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1956-LB: Artificial Intelligence vs. Human Coaching for Diabetes Prevention—Results from a 12-Month, Multicenter, Pragmatic Randomized Controlled Trial 1956-LB:人工智能与人类指导预防糖尿病——来自12个月、多中心、实用的随机对照试验的结果
IF 7.7 1区 医学
Diabetes Pub Date : 2025-06-20 DOI: 10.2337/db25-1956-lb
NESTORAS N. MATHIOUDAKIS, MOHAMMED S. ABUSAMAAN, MARY E. ALDERFER, DEFNE ALVER, ADRIAN S. DOBS, BRIAN KANE, BENJAMIN LALANI, JOHN MCGREADY, KRISTIN RIEKERT, BENJAMIN RINGHAM, FATMATA VANDI, AMAL A. WANIGATUNGA, DANIEL ZADE, NISA M. MARUTHUR
{"title":"1956-LB: Artificial Intelligence vs. Human Coaching for Diabetes Prevention—Results from a 12-Month, Multicenter, Pragmatic Randomized Controlled Trial","authors":"NESTORAS N. MATHIOUDAKIS, MOHAMMED S. ABUSAMAAN, MARY E. ALDERFER, DEFNE ALVER, ADRIAN S. DOBS, BRIAN KANE, BENJAMIN LALANI, JOHN MCGREADY, KRISTIN RIEKERT, BENJAMIN RINGHAM, FATMATA VANDI, AMAL A. WANIGATUNGA, DANIEL ZADE, NISA M. MARUTHUR","doi":"10.2337/db25-1956-lb","DOIUrl":"https://doi.org/10.2337/db25-1956-lb","url":null,"abstract":"Introduction and Objective: Prediabetes is highly prevalent, yet few patients receive evidence-based behavioral lifestyle support. Artificial intelligence (AI) may offer a scalable approach to diabetes prevention. This study evaluated whether a fully automated AI-based diabetes prevention program (ai-DPP), consisting of a mobile app and digital body weight scale, is non-inferior to a traditional human coach-based DPP (h-DPP) in adults with prediabetes and overweight or obesity. Methods: We conducted a two-site, pragmatic, RCT involving adults with prediabetes and overweight or obesity (NCT05056376). Participants were randomly assigned (1:1) to either an ai-DPP (Sweetch Health, Ltd) or a CDC-recognized h-DPP for a 12-month intervention. Physical activity was objectively measured using actigraphy. The primary endpoint, assessed at 12 months, was the CDC-defined composite diabetes risk reduction outcome, including achieving 5% weight loss, 4% weight loss plus 150 minutes of weekly physical activity, or a 0.2 reduction in A1C. The pre-specified non-inferiority margin was 15 percentage points. The primary outcome was analyzed using a modified intention-to-treat (mITT) approach, including participants with available 12-month data who did not use prohibited medications. Results: Of 427 screened, 368 were enrolled (183 ai-DPP, 185 h-DPP). Trial completion (85.1%) and prohibited medication use (3.5%) were similar between arms, leaving 300 (151 ai-DPP, 149 h-DPP) in the mITT analysis. Achievement of the primary outcome was similar between groups (ai-DPP: 35.8%, h-DPP: 35.6%; p = 0.97). The age - and sex-adjusted risk difference was -2.6% (lower 95% CI: -11.6%), demonstrating non-inferiority. Individual endpoints in the composite outcome also showed non-inferiority. Conclusion: A fully autonomous AI-based DPP requiring no human coaching is non-inferior to the traditional human-coach based DPP, presenting a promising, scalable alternative for adults with prediabetes. Disclosure N.N. Mathioudakis: None. M.S. Abusamaan: None. M.E. Alderfer: None. D. Alver: None. A.S. Dobs: None. B. Kane: None. B. Lalani: None. J. McGready: None. K. Riekert: None. B. Ringham: None. F. Vandi: None. A.A. Wanigatunga: None. D. Zade: None. N.M. Maruthur: None. Funding The National Institute of Diabetes and Digestive and Kidney Diseases (R01DK125780).","PeriodicalId":11376,"journal":{"name":"Diabetes","volume":"45 1","pages":""},"PeriodicalIF":7.7,"publicationDate":"2025-06-20","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144335119","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
1373-P: Comparison of Characteristics among Individuals with Established vs. Newly Diagnosed Type 2 Diabetes during Ischemic Stroke Hospitalization—A Retrospective Cohort Study 1373-P:缺血性卒中住院期间确诊与新诊断2型糖尿病患者特征的比较——一项回顾性队列研究
IF 7.7 1区 医学
Diabetes Pub Date : 2025-06-20 DOI: 10.2337/db25-1373-p
CAICHEN ZHONG, SETH EMONT, LIN XIE, SUNDAY IKPE, ZHUN CAO, CRAIG B. LIPKIN, JOSHUA NOONE, EMILY ZACHERLE, CHALAK MUHAMMAD, ADAM DE HAVENON
