Pub Date : 2025-12-24DOI: 10.1007/s13300-025-01834-4
Sheryl S Salis, Ami Sanghvi, Natasha Vora, Shefa Syed, Priya Karkera, Pushkala Padmanabh, Mirian Lansink, Mia Isabelle, Samrin Khan, Riya Gaglani, Sharvari R Desai, Apurva A Halbe, S A Udipi
Introduction: Traditional Indian cereal-based breakfast items have high glycemic index (GI) contributing to postprandial (PP) glucose spikes. Use of diabetes-specific protein supplement (DSPS) may reduce glycemic excursions. The study aimed to evaluate the effect of partially replacing breakfast with DSPS (Protinex Diabetes Care) on PP glycemic response.
Methods: Forty-two persons with type 2 diabetes mellitus (T2DM) participated in this randomized, controlled, open-label, crossover study. Participants consumed a test breakfast (DSPS in 200 ml milk + reduced portion of popular Indian savory breakfast (upma/poha)) or isocaloric control breakfast (upma/poha) for 5 days, with 3-day washout. PP glucose and insulin were assessed on the first day of intervention at baseline, 30, 60, 90, 120, 150, and 180 min after breakfast to calculate incremental area under the curve (iAUC0-3h) and delta peak (ΔCmax). During in-home use, macronutrient intake was assessed using dietary recalls, and glycemic variability (GV) was assessed using continuous glucose monitoring (CGM).
Results: Glucose iAUC0-3h and ΔCmax were 59% and 46% lower in test vs control, respectively. Insulin iAUC0-3h and ΔCmax did not differ significantly. During the test period, protein intake was significantly higher by 8.8 g; mean amplitude of glycemic excursions (MAGE)-a GV metric-was significantly lower. There were no gastrointestinal or adverse events. DSPS was well accepted by participants.
Conclusions: DSPS as a partial breakfast replacement improves blood glucose control without significantly impacting insulin response. In a real-world setting, DSPS enhances protein intake and reduces GV. These findings support DSPS as a practical, well-tolerated strategy for improving glycemic control and macronutrient intake balance in people with T2DM.
Trial registration: The trial was registered with Clinical Trials Registry India (CTRI) CTRI/2024/08/072006 and has been registered in the International Clinical Trials Registry Platform (ICTRP).
{"title":"Effect of a Diabetes-Specific Protein Supplement (DSPS) on Postprandial Glycemic Responses in Adults with Type 2 Diabetes: A Randomized Crossover Study in India.","authors":"Sheryl S Salis, Ami Sanghvi, Natasha Vora, Shefa Syed, Priya Karkera, Pushkala Padmanabh, Mirian Lansink, Mia Isabelle, Samrin Khan, Riya Gaglani, Sharvari R Desai, Apurva A Halbe, S A Udipi","doi":"10.1007/s13300-025-01834-4","DOIUrl":"https://doi.org/10.1007/s13300-025-01834-4","url":null,"abstract":"<p><strong>Introduction: </strong>Traditional Indian cereal-based breakfast items have high glycemic index (GI) contributing to postprandial (PP) glucose spikes. Use of diabetes-specific protein supplement (DSPS) may reduce glycemic excursions. The study aimed to evaluate the effect of partially replacing breakfast with DSPS (Protinex Diabetes Care) on PP glycemic response.</p><p><strong>Methods: </strong>Forty-two persons with type 2 diabetes mellitus (T2DM) participated in this randomized, controlled, open-label, crossover study. Participants consumed a test breakfast (DSPS in 200 ml milk + reduced portion of popular Indian savory breakfast (upma/poha)) or isocaloric control breakfast (upma/poha) for 5 days, with 3-day washout. PP glucose and insulin were assessed on the first day of intervention at baseline, 30, 60, 90, 120, 150, and 180 min after breakfast to calculate incremental area under the curve (iAUC0-3h) and delta peak (ΔCmax). During in-home use, macronutrient intake was assessed using dietary recalls, and glycemic variability (GV) was assessed using continuous glucose monitoring (CGM).</p><p><strong>Results: </strong>Glucose iAUC0-3h and ΔCmax were 59% and 46% lower in test vs control, respectively. Insulin iAUC0-3h and ΔCmax did not differ significantly. During the test period, protein intake was significantly higher by 8.8 g; mean amplitude of glycemic excursions (MAGE)-a GV metric-was significantly lower. There were no gastrointestinal or adverse events. DSPS was well accepted by participants.</p><p><strong>Conclusions: </strong>DSPS as a partial breakfast replacement improves blood glucose control without significantly impacting insulin response. In a real-world setting, DSPS enhances protein intake and reduces GV. These findings support DSPS as a practical, well-tolerated strategy for improving glycemic control and macronutrient intake balance in people with T2DM.</p><p><strong>Trial registration: </strong>The trial was registered with Clinical Trials Registry India (CTRI) CTRI/2024/08/072006 and has been registered in the International Clinical Trials Registry Platform (ICTRP).</p>","PeriodicalId":11192,"journal":{"name":"Diabetes Therapy","volume":" ","pages":""},"PeriodicalIF":2.6,"publicationDate":"2025-12-24","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145817994","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2025-12-19DOI: 10.1007/s13300-025-01830-8
Heejun Son, Sun-Joon Moon, Young Min Cho
