"Achilles heel\" of accurate and precise insulin delivery and continued device use. A recent study by Kalus et al (DERMIS Study) revealed higher vessel density and signals of inflammation by optical coherence tomography (OCT), in addition to increased inflammation, fat necrosis, fibrosis, and eosinophilic infiltration by histopathology. Although the study provided a comprehensive description of what was happening, the results raise important questions that require additional research. On February 29, 2024, the Leona M. and Harry B. Helmsley Charitable Trust sponsored a conference to begin addressing these issues. This article summarizes the DERMIS study findings and testing methodologies discussed at the conference and proposes the next steps for developing insulin infusion sets that reduce the variability in insulin delivery and extend wear.</p>","PeriodicalId":15475,"journal":{"name":"Journal of Diabetes Science and Technology","volume":" ","pages":"19322968241298005"},"PeriodicalIF":4.1,"publicationDate":"2024-12-05","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11618839/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142780247","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 User-Centered Design of a Clinical Dashboard and Patient-Facing App for Gestational Diabetes.","authors":"Jasmine R Kirkwood, Jane Dickson, Marryat Stevens, Areti Manataki, Robert S Lindsay, Deborah J Wake, Rebecca M Reynolds","doi":"10.1177/19322968241301792","DOIUrl":"10.1177/19322968241301792","url":null,"abstract":"<p><strong>Background: </strong>The number of pregnancies affected by gestational diabetes mellitus (GDM) is growing. With the increased use of smartphones and predictive modeling, a mobile health (mHealth) solution could be developed to improve care and management of GDM while streamlining care through risk stratification.</p><p><strong>Methods: </strong>A user-centered mHealth tool was designed from ethnographic observations and 11 semi-structured interviews (six health care professionals [HCPs] and five women with GDM), followed by iterative changes and evaluation from three feedback groups with 31 participants (17 HCPs, 14 researchers) and 13 questionnaires with women with GDM.</p><p><strong>Results: </strong>\"MyGDM\" includes a clinical dashboard that centralizes the clinic's patients, highlighting off-target blood glucose and predicting the need for pharmacological intervention. It is linked with a patient-facing app that includes structured education, culturally inclusive language options, and meal ideas. Through the feedback sessions, iterative changes were made around visualization and patient safety, and participants were positive toward the potential user experience. In the 13 questionnaires with women with GDM, 100% said it would fit into their lifestyle and help them manage GDM. Educational resources and the \"request a call\" functions were well received with 61.5% (8/13) and 69.2% (9/13) saying they were very likely or likely to use these, respectively.</p><p><strong>Conclusion: </strong>A user-centered mHealth tool consisting of a clinical dashboard linked with a patient-facing app for GDM care and management has been designed. Evaluation of the interactive design by end users was positive and showed that it met their needs.</p>","PeriodicalId":15475,"journal":{"name":"Journal of Diabetes Science and Technology","volume":" ","pages":"19322968241301792"},"PeriodicalIF":4.1,"publicationDate":"2024-11-29","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11607713/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142750374","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":"Improvement of Glycemia Risk Index and Continuous Glucose Monitoring Metrics During Ramadan Fasting in Type 1 Diabetes: A Real-World Observational Study.","authors":"Ayman Al Hayek, Mohamed A Al Dawish","doi":"10.1177/19322968241301750","DOIUrl":"10.1177/19322968241301750","url":null,"abstract":"<p><strong>Background: </strong>Managing glycemia during Ramadan is challenging for individuals with type 1 diabetes (T1D) due to prolonged fasting and altered eating patterns. While many are exempt from fasting, some choose to fast, necessitating careful monitoring. The glycemia risk index (GRI) is valuable for assessing glycemic quality and interpreting continuous glucose monitoring (CGM) data to identify individuals needing closer clinical attention. This study investigates the effects of Ramadan fasting on glycemic control in T1D, focusing on GRI and its components for hypoglycemia (CHypo) and hyperglycemia (CHyper).</p><p><strong>Method: </strong>An ambispective study involved 186 individuals with T1D using intermittent scanning CGM (isCGM). Data were retrospectively collected for one month before Ramadan and prospectively during and one month after Ramadan. Clinical, metabolic, and glycemic data were collected, with GRI calculated alongside its components.