{"title":"1373-P: Comparison of Characteristics among Individuals with Established vs. Newly Diagnosed Type 2 Diabetes during Ischemic Stroke Hospitalization—A Retrospective Cohort Study","authors":"CAICHEN ZHONG, SETH EMONT, LIN XIE, SUNDAY IKPE, ZHUN CAO, CRAIG B. LIPKIN, JOSHUA NOONE, EMILY ZACHERLE, CHALAK MUHAMMAD, ADAM DE HAVENON","doi":"10.2337/db25-1373-p","DOIUrl":"https://doi.org/10.2337/db25-1373-p","url":null,"abstract":"Introduction and Objective: While newly diagnosed type 2 diabetes (T2D) at the time of a stroke is associated with poorer outcomes, characteristics comparing individuals diagnosed with T2D during stroke hospitalization and those with previously established T2D are not very well documented. This study aimed to examine the differences between the two groups. Methods: This retrospective, observational cohort study included adults hospitalized with an ischemic stroke from 07/01/2017 to 03/31/2023 utilizing the PINC AI™ Healthcare Database. Descriptive statistics were used to compare sociodemographic and clinical characteristics during and after hospitalization among individuals with a T2D diagnosis or anti-diabetic medication use before hospitalization (estT2D) and those with a discharge T2D diagnosis or laboratory values indicating T2D during hospitalization without prior evidence of T2D diagnosis (newT2D). Results: Compared to those with estT2D (N=103,060), individuals with newT2D (N=127,286) were younger (mean±SD: 68.6±12.5 vs 71.0±12.5 years), more likely to be male (55.4% vs 49.3%) and less likely to be enrolled in Medicare (61.8% vs 74.8%). Individuals with newT2D had a lower Charlson comorbidity index (CCI) score (mean±SD: 4.7±2.1 vs 5.5±2.4) and were more likely to be in the highest quintile of social vulnerability index (23.5% vs 21.3%). Individuals with newT2D also had longer lengths of stay (mean±SD: 5.6±5.7 vs 5.2±5.0 days), higher all-cause mortality during hospitalization (4.4% vs 3.6%) and lower all-cause 30-day readmission post discharge (11.8% vs 16.6%), compared to those with estT2D. Conclusion: Individuals hospitalized with stroke and newT2D had lower CCI scores and 30-day readmission rates compared to those with estT2D. They also experienced longer hospital stays and higher inpatient mortality. Our results highlight the need for early diagnosis and management of T2D. Disclosure C. Zhong: None. S. Emont: Other Relationship; Novo Nordisk. Employee; Premier, Inc. L. Xie: None. S. Ikpe: None. Z. Cao: Other Relationship; Novo Nordisk. Employee; Premier Inc. C.B. Lipkin: Employee; Premier Inc. J. Noone: Employee; Novo Nordisk. E. Zacherle: Employee; Novo Nordisk. C. Muhammad: Employee; Novo Nordisk. A. de Havenon: Consultant; Novo Nordisk.","PeriodicalId":11376,"journal":{"name":"Diabetes","volume":"12 1","pages":""},"PeriodicalIF":7.7,"publicationDate":"2025-06-20","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144335124","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
798-P: Semaglutide Effect during Mixed-Meal Tolerance Test (MMTT) with Fully Closed-Loop Therapy in Type 1 Diabetes (T1D) 798-P:在1型糖尿病(T1D)全闭环治疗的混合膳食耐量试验(MMTT)中,西马鲁肽的作用
IF 7.7 1区 医学
Diabetes Pub Date : 2025-06-20 DOI: 10.2337/db25-798-p
MELISSA-ROSINA PASQUA, JOELLE DOUMAT, ADNAN JAFAR, MICHAEL TSOUKAS, AHMAD HAIDAR
{"title":"798-P: Semaglutide Effect during Mixed-Meal Tolerance Test (MMTT) with Fully Closed-Loop Therapy in Type 1 Diabetes (T1D)","authors":"MELISSA-ROSINA PASQUA, JOELLE DOUMAT, ADNAN JAFAR, MICHAEL TSOUKAS, AHMAD HAIDAR","doi":"10.2337/db25-798-p","DOIUrl":"https://doi.org/10.2337/db25-798-p","url":null,"abstract":"Introduction and Objective: We assessed glycemia, insulin needs, and C-peptide levels with semaglutide after MMTT in type 1 diabetes. Methods: This is a sub-analysis of a randomized crossover trial assessing semaglutide vs. placebo with automated insulin delivery (AID) in adults with T1D (NCT05205928). Participants performed a MMTT with 6 mL/kg of Boost, while using fully-closed-loop AID, after 12 weeks of semaglutide and placebo, in random order. Plasma glucose and C-peptide levels were measured over 120 minutes. C-peptide levels <0.003 nmol/L