Continuous glucose monitoring (CGM) has transformed diabetes management by providing continuous, high-resolution insight into glucose dynamics. Initially developed for type 1 diabetes, CGM now demonstrates substantial clinical and behavioral benefits for individuals with type 2 diabetes across diverse therapeutic settings. This narrative review synthesizes current evidence on the expanding role of CGM in optimizing glycemic control and promoting patient-driven lifestyle modification.Across randomized and real-world studies, CGM consistently improves glycosylated hemoglobin, increases time in range, and reduces glycemic variability, regardless of insulin use. Beyond metabolic outcomes, CGM enhances treatment satisfaction, psychological well-being, and self-efficacy, particularly when combined with structured education and feedback. By enabling individuals to visualize real-time glucose responses to daily behaviors, CGM serves as a powerful catalyst for sustained behavioral change and personalized self-management.In addition to its therapeutic applications, CGM also provides diagnostic insight by revealing unrecognized glucose excursions that conventional monitoring may miss, facilitating earlier identification of dysglycemia in at-risk individuals. Yet significant barriers persist, including device costs, limited insurance coverage, and the difficulty of translating raw data into actionable insights for patients and clinicians.In conclusion, CGM has evolved from a glucose-monitoring device to a comprehensive platform that supports both clinical decision-making and behavioral empowerment, bridging the continuum from diabetes prevention to long-term management.
{"title":"The Expanding Role of Continuous Glucose Monitoring in the Management and Prevention of Type 2 Diabetes.","authors":"Heejun Son, Sun-Joon Moon, Young Min Cho","doi":"10.1007/s13300-025-01830-8","DOIUrl":"https://doi.org/10.1007/s13300-025-01830-8","url":null,"abstract":"<p><p>Continuous glucose monitoring (CGM) has transformed diabetes management by providing continuous, high-resolution insight into glucose dynamics. Initially developed for type 1 diabetes, CGM now demonstrates substantial clinical and behavioral benefits for individuals with type 2 diabetes across diverse therapeutic settings. This narrative review synthesizes current evidence on the expanding role of CGM in optimizing glycemic control and promoting patient-driven lifestyle modification.Across randomized and real-world studies, CGM consistently improves glycosylated hemoglobin, increases time in range, and reduces glycemic variability, regardless of insulin use. Beyond metabolic outcomes, CGM enhances treatment satisfaction, psychological well-being, and self-efficacy, particularly when combined with structured education and feedback. By enabling individuals to visualize real-time glucose responses to daily behaviors, CGM serves as a powerful catalyst for sustained behavioral change and personalized self-management.In addition to its therapeutic applications, CGM also provides diagnostic insight by revealing unrecognized glucose excursions that conventional monitoring may miss, facilitating earlier identification of dysglycemia in at-risk individuals. Yet significant barriers persist, including device costs, limited insurance coverage, and the difficulty of translating raw data into actionable insights for patients and clinicians.In conclusion, CGM has evolved from a glucose-monitoring device to a comprehensive platform that supports both clinical decision-making and behavioral empowerment, bridging the continuum from diabetes prevention to long-term management.</p>","PeriodicalId":11192,"journal":{"name":"Diabetes Therapy","volume":" ","pages":""},"PeriodicalIF":2.6,"publicationDate":"2025-12-19","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145780384","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2025-12-11DOI: 10.1007/s13300-025-01824-6
Mohamed Hassanein, Thamer Alessa, Khadija A Hafidh, Lamya Alzubaidi, Mahir Jallo, Fatma Al Slail, Hussein Elbadawi, Rayaz A Malik
Sequential addition of oral glucose-lowering therapies, insulin or incretin-based therapy is often required to attain optimal glycemic control and reduce the risk of diabetes-associated complications. Despite advances in treatment, a large proportion of people with type 2 diabetes fail to achieve optimal glycemic control. Recent guidelines emphasize the need to commence injectable options in individuals unable to attain glycemic targets, despite maximal oral therapy. In individuals already on basal insulin, an improvement in glycemic control requires stepwise addition of prandial insulin, full basal-bolus insulin regimen, or additional injectable incretin-based therapy. However, concerns around weight gain and hypoglycemia often limit addition or increase in insulin to improve glycemic control. Treatment simplification i.e. a decrease in treatment complexity, particularly insulin therapy, seeks to alleviate treatment burden without compromising therapeutic efficacy and safety. However, currently there is a lack of guidance on simplifying treatment, particularly for individuals unable to attain glycemic targets. We now provide evidence-based treatment simplification strategies for people with diabetes in the Gulf Cooperation Council region.