</p><p><strong>Results: </strong>During Ramadan, GRI improved by 54.6% (from 56.4 to 25.6), CHypo decreased by 60% (from 6 to 2.4), and CHyper dropped by 40.5% (from 21 to 12.5). However, these benefits were temporary, as glycemic measures increased after Ramadan, reflecting a return to pre-Ramadan patterns once normal routines resumed. No participants were admitted for diabetes emergencies during Ramadan. Adolescents and patients on insulin pumps had more favorable outcomes. GRI and its components significantly correlated with other CGM metrics, with these relationships maintained during and after Ramadan.</p><p><strong>Conclusions: </strong>Ramadan fasting significantly improved GRI and its components in individuals with T1D. Incorporating GRI as a novel metric alongside classical CGM metrics could enhance glycemic control, highlighting the need for personalized diabetes management strategies.</p>","PeriodicalId":15475,"journal":{"name":"Journal of Diabetes Science and Technology","volume":" ","pages":"19322968241301750"},"PeriodicalIF":4.1,"publicationDate":"2024-11-29","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11607719/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142754881","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 Application of Continuous Glucose Monitoring Endpoints in Clinical Research: Analysis of Trends and Review of Challenges.","authors":"Andrew Bevan, Graham Ellis, Mona Eskandarian, Davide Garrisi","doi":"10.1177/19322968241301800","DOIUrl":"10.1177/19322968241301800","url":null,"abstract":"<p><strong>Introduction: </strong>Considerable efforts to standardize continuous glucose monitoring (CGM) have occurred in recent years. The aim was to perform an analysis of clinical studies in clinicaltrials.gov to evaluate trends in CGM endpoint adoption.</p><p><strong>Methods: </strong>Clinicaltrials.gov was searched for studies of drugs, devices and combination products containing CGM terms posted from 2012 to 2023. 1269 studies were returned and 954 were excluded. 315 studies were divided into two periods (P1 [2012-2017] and P2 [2018-2023]) and differences analyzed using descriptive statistics and two-tailed <i>t</i> tests.</p><p><strong>Results: </strong>There was a significant 60.3% increase in total clinical studies from P1 (121) to P2 (194). Phase 2 and Phase 3 Studies both saw significant increases of 125.8 and 169.2%, respectively, in P2. Adult-only studies predominated in both periods, with a 40.4% increase in P2. Studies that included pediatric populations, although smaller in number, increased significantly. Most studies were nonindustry-funded, and studies in this category saw a significant 80.0% increase in P2. However, industry-only funded studies also increased significantly by 78.4% in P2 in the same period. Studies of type 1 diabetes (T1DM) and type 2 diabetes (T2DM) increased by 55.8% and 26.9%, respectively, but increases were not statistically significant. Studies of nondiabetes-related indications did increase significantly (233.3%). 27.6% of studies used CGM-derived metrics as primary endpoints (PE). Studies that used time in range (TIR) increased by 222.4% in P2, which was significant. Conversely studies that used mean amplitude of glycemic excursions (MAGE) decreased significantly by 71.3%.</p><p><strong>Conclusion: </strong>Our data provide evidence of significant increases in the application of CGM endpoints in clinical studies in the last six years, including studies with TIR as the PE. Increases have been driven largely by academia, but our data show that industry is starting to follow suit. The significant increase in studies that included pediatrics is encouraging.</p>","PeriodicalId":15475,"journal":{"name":"Journal of Diabetes Science and Technology","volume":" ","pages":"19322968241301800"},"PeriodicalIF":4.1,"publicationDate":"2024-11-28","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11603422/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142739721","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":"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":"19322968241302349"},"PeriodicalIF":4.1,"publicationDate":"2024-11-25","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":"Is Continuous Glucose Monitoring Feasible in Tribal India? Navigating the Benefits and Overcoming the Challenges.","authors":"Kritika Singh, Tapas Chakma, Aayushi Nagwanshi, Suyesh Shrivastava","doi":"10.1177/19322968241302056","DOIUrl":"10.1177/19322968241302056","url":null,"abstract":"","PeriodicalId":15475,"journal":{"name":"Journal of Diabetes Science and Technology","volume":" ","pages":"19322968241302056"},"PeriodicalIF":4.1,"publicationDate":"2024-11-22","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11585006/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142693024","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}