assumed to be 0 nmol/L. Paired t-test was performed for parametric comparisons, with Wilcoxin signed-rank test for non-parametric comparisons. Results: Ten participants completed the MMTT, with 8 having C-peptide levels and 7 having pump data; 40% were female, with age 47 (SD 14) years and T1D duration 29 (11) years. All but one had baseline C-peptide of < 0.003 pmol/L. Semaglutide reduced glucose AUC compared to placebo (p=0.006), but C-peptide AUC was not different between arms (p=0.35). Despite having lower glucose AUC, the insulin delivery by the AID was lower for semaglutide than placebo (p = 0.024). Conclusion: Semaglutide reduced glucose AUC during fully closed-loop therapy after weight-adjusted meal replacement, with less insulin output required from the AID. Further studies are needed to understand mechanistic of effects. Disclosure M. Pasqua: Speaker's Bureau; Abbott, Sanofi, Medtronic. J. Doumat: None. A. Jafar: None. M. Tsoukas: Speaker's Bureau; Novo Nordisk, Eli Lilly and Company, Boehringer-Ingelheim, Janssen Pharmaceuticals, Inc, Sanofi. A. Haidar: Research Support; Tandem Diabetes Care, Inc. Consultant; Eli Lilly and Company, Abbott. Research Support; ADOCIA, Dexcom, Inc., Ypsomed AG, Bigfoot Biomedical, Inc. Funding Canada Research Chair in Artificial Pancreas Systems.","PeriodicalId":11376,"journal":{"name":"Diabetes","volume":"25 1","pages":""},"PeriodicalIF":7.7,"publicationDate":"2025-06-20","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144335126","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
1660-P: Examining the Effects of Menstruation on Diabetes Management among People with Diabetes in the U.S. and EU 1660-P:在美国和欧盟糖尿病患者中检查月经对糖尿病管理的影响
IF 7.7 1区 医学
Diabetes Pub Date : 2025-06-20 DOI: 10.2337/db25-1660-p
ANURADHA KRISHNAN, SYDNEY CHANEN, TREVOR BELL, TRACY L. BRISTOW, RICHARD WOOD
{"title":"1660-P: Examining the Effects of Menstruation on Diabetes Management among People with Diabetes in the U.S. and EU","authors":"ANURADHA KRISHNAN, SYDNEY CHANEN, TREVOR BELL, TRACY L. BRISTOW, RICHARD WOOD","doi":"10.2337/db25-1660-p","DOIUrl":"https://doi.org/10.2337/db25-1660-p","url":null,"abstract":"Introduction and Objective: Hormonal fluctuations associated with menstruation can significantly affect women’s insulin sensitivity and blood glucose levels, posing challenges for diabetes management. Despite affecting half of the population, the intersection of menstruation and diabetes is largely understudied. This study aimed to examine the perceived effects of menstruation on diabetes management and identify critical knowledge and care gaps among people with diabetes (PWD) in the United States (US) and Europe (EU). Methods: From Oct.-Nov. 2024, menstruating PWD in the US (n=686) and EU (n=899) completed an online survey in which they reported overall satisfaction with their glycemic control, the impact of menstruation on their diabetes management, and whether they have discussed these issues with a healthcare provider (HCP). They also provided open-ended feedback on desired changes in diabetes care. Results: Few women report high satisfaction with their overall glycemic control, especially in the EU (19% US vs 14% EU, p<0.05). In both regions, over half of respondents report worsened control during menstruation (56% US, 55% EU), driven by women with Type 1 diabetes (T1) (60% T1 vs 23% T2, p<0.05). Only 36% of women have discussed menstruation’s impact with their HCP, less so among T2 women—particularly non-insulin users (39% T1, 32% T2 on insulin, 17% T2 non-insulin; p<0.05). Qualitatively, many women with diabetes report a lack of information on how hormonal changes affect glycemic control and pump users also express a need for personalized technology that caters to both diabetes and menstruation. Conclusion: These findings highlight unmet needs in gender-based diabetes care. The hormonal changes associated with menstruation must be addressed as key factors in diabetes management and incorporated into clinical discussions, care strategies, and diabetes technologies. Future research should explore the hormonal mechanisms influencing blood glucose