{"title":"Use of Fixed Ratio Combinations to Improve Glycemic Control in Individuals with Type 2 Diabetes: Experts' Opinion from the Gulf Region.","authors":"Mohamed Hassanein, Thamer Alessa, Khadija A Hafidh, Lamya Alzubaidi, Mahir Jallo, Fatma Al Slail, Hussein Elbadawi, Rayaz A Malik","doi":"10.1007/s13300-025-01824-6","DOIUrl":"https://doi.org/10.1007/s13300-025-01824-6","url":null,"abstract":"<p><p>Sequential addition of oral glucose-lowering therapies, insulin or incretin-based therapy is often required to attain optimal glycemic control and reduce the risk of diabetes-associated complications. Despite advances in treatment, a large proportion of people with type 2 diabetes fail to achieve optimal glycemic control. Recent guidelines emphasize the need to commence injectable options in individuals unable to attain glycemic targets, despite maximal oral therapy. In individuals already on basal insulin, an improvement in glycemic control requires stepwise addition of prandial insulin, full basal-bolus insulin regimen, or additional injectable incretin-based therapy. However, concerns around weight gain and hypoglycemia often limit addition or increase in insulin to improve glycemic control. Treatment simplification i.e. a decrease in treatment complexity, particularly insulin therapy, seeks to alleviate treatment burden without compromising therapeutic efficacy and safety. However, currently there is a lack of guidance on simplifying treatment, particularly for individuals unable to attain glycemic targets. We now provide evidence-based treatment simplification strategies for people with diabetes in the Gulf Cooperation Council region.</p>","PeriodicalId":11192,"journal":{"name":"Diabetes Therapy","volume":" ","pages":""},"PeriodicalIF":2.6,"publicationDate":"2025-12-11","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145721518","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2025-12-09DOI: 10.1007/s13300-025-01825-5
Catherine B Johannes, Craig I Coleman, Csaba P Kovesdy, Anam M Khan, Ryan Ziemiecki, J Bradley Layton, David Vizcaya, Fangfang Liu, Nikolaus G Oberprieler
Introduction: Type 2 diabetes is a leading cause of chronic kidney disease (CKD). Individuals with both conditions have increased risk of poor cardiorenal outcomes and mortality. The rapidly evolving landscape for CKD-protective therapies in type 2 diabetes currently includes sodium-glucose cotransporter 2 inhibitors (SGLT2i) and glucagon-like peptide-1 receptor agonists (GLP-1 RA), both of which demonstrate cardiorenal outcome benefits. As part of the FOUNTAIN platform (ClinicalTrials.gov ID: NCT05526157; EUPAS ID: EUPAS48148), this study aimed to better understand changes in patient characteristics and treatment patterns corresponding with updates to clinical guideline recommendations and drug labeling and the emergence of new CKD-protective therapies such as finerenone in the US in 2021-2022.
Methods: An observational real-world data study assessed patient characteristics and drug utilization in separate SGLT2i and GLP-1 RA new-user cohorts of adults with CKD and type 2 diabetes in an earlier (1 January 2012-30 June 2021) and a later (9 July 2021-30 September 2023) period using Optum's de-identified Clinformatics® Data Mart Database (Optum® CDM).
Results: Compared with the earlier period new users, later period new users in both cohorts were older, had more severe CKD, used less intensive type 2 diabetes medication, and had better metabolic control; SGLT2i new users more frequently had no type 2 diabetes therapy before the index date and greater congestive heart failure prevalence; and GLP-1 RA new users had increased SGLT2i use and decreased insulin use.
Conclusions: These findings inform and contextualize future studies assessing cardiorenal outcomes for these and additional treatments, including finerenone, for individuals with CKD and type 2 diabetes.
{"title":"Temporal Changes in SGLT2 Inhibitor and GLP-1 Receptor Agonist Use in Patients with Chronic Kidney Disease and Type 2 Diabetes, 2012-2023: A US Cohort Study.","authors":"Catherine B Johannes, Craig I Coleman, Csaba P Kovesdy, Anam M Khan, Ryan Ziemiecki, J Bradley Layton, David Vizcaya, Fangfang Liu, Nikolaus G Oberprieler","doi":"10.1007/s13300-025-01825-5","DOIUrl":"https://doi.org/10.1007/s13300-025-01825-5","url":null,"abstract":"<p><strong>Introduction: </strong>Type 2 diabetes is a leading cause of chronic kidney disease (CKD). Individuals with both conditions have increased risk of poor cardiorenal outcomes and mortality. The rapidly evolving landscape for CKD-protective therapies in type 2 diabetes currently includes sodium-glucose cotransporter 2 inhibitors (SGLT2i) and glucagon-like peptide-1 receptor agonists (GLP-1 RA), both of which demonstrate cardiorenal outcome benefits. As part of the FOUNTAIN platform (ClinicalTrials.gov ID: NCT05526157; EUPAS ID: EUPAS48148), this study aimed to better understand changes in patient characteristics and treatment patterns corresponding with updates to clinical guideline recommendations and drug labeling and the emergence of new CKD-protective therapies such as finerenone in the US in 2021-2022.</p><p><strong>Methods: </strong>An observational real-world data study assessed patient characteristics and drug utilization in separate SGLT2i and GLP-1 RA new-user cohorts of adults with CKD and type 2 diabetes in an earlier (1 January 2012-30 June 2021) and a later (9 July 2021-30 September 2023) period using Optum's de-identified Clinformatics<sup>®</sup> Data Mart Database (Optum<sup>®</sup> CDM).</p><p><strong>Results: </strong>Compared with the earlier period new users, later period new users in both cohorts were older, had more severe CKD, used less intensive type 2 diabetes medication, and had better metabolic control; SGLT2i new users more frequently had no type 2 diabetes therapy before the index date and greater congestive heart failure prevalence; and GLP-1 RA new users had increased SGLT2i use and decreased insulin use.</p><p><strong>Conclusions: </strong>These findings inform and contextualize future studies assessing cardiorenal outcomes for these and additional treatments, including finerenone, for individuals with CKD and type 2 diabetes.</p>","PeriodicalId":11192,"journal":{"name":"Diabetes Therapy","volume":" ","pages":""},"PeriodicalIF":2.6,"publicationDate":"2025-12-09","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145707809","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2025-12-01Epub Date: 2025-11-01DOI: 10.1007/s13300-025-01819-3
So Ra Kim, Minyoung Lee, Yong-Ho Lee, Eun Seok Kang, Bong-Soo Cha, Byung-Wan Lee
Introduction: β-Hydroxybutyrate (βHB), the most stable form of ketone bodies, has exhibited protective effects in metabolic and chronic diseases. This study aimed to assess the association between fasting serum βHB levels, measured at baseline in drug-naïve state, and the risk of proteinuria in patients with newly diagnosed type 2 diabetes.
Methods: In this longitudinal study involving 280 patients, baseline fasting serum βHB levels, urine protein parameters, and metabolic parameters were evaluated. To monitor the development of albuminuria (spot urine albumin-to-creatinine ratio ≥ 30.0 mg/gCr) or proteinuria (spot urine protein-to-creatinine ratio > 0.15 g/gCr), patients with normal baseline levels were followed for a mean of 2.40 ± 1.40 years.
Results: Patients were classified into the highest tertile of baseline serum βHB level group and two other lower tertiles. The highest tertile group (median fasting serum βHB: 0.30 mmol/l) had a significantly lower incidence of proteinuria (6.90% vs. 24.3%, p = 0.028) and nonalbumin proteinuria (6.67% vs. 22.9%, p = 0.031) compared to the lower two tertiles. Higher baseline βHB levels were associated with a reduced risk of proteinuria (hazard ratio 0.313, 95% confidence interval 0.110-0.891), adjusted for confounders.
Conclusion: Higher baseline fasting serum βHB levels are linked to a lower risk of proteinuria in newly diagnosed type 2 diabetes, suggesting its potential as a protective metabolic marker in early diabetic kidney disease.