and the impact of different menstrual cycle stages on glycemic control. Disclosure A. Krishnan: Research Support; Abbott, Dexcom, Inc., Eli Lilly and Company, diaTribe, Insulet Corporation, Medtronic, Roche Diabetes Care, Tandem Diabetes Care, Inc, Ypsomed AG, LifeScan Diabetes Institute. S. Chanen: Research Support; Abbott, Dexcom, Inc., Eli Lilly and Company, diaTribe, Insulet Corporation, Medtronic, Roche Diabetes Care, Ypsomed AG, Tandem Diabetes Care, Inc, LifeScan Diabetes Institute. T. Bell: Research Support; Abbott, Dexcom, Inc., Tandem Diabetes Care, Inc, Medtronic, MannKind Corporation, Insulet Corporation, CeQur, Beta Bionics, Inc, Eli Lilly and Company, Ypsomed AG. T.L. Bristow: None. R. Wood: Other Relationship; Abbott, diaTribe, Glooko, Inc, Dexcom, Inc., Medtronic, Lilly Diabetes, Insulet Corporation, Sanofi-Aventis U.S., Tandem Diabetes Care, Inc, Zucara Therapeutics.","PeriodicalId":11376,"journal":{"name":"Diabetes","volume":"51 1","pages":""},"PeriodicalIF":7.7,"publicationDate":"2025-06-20","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144335006","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
140-OR: Durable Glycemic Control and Elimination of Exogenous Insulin Use with VX-880 in Patients with Type 1 Diabetes (T1D)—VX-880-101 (FORWARD) 140-OR: VX-880在1型糖尿病(T1D)患者中持久的血糖控制和消除外源性胰岛素使用
IF 7.7 1区 医学
Diabetes Pub Date : 2025-06-20 DOI: 10.2337/db25-140-or
MICHAEL R. RICKELS, PIOTR WITKOWSKI, TREVOR W. REICHMAN, EELCO J. DE KONING, JAMES F. MARKMANN, JON S. ODORICO, MARTIN WIJKSTROM, LESLIE S. KEAN, CHANTAL MATHIEU, ANNE L. PETERS, YAOYUAN VINCENT TAN, KRISTINE VANIJCHAROENKARN, DOUGLAS MELTON, FELICIA PAGLIUCA, BOTE BRUINSMA, GAUTHAM MARIGOWDA, CAMILLO RICORDI
{"title":"140-OR: Durable Glycemic Control and Elimination of Exogenous Insulin Use with VX-880 in Patients with Type 1 Diabetes (T1D)—VX-880-101 (FORWARD)","authors":"MICHAEL R. RICKELS, PIOTR WITKOWSKI, TREVOR W. REICHMAN, EELCO J. DE KONING, JAMES F. MARKMANN, JON S. ODORICO, MARTIN WIJKSTROM, LESLIE S. KEAN, CHANTAL MATHIEU, ANNE L. PETERS, YAOYUAN VINCENT TAN, KRISTINE VANIJCHAROENKARN, DOUGLAS MELTON, FELICIA PAGLIUCA, BOTE BRUINSMA, GAUTHAM MARIGOWDA, CAMILLO RICORDI","doi":"10.2337/db25-140-or","DOIUrl":"https://doi.org/10.2337/db25-140-or","url":null,"abstract":"Introduction and Objective: VX-880 is an allogeneic stem cell-derived, fully differentiated islet cell therapy in clinical development for T1D. Methods: This single-arm, open-label, phase 1/2/3 trial is evaluating VX-880 in T1D adults with impaired hypoglycemia awareness and ≥2 severe hypoglycemic episodes (SHEs) the year before enrollment. Participants receive a standard immunosuppression regimen. Enrollment and dosing in the phase 1/2 portion has completed and phase 3 is ongoing. Results: These results reflect 12 participants who received a full VX-880 dose as a single infusion and were followed for at least one year, as of October 2024. At baseline, all participants had multiple SHEs and undetectable fasting C-peptide. All 12 participants demonstrated engraftment with glucose responsive C-peptide production at Day (D)90 MMTT which was durable through Month (M)12. All 12 participants achieved ADA HbA1c target of <7% (mean: baseline=7.8%; M12=6.0%) and time in range target of >70% (mean: baseline=49.5%; M12=93%); and all were free of SHEs from D90 onwards. All 12 participants had reduction in exogenous insulin use (mean reduction: 92%) and 10/12 (83%) no longer required exogenous insulin at M12. Median duration free of exogenous insulin was 232 (69 to 441) days. All 12 participants were evaluable for and achieved the phase 1/2 primary endpoint of elimination of SHEs and HbA1c <7%. Most adverse events (AEs) were mild or moderate in severity. There were no VX-880-related serious AEs. Two deaths occurred; both were reported previously and unrelated to VX-880. Overall, the safety profile was consistent with the immunosuppressive regimen and islet infusion procedure. Conclusion: These durable clinical benefits of VX-880 with elimination of SHEs, improved glycemic control, and freedom from exogenous insulin support