简介:β-羟基丁酸(βHB)是最稳定的酮体形式,在代谢和慢性疾病中显示出保护作用。本研究旨在评估空腹血清βHB水平(在drug-naïve状态下基线测量)与新诊断的2型糖尿病患者蛋白尿风险之间的关系。方法:在这项涉及280例患者的纵向研究中,评估了基线空腹血清βHB水平、尿蛋白参数和代谢参数。为了监测蛋白尿(尿白蛋白与肌酐比值≥30.0 mg/gCr)或蛋白尿(尿白蛋白与肌酐比值> 0.15 g/gCr)的发展,对基线水平正常的患者进行平均2.40±1.40年的随访。结果:将患者分为血清βHB基线水平最高的组和2个较低的组。与低两组相比,高五分位数组(空腹血清βHB中位数:0.30 mmol/l)的蛋白尿发生率(6.90% vs. 24.3%, p = 0.028)和非白蛋白蛋白尿发生率(6.67% vs. 22.9%, p = 0.031)显著降低。较高的基线βHB水平与蛋白尿风险降低相关(风险比0.313,95%可信区间0.110-0.891),经混杂因素调整。结论:在新诊断的2型糖尿病患者中,较高的基线空腹血清βHB水平与较低的蛋白尿风险相关,提示其可能是早期糖尿病肾病的保护性代谢标志物。
{"title":"Protective Role of Serum β-Hydroxybutyrate in Early Diabetic Kidney Disease: A Longitudinal Study.","authors":"So Ra Kim, Minyoung Lee, Yong-Ho Lee, Eun Seok Kang, Bong-Soo Cha, Byung-Wan Lee","doi":"10.1007/s13300-025-01819-3","DOIUrl":"10.1007/s13300-025-01819-3","url":null,"abstract":"<p><strong>Introduction: </strong>β-Hydroxybutyrate (βHB), the most stable form of ketone bodies, has exhibited protective effects in metabolic and chronic diseases. This study aimed to assess the association between fasting serum βHB levels, measured at baseline in drug-naïve state, and the risk of proteinuria in patients with newly diagnosed type 2 diabetes.</p><p><strong>Methods: </strong>In this longitudinal study involving 280 patients, baseline fasting serum βHB levels, urine protein parameters, and metabolic parameters were evaluated. To monitor the development of albuminuria (spot urine albumin-to-creatinine ratio ≥ 30.0 mg/gCr) or proteinuria (spot urine protein-to-creatinine ratio > 0.15 g/gCr), patients with normal baseline levels were followed for a mean of 2.40 ± 1.40 years.</p><p><strong>Results: </strong>Patients were classified into the highest tertile of baseline serum βHB level group and two other lower tertiles. The highest tertile group (median fasting serum βHB: 0.30 mmol/l) had a significantly lower incidence of proteinuria (6.90% vs. 24.3%, p = 0.028) and nonalbumin proteinuria (6.67% vs. 22.9%, p = 0.031) compared to the lower two tertiles. Higher baseline βHB levels were associated with a reduced risk of proteinuria (hazard ratio 0.313, 95% confidence interval 0.110-0.891), adjusted for confounders.</p><p><strong>Conclusion: </strong>Higher baseline fasting serum βHB levels are linked to a lower risk of proteinuria in newly diagnosed type 2 diabetes, suggesting its potential as a protective metabolic marker in early diabetic kidney disease.</p>","PeriodicalId":11192,"journal":{"name":"Diabetes Therapy","volume":" ","pages":"2333-2349"},"PeriodicalIF":2.6,"publicationDate":"2025-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12623558/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145426723","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"Letter to the Editor regarding \"Association Between Diabetes Management Behaviors and State-Level Social Vulnerability: A Cross-sectional Study\".","authors":"Schawanya Kaewpitoon Rattanapitoon, Natnapa Heebkaew Padchasuwan, Nav La, Nathkapach Kaewpitoon Rattanapitoon","doi":"10.1007/s13300-025-01806-8","DOIUrl":"10.1007/s13300-025-01806-8","url":null,"abstract":"","PeriodicalId":11192,"journal":{"name":"Diabetes Therapy","volume":" ","pages":"2365-2367"},"PeriodicalIF":2.6,"publicationDate":"2025-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12623533/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145312557","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2025-12-01Epub Date: 2025-11-01DOI: 10.1007/s13300-025-01814-8
Nathalie Jeandidier, Arthur Bagel, Alice Bonin, Gabriel Guigand, Bruno Guerci
Introduction: This study aimed to examine glucose metrics and insulin delivery patterns in children, adolescents, and adults with type 1 (T1D) or 2 (T2D) diabetes in France using the tubeless Omnipod DASH® pump with and a continuous glucose monitoring (CGM) sensor connected to myDiabby Healthcare® Data Management Platform (DMP).
Methods: Time-stamped CGM and insulin data were extracted from the DMP on December 6, 2023 for 17,344 users whose first data point from the tubeless pump occurred after January 1, 2020. The study population included users with sufficient pump and CGM data (≥ 90 days of use) and ≥ 15.5% of CGM use days reaching > 70% coverage. Analyses were performed by type of diabetes and age group.
Results: Among 14,757 users included in this analysis, most reported having T1D (93.7%), the median age was 33 years (Q1-Q3, 16-51), and the median duration of pump use was 545 days for people with T1D and 505 days for people with T2D (1.49 and 1.38 years, respectively). People with T1D spent a median of 52.5% (Q1-Q3, 43.4-62.5) of time in range (70-180 mg/dL, TIR) and a TIR ≥ 70% was attained by 12.6% of users. The median time below range (TBR, < 70 mg/dL) was 3.7% (Q1-Q3, 2.1-6.1). For users with T2D, median TIR was 66.9% (Q1-Q3, 54.0-77.8), with 42.8% of users achieving a TIR ≥ 70%. Over 90% of all users consumed less than 60 UI/day.
Conclusion: This robust and scalable analysis of a database of substantial quantity, density, and quality found that tubeless pump users achieved moderate glycemic outcomes overall with favorablesafety outcomes in particular, and used the pump consistently. Such databases could be useful for research and patient care, and further work will show how best to use them.
{"title":"Tubeless Insulin Pump Combined with a Cloud-Based Data Management Platform: Real-World Evidence from 14,765 French People with Diabetes.","authors":"Nathalie Jeandidier, Arthur Bagel, Alice Bonin, Gabriel Guigand, Bruno Guerci","doi":"10.1007/s13300-025-01814-8","DOIUrl":"10.1007/s13300-025-01814-8","url":null,"abstract":"<p><strong>Introduction: </strong>This study aimed to examine glucose metrics and insulin delivery patterns in children, adolescents, and adults with type 1 (T1D) or 2 (T2D) diabetes in France using the tubeless Omnipod DASH<sup>®</sup> pump with and a continuous glucose monitoring (CGM) sensor connected to myDiabby Healthcare<sup>®</sup> Data Management Platform (DMP).</p><p><strong>Methods: </strong>Time-stamped CGM and insulin data were extracted from the DMP on December 6, 2023 for 17,344 users whose first data point from the tubeless pump occurred after January 1, 2020. The study population included users with sufficient pump and CGM data (≥ 90 days of use) and ≥ 15.5% of CGM use days reaching > 70% coverage. Analyses were performed by type of diabetes and age group.</p><p><strong>Results: </strong>Among 14,757 users included in this analysis, most reported having T1D (93.7%), the median age was 33 years (Q1-Q3, 16-51), and the median duration of pump use was 545 days for people with T1D and 505 days for people with T2D (1.49 and 1.38 years, respectively). People with T1D spent a median of 52.5% (Q1-Q3, 43.4-62.5) of time in range (70-180 mg/dL, TIR) and a TIR ≥ 70% was attained by 12.6% of users. The median time below range (TBR, < 70 mg/dL) was 3.7% (Q1-Q3, 2.1-6.1). For users with T2D, median TIR was 66.9% (Q1-Q3, 54.0-77.8), with 42.8% of users achieving a TIR ≥ 70%. Over 90% of all users consumed less than 60 UI/day.</p><p><strong>Conclusion: </strong>This robust and scalable analysis of a database of substantial quantity, density, and quality found that tubeless pump users achieved moderate glycemic outcomes overall with favorablesafety outcomes in particular, and used the pump consistently. Such databases could be useful for research and patient care, and further work will show how best to use them.</p>","PeriodicalId":11192,"journal":{"name":"Diabetes Therapy","volume":" ","pages":"2293-2310"},"PeriodicalIF":2.6,"publicationDate":"2025-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12623546/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145426768","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2025-12-01Epub Date: 2025-10-18DOI: 10.1007/s13300-025-01807-7
Debra Winberg, Nicolas Marchi, Tiange Tang, Lizheng Shi
{"title":"A Response to: Letter to the Editor Regarding Association Between Diabetes Management Behaviors and State-Level Social Vulnerability: A Cross-Sectional Study.","authors":"Debra Winberg, Nicolas Marchi, Tiange Tang, Lizheng Shi","doi":"10.1007/s13300-025-01807-7","DOIUrl":"10.1007/s13300-025-01807-7","url":null,"abstract":"","PeriodicalId":11192,"journal":{"name":"Diabetes Therapy","volume":" ","pages":"2369-2371"},"PeriodicalIF":2.6,"publicationDate":"2025-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12623588/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145312526","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2025-12-01Epub Date: 2025-10-18DOI: 10.1007/s13300-025-01805-9
Keiko Arai, Tetsuo Nishikawa, Shohei Yuasa, Koichi Hirao, Hisao Mori
Introduction: In recent years, diabetes management by diabetes specialists has evolved owing to various factors such as the introduction of new glucose-lowering drugs. In Japan, many patients with diabetes mellitus are managed by general practitioners (GPs), with the quality of management provided by these GPs playing a crucial role in preventing diabetes-related complications. Despite this importance, trends in diabetes management by GPs remain unclear. This study aimed to assess changes in diabetes management by GPs, comparing data from two nationwide surveys conducted in 2006 and 2018.