the curative potential of VX-880, the first and only allogeneic, stem-cell derived, islet cell therapy in pivotal development. Disclosure M.R. Rickels: Consultant; Vertex Pharmaceuticals Incorporated, Sernova, Corp. Research Support; Dompé, Tandem Diabetes Care, Inc. Consultant; Novo Nordisk. P. Witkowski: Advisory Panel; Vertex Pharmaceuticals Incorporated. Research Support; Sernova, Corp. Stock/Shareholder; Eledon. T.W. Reichman: Research Support; Vertex Pharmaceuticals Incorporated. Advisory Panel; Novo Nordisk. E.J. de Koning: None. J.F. Markmann: Consultant; iTolerance, Inc, Vertex Pharmaceuticals Incorporated. J.S. Odorico: Other Relationship; Regenerative Medical Solutions, Inc. Research Support; Juvenile Diabetes Research Foundation (JDRF). Other Relationship; Vertex Pharmaceuticals Incorporated, Veloxis. Research Support; National Institute of Diabetes and Digestive and Kidney Diseases. Consultant; UpToDate, Sernova, Corp. M. Wijkstrom: Consultant; Vertex Pharmaceuticals Incorporated. L.S. Kean: Consultant; Vertex Pharmaceuticals Incorporated. Research Support; Bristol-Myers Squibb Company, Tessera, Gilead Scie","PeriodicalId":11376,"journal":{"name":"Diabetes","volume":"8 1","pages":""},"PeriodicalIF":7.7,"publicationDate":"2025-06-20","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144334854","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
1910-LB: Effects of a 6-Month Lifestyle Intervention for Type 2 Diabetes Featuring Intermittent Energy Restriction or Time-Restricted Eating on Glucose Tolerance and Body Weight 1910-LB: 6个月生活方式干预2型糖尿病间歇性能量限制或限时饮食对葡萄糖耐量和体重的影响
IF 7.7 1区 医学
Diabetes Pub Date : 2025-06-20 DOI: 10.2337/db25-1910-lb
FELICIA STEGER, KRISTINE GRDINOVAC, JOSEPH DONNELLY, CORBY K. MARTIN, JOHN MILES, ROBERT MONTGOMERY, LAUREN CLARK, JOHN P. THYFAULT
{"title":"1910-LB: Effects of a 6-Month Lifestyle Intervention for Type 2 Diabetes Featuring Intermittent Energy Restriction or Time-Restricted Eating on Glucose Tolerance and Body Weight","authors":"FELICIA STEGER, KRISTINE GRDINOVAC, JOSEPH DONNELLY, CORBY K. MARTIN, JOHN MILES, ROBERT MONTGOMERY, LAUREN CLARK, JOHN P. THYFAULT","doi":"10.2337/db25-1910-lb","DOIUrl":"https://doi.org/10.2337/db25-1910-lb","url":null,"abstract":"Introduction and Objective: Intermittent energy restriction (IER) and time-restricted eating (TRE) are forms of intermittent fasting which produce clinically relevant weight loss and improve metabolic health. However, the two approaches have not been tested in parallel and few trials have tested these interventions in patients with type 2 diabetes (T2D). We hypothesized that both interventions would be feasible, significantly improve glycemia, and reduce body weight. Methods: This RCT enrolled 57 adults (21-65 years) with type 2 diabetes (HbA1c 6.7-9.5%) and overweight/obesity (BMI 25-45 kg/m²) to participate in a 6-month, comprehensive diabetes education intervention featuring IER or TRE with energy restriction (TRE+ER). TRE+ER adhered to a ≤8-hour eating window as often as possible or ≥5 days/week and also reduced energy intake during months 0 - 3. IER utilized 2-3 very low-calorie diet (VLCD) days/week during the weight loss phase (0 - 3 months) and as often as needed to maintain weight during the weight maintenance phase (3 - 6 months). The intervention included regular group meetings to facilitate behavior change, and individual medical monitoring visits. Assessments were conducted at baseline, 3, and 6 months, including anthropometric measures, HbA1c, and glucose area under the curve (AUC) in a mixed meal tolerance test. Results: Retention was 87% in IER and 93% in TRE+ER at 6 months, indicating feasibility. After 6 months, TRE+ER reduced HbA1c by -0.5% (-0.8, -0.1), glucose AUC by 61 mg*h/dL (-108, -13), and body weight by 8.1 kg (-10.8, -5.5). Similarly, IER reduced HbA1c by 0.6% (-0.9, -0.3), glucose AUC by 65 mg*h/dL (-100, -31), and reduced body weight by 6.9 kg (-9.6, -4.2). There were no differences between groups. Conclusion: TRE+ER and IER both led to statistically significant and clinically relevant improvements in HbA1c, glucose AUC, and body weight. Future studies should compare these strategies to standard-of-care diabetes education and treatment. Disclosure F. Steger: None. K. Grdinovac: Consultant; AmalgamRx. J. Donnelly: None. C.K. Martin: Advisory Panel; EHE Health, Wondr Health. Other Relationship; Academy of Nutrition and Dietetics, ABGIL. Research Support; Foundation for Food and Agriculture Research; Kroger Co. Zero Hunger / Zero Waste Foundation, Weight Watchers International, Eli Lilly and Company. Other Relationship; The Bray Course Planning Committee, Spoonified. J. Miles: None. R. Montgomery: None. L. Clark: None. J.P. Thyfault: None. Funding American Diabetes Association (7-22-JDFN-13); National Institutes of Health (5P20GM144269)","PeriodicalId":11376,"journal":{"name":"Diabetes","volume":"15 1","pages":""},"PeriodicalIF":7.7,"publicationDate":"2025-06-20","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144334848","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
2051-LB: Predictive Modeling for Presymptomatic Type 1 Diabetes Detection Using Open Claims Data 2051-LB:使用公开索赔数据进行症状前1型糖尿病检测的预测建模
IF 7.7 1区 医学
Diabetes Pub Date : 2025-06-20 DOI: 10.2337/db25-2051-lb
DANIEL EINOR, OLEKSANDR BUIKO, KENI C.S. LEE, LUKAS ADAMEK, BRANDON RUFINO, INNA YAROVA, JARED JOSLEYN
{"title":"2051-LB: Predictive Modeling for Presymptomatic Type 1 Diabetes Detection Using Open Claims Data","authors":"DANIEL EINOR, OLEKSANDR BUIKO, KENI C.S. LEE, LUKAS ADAMEK, BRANDON RUFINO, INNA YAROVA, JARED JOSLEYN","doi":"10.2337/db25-2051-lb","DOIUrl":"https://doi.org/10.2337/db25-2051-lb","url":null,"abstract":"Introduction and Objective: Type 1 Diabetes mellitus (T1D) progresses through distinct stages before clinical diagnosis, with early stages being asymptomatic. Integrating pre-symptomatic T1D detection can enable the proactive identification of patients at higher risk and facilitate earlier interventions. This study employed machine learning approaches on a U.S. open claims dataset to identify people at risk of presymptomatic T1D. Methods: A retrospective cohort analysis was conducted on 89,453 patients selected based on the modified Klompas algorithm with initial T1D diagnosis or insulin prescription between Jan 2016 and Dec 2023. The study utilized tree-based (XGBoost) and transformer-based (BERT) models. The performance was evaluated using Precision, Recall, Bayes factor, and Number Needed to Test (NNT). Feature importance was assessed using Shapley values. Results: BERT was found to have better performance than tree-based models featuring Precision of 0.09 vs 0.05; Recall of 0.8 vs 0.72; Bayes factor of 19.92 vs 10.75; NNT values of 11.6 vs 22.7, respectfully. In both models, elevated risk of T1D was most associated with lower age and male gender. Tree-based model showed that elevated occurrence of diagnoses related to digestive system and thyroid tests were also associated with presymptomatic T1D. Conclusion: Our findings suggest the potential for using claims records to identify presymptomatic T1D individuals. The models improved the detection rate from the standard prevalence of 1:200 to less than 1:23, significantly enhancing early detection efforts. Existing demographic, frequent digestive system diagnoses and routine endocrine tests could signal T1D risk. Utilizing the recency and frequency of medical events may enhance the predictability of early T1D onset. Such models could enable more targeted screening and access to timely interventions for improved clinical outcomes. Disclosure D. Einor: None. O. Buiko: None. K.C.S. Lee: Employee; Sanofi. L. Adamek: Employee; Sanofi. B. Rufino: Employee; Sanofi. I. Yarova: None. J. Josleyn: Employee; Sanofi.","PeriodicalId":11376,"journal":{"name":"Diabetes","volume":"7 1","pages":""},"PeriodicalIF":7.7,"publicationDate":"2025-06-20","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144334853","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
586-P: Effects of Replacing Diet Beverages with Water on Sustained Weight Loss and Type 2 Diabetes Remission—An 18-Month Randomized Clinical Trial 586-P:用水替代无糖饮料对持续减肥和2型糖尿病缓解的影响——一项为期18个月的随机临床试验
IF 7.7 1区 医学