Methods: We compared the characteristics and pharmacotherapy of patients with type 2 diabetes (T2DM) managed by GPs and diabetes specialists in 2006 (14,312 and 1038 patients, respectively) and 2018 (6525 and 1545, respectively). Data on age, sex, glycosylated hemoglobin (HbA1c), body mass index (BMI), treatment modalities, types and number of oral antidiabetic drugs (OADs), types of sulfonylureas (SUs), and dose of SUs were compared between the two surveys.
Results: In 2018, patients with T2DM managed by GPs were older and had higher BMI, while exhibiting improved HbA1c levels compared to those in 2006. Dipeptidyl peptidase 4 inhibitors and biguanides were the most and second most frequently prescribed OADs, respectively, with SUs being less prescribed at lower doses. Combination OAD therapy was also more prevalent in 2018 than in 2006.
Conclusion: The observed trends with GPs were consistent with those observed among diabetes specialists, suggesting that many Japanese GPs are adopting current treatments strategies and may be providing appropriate diabetes management.
{"title":"Trends in the Management of Patients with Type 2 Diabetes Mellitus by Japanese Practitioners.","authors":"Keiko Arai, Tetsuo Nishikawa, Shohei Yuasa, Koichi Hirao, Hisao Mori","doi":"10.1007/s13300-025-01805-9","DOIUrl":"10.1007/s13300-025-01805-9","url":null,"abstract":"<p><strong>Introduction: </strong>In recent years, diabetes management by diabetes specialists has evolved owing to various factors such as the introduction of new glucose-lowering drugs. In Japan, many patients with diabetes mellitus are managed by general practitioners (GPs), with the quality of management provided by these GPs playing a crucial role in preventing diabetes-related complications. Despite this importance, trends in diabetes management by GPs remain unclear. This study aimed to assess changes in diabetes management by GPs, comparing data from two nationwide surveys conducted in 2006 and 2018.</p><p><strong>Methods: </strong>We compared the characteristics and pharmacotherapy of patients with type 2 diabetes (T2DM) managed by GPs and diabetes specialists in 2006 (14,312 and 1038 patients, respectively) and 2018 (6525 and 1545, respectively). Data on age, sex, glycosylated hemoglobin (HbA1c), body mass index (BMI), treatment modalities, types and number of oral antidiabetic drugs (OADs), types of sulfonylureas (SUs), and dose of SUs were compared between the two surveys.</p><p><strong>Results: </strong>In 2018, patients with T2DM managed by GPs were older and had higher BMI, while exhibiting improved HbA1c levels compared to those in 2006. Dipeptidyl peptidase 4 inhibitors and biguanides were the most and second most frequently prescribed OADs, respectively, with SUs being less prescribed at lower doses. Combination OAD therapy was also more prevalent in 2018 than in 2006.</p><p><strong>Conclusion: </strong>The observed trends with GPs were consistent with those observed among diabetes specialists, suggesting that many Japanese GPs are adopting current treatments strategies and may be providing appropriate diabetes management.</p>","PeriodicalId":11192,"journal":{"name":"Diabetes Therapy","volume":" ","pages":"2265-2274"},"PeriodicalIF":2.6,"publicationDate":"2025-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12623517/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145312523","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2025-12-01Epub Date: 2025-11-01DOI: 10.1007/s13300-025-01811-x
Johan Jendle, Sabrina Ilham, Hamza Alshannaq, Jessica Y Matuoka, Richard F Pollock, Waqas Ahmed, Gregory J Norman
Introduction: The aim of this study was to investigate the cost-utility of real-time continuous glucose monitoring (rt-CGM) versus self-monitoring of blood glucose (SMBG) in people with insulin-treated type 2 diabetes (T2D) in Sweden.