Diabetes Pub Date : 2025-06-20 DOI: 10.2337/db25-586-p
MOHAMMAD MEHDI FARSHCHI NASR, AMENEH MADJD, HAMID R. FARSHCHI
{"title":"586-P: Effects of Replacing Diet Beverages with Water on Sustained Weight Loss and Type 2 Diabetes Remission—An 18-Month Randomized Clinical Trial","authors":"MOHAMMAD MEHDI FARSHCHI NASR, AMENEH MADJD, HAMID R. FARSHCHI","doi":"10.2337/db25-586-p","DOIUrl":"https://doi.org/10.2337/db25-586-p","url":null,"abstract":"Introduction and Objective: To evaluate the effects of replacing diet beverages (DBs) with water on the durability of weight loss and Type 2 Diabetes (T2D) remission over an 18-month weight management follow-up, which included a 6-month weight loss intervention and a subsequent 12-month weight maintenance program. Methods: 81 adult women with obesity or overweight and T2D, who usually consumed DBs in their diet, were randomly assigned to either substitute with water or continue drinking DBs 5 times/week after their lunch for the 18-month follow-up. Results: The participants who were randomly assigned were included in the study by using an intention-to-treat analysis. After the 18-month follow-up period, significant weight change (mean ± SD) in the water group was observed compared with the DBs group (-6.82 ± 2.73 kg vs. -4.85 ± 2.07kg) (P<0.001). Diabetes remission was achieved in 37/41 (90%) participants of the water group vs. 18/40 (45%) in the DBs group (P<0·0001). There were also significant changes in BMI, fasting plasma glucose, insulin levels, the homeostasis model assessment of insulin resistance, 2h postprandial glucose and serum triglyceride in the water group compared with DBs over the 18 months. Conclusion: Sustained replacement of DBs with water after the main meals in women with T2D may promote further weight reduction during an 18-month weight management program. It may also offer benefits in glycemic control and diabetes remission during the long-term diet plan. Disclosure M. Farshchi Nasr: None. A. Madjd: None. H.R. Farshchi: None.","PeriodicalId":11376,"journal":{"name":"Diabetes","volume":"26 1","pages":""},"PeriodicalIF":7.7,"publicationDate":"2025-06-20","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144335125","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
The Cardiac and Hemodynamic Effects of Ketone Bodies Are Abnormal in Patients With Type 1 Diabetes: A Randomized Controlled Trial 酮体对1型糖尿病患者心脏和血流动力学的影响异常:一项随机对照试验
IF 7.7 1区 医学
Diabetes Pub Date : 2025-06-17 DOI: 10.2337/db25-0243
Kristoffer Berg-Hansen, Maj Bangshaab, Nigopan Gopalasingam, Roni Nielsen, Mads Svart, Nikolaj Rittig, Niels Møller, Henrik Wiggers
{"title":"The Cardiac and Hemodynamic Effects of Ketone Bodies Are Abnormal in Patients With Type 1 Diabetes: A Randomized Controlled Trial","authors":"Kristoffer Berg-Hansen, Maj Bangshaab, Nigopan Gopalasingam, Roni Nielsen, Mads Svart, Nikolaj Rittig, Niels Møller, Henrik Wiggers","doi":"10.2337/db25-0243","DOIUrl":"https://doi.org/10.2337/db25-0243","url":null,"abstract":"Impaired cardiac ketone oxidative capacity is a possible disease mechanism in the development of diabetic cardiomyopathy. We examined whether the cardiovascular effects of ketone bodies are different in patients with type 1 diabetes (T1D) compared with healthy control individuals. In a single-blind study with a crossover design, nine patients with T1D and eight age-matched, healthy control study participants were randomized to receive a 3-h infusion of 3-hydroxybutyrate (3-OHB) or tonicity-matched saline in random order, separated by a 1-h washout period. Assessor-blinded echocardiographic evaluation of cardiovascular function was performed at baseline and after 150 min of each intervention. Circulating 3-OHB increased during 3-OHB infusion versus placebo in healthy control participants, with a similar increase in patients with T1D. In the control group, 3-OHB infusion increased cardiac output by 1.9 ± 0.4 L/min but only by 0.5 ± 0.1 L/min in patients with T1D. Stroke volume increased by 14 ± 5 mL and left ventricular (LV) ejection fraction by 3 ± 1 percentage points in healthy control participants; there was no change in these parameters in patients with T1D. During 3-OHB infusion in patients with T1D, LV global wasted work increased and LV global work efficiency decreased. In conclusion, patients with T1D had an abnormal cardiovascular response to 3-OHB infusion. Diabetic cardiomyopathy in patients may involve impaired cardiac ketone metabolism. Article Highlights The diabetic heart has reduced ketone utilization due to impaired ketolytic enzyme activity. In a randomized, controlled, crossover trial, we investigated whether the cardiac response to 3-hydroxybutyrate infusion is impaired in type 1 diabetes. The response on cardiac output was blunted by 80% in type 1 diabetes, with no improvement in systolic function and left ventricular work efficiency was reduced. These findings suggest impaired cardiac ketone metabolism may have clinical significance and could contribute to diabetic cardiomyopathy.","PeriodicalId":11376,"journal":{"name":"Diabetes","volume":"14 1","pages":""},"PeriodicalIF":7.7,"publicationDate":"2025-06-17","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144311307","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Dynamic Ca2+-Dependent Transcription Links Metabolic Stress to Impaired β-Cell Identity 动态Ca2+依赖性转录将代谢应激与β细胞身份受损联系起来
IF 7.7 1区 医学
Diabetes Pub Date : 2025-06-17 DOI: 10.2337/db24-1141
Anna B. Osipovich, Matthew T. Dickerson, Jean-Philippe Cartailler, Shristi Shrestha, Nicole M. Wright, David A. Jacobson, Mark A. Magnuson
{"title":"Dynamic Ca2+-Dependent Transcription Links Metabolic Stress to Impaired β-Cell Identity","authors":"Anna B. Osipovich, Matthew T. Dickerson, Jean-Philippe Cartailler, Shristi Shrestha, Nicole M. Wright, David A. Jacobson, Mark A. Magnuson","doi":"10.2337/db24-1141","DOIUrl":"https://doi.org/10.2337/db24-1141","url":null,"abstract":"By augmenting ATP-sensitive K+ channel–induced membrane depolarization, chronic metabolic stress in prediabetes may increase intracellular Ca2+ concentrations in pancreatic β-cells and cause a loss of cell identity and function. Here, we describe studies of the temporal transcriptomic dynamics induced by sulfonylurea-induced membrane depolarization. Gene expression in isolated islets is highly dynamic, with changes occurring within 30 min of membrane depolarization. Initially, the changes are adaptive and driven mainly by signaling through CREB and several other CREB-dependent transcription factors. However, within several hours, there is a progressive decline in islet function that correlates with the diminished expression of islet identity genes and the expression of dedifferentiation markers, consistent with the responses having become maladaptive. The gene expression adaptations cluster into 19 distinct response patterns driven by multiple transcription factors. We also identify a set of high-concentration glucose/Ca2+-regulated genes and modules of coexpressed genes that are enriched for type 2 diabetes risk genes. Together, these findings establish a close temporal link between membrane depolarization, changes in intracellular Ca2+ concentrations, alterations in the islet transcriptome, and impairments of β-cell identity and function. Article Highlights This study was undertaken to establish a temporal link between an increase in intracellular Ca2+ concentration and the loss of pancreatic β-cell identity. We profiled the alterations in Ca2+ dynamics and gene transcription that occur in freshly isolated islets following membrane depolarization. We show that initially adaptive Ca2+-dependent transcription changes, mediated largely by CREB and CREB-dependent transcription factors, rapidly become maladaptive, causing the loss of β-cell identity and function. We also show that many effector genes linked to nearby human type 2 diabetes susceptibility loci are regulated by Ca2+-dependent mechanisms.","PeriodicalId":11376,"journal":{"name":"Diabetes","volume":"10 1","pages":""},"PeriodicalIF":7.7,"publicationDate":"2025-06-17","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144311314","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
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