Methods: The CORE Diabetes Model (CDM v10) was used for the analysis. Clinical effectiveness data were obtained from the Steno2Tech trial, an investigator-initiated, 12-month, single center randomized controlled trial based in Denmark. Adverse event rates were sourced from a large-scale observational study based in the USA. Costs were obtained from Swedish and European studies and inflated to 2023 Swedish Krona (SEK). The analysis adopted the perspective of the Swedish payer, and a remaining lifetime horizon was used in the base case. A discount rate of 3% was applied to future costs and outcomes on an annual basis. A commonly cited willingness-to-pay (WTP) threshold of SEK 500,000 was used.
Results: rt-CGM led to a gain in mean incremental survival by 0.082 years (11.529 life years for rt-CGM versus 11.447 life years for SMBG). Total mean incremental costs were SEK 138,448 higher with rt-CGM compared with SMBG (SEK 1,151,049 for rt-CGM versus SEK 1,012,601 for SMBG). However, rt-CGM incurred fewer overall diabetes-related complication costs than SMBG over the remaining lifetime horizon. Rt-CGM also yielded a gain in mean incremental quality-adjusted life years (QALYs) of 0.632 (8.608 QALYs for rt-CGM versus 7.976 QALYs for SMBG). The mean incremental cost-utility ratio (ICUR) for rt-CGM was SEK 219,063 per QALY gained, which showed rt-CGM to be cost-effective when compared with the WTP threshold of SEK 500,000. When various indirect cost estimates were incorporated, rt-CGM was consistently more cost-effective than in the base case analysis.
Conclusions: For individuals living in Sweden with T2D requiring insulin treatment, rt-CGM is a cost-effective management option relative to SMBG.
{"title":"Cost-Utility of Real-Time Continuous Glucose Monitoring Versus Self-monitoring of Blood Glucose in People with Insulin-Treated Type 2 Diabetes in Sweden.","authors":"Johan Jendle, Sabrina Ilham, Hamza Alshannaq, Jessica Y Matuoka, Richard F Pollock, Waqas Ahmed, Gregory J Norman","doi":"10.1007/s13300-025-01811-x","DOIUrl":"10.1007/s13300-025-01811-x","url":null,"abstract":"<p><strong>Introduction: </strong>The aim of this study was to investigate the cost-utility of real-time continuous glucose monitoring (rt-CGM) versus self-monitoring of blood glucose (SMBG) in people with insulin-treated type 2 diabetes (T2D) in Sweden.</p><p><strong>Methods: </strong>The CORE Diabetes Model (CDM v10) was used for the analysis. Clinical effectiveness data were obtained from the Steno2Tech trial, an investigator-initiated, 12-month, single center randomized controlled trial based in Denmark. Adverse event rates were sourced from a large-scale observational study based in the USA. Costs were obtained from Swedish and European studies and inflated to 2023 Swedish Krona (SEK). The analysis adopted the perspective of the Swedish payer, and a remaining lifetime horizon was used in the base case. A discount rate of 3% was applied to future costs and outcomes on an annual basis. A commonly cited willingness-to-pay (WTP) threshold of SEK 500,000 was used.</p><p><strong>Results: </strong>rt-CGM led to a gain in mean incremental survival by 0.082 years (11.529 life years for rt-CGM versus 11.447 life years for SMBG). Total mean incremental costs were SEK 138,448 higher with rt-CGM compared with SMBG (SEK 1,151,049 for rt-CGM versus SEK 1,012,601 for SMBG). However, rt-CGM incurred fewer overall diabetes-related complication costs than SMBG over the remaining lifetime horizon. Rt-CGM also yielded a gain in mean incremental quality-adjusted life years (QALYs) of 0.632 (8.608 QALYs for rt-CGM versus 7.976 QALYs for SMBG). The mean incremental cost-utility ratio (ICUR) for rt-CGM was SEK 219,063 per QALY gained, which showed rt-CGM to be cost-effective when compared with the WTP threshold of SEK 500,000. When various indirect cost estimates were incorporated, rt-CGM was consistently more cost-effective than in the base case analysis.</p><p><strong>Conclusions: </strong>For individuals living in Sweden with T2D requiring insulin treatment, rt-CGM is a cost-effective management option relative to SMBG.</p>","PeriodicalId":11192,"journal":{"name":"Diabetes Therapy","volume":" ","pages":"2311-2331"},"PeriodicalIF":2.6,"publicationDate":"2025-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12623549/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145426743","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}