LIN ZHAO, DAN ZHU, DEXUE LIU, TIANRONG PAN, DONGJI WANG, YUAN HUI, HONGWEI LING, HANQIN CAI, MEIFANG ZENG, YUE ZUO, YUQI SUN, YIKE WANG, XIAOYING LI
Introduction: HRS9531, a novel dual GLP-1 and GIP receptor agonist, has shown prominent efficacy in glycemic control and weight loss in phase 1 trials. This phase 2 study evaluated the efficacy and safety of HRS9531 in obese adults without diabetes. Methods: In this randomized, double-blind, placebo-controlled phase 2 study, 249 Chinese adults with a BMI of 28-40 kg/m2 were randomized 1:1:1:1:1 to receive once-weekly subcutaneous injections of HRS9531 (1.0 mg, 3.0 mg, 4.5 mg, and 6.0 mg) or placebo for 24 weeks (24W). The primary endpoint was the percentage change in body weight at W24. Results: The least-squares mean percentage change in body weight from baseline at W24 was -5.4% (95% CI -7.3% to -3.5%), -13.4% (-15.2% to -11.5%), -14.0% (-15.9% to -12.1%), and -16.8% (-18.8% to -14.9%) in the 1.0 mg, 3.0 mg, 4.5 mg, and 6.0 mg groups, respectively, compared to -0.1% (-2.1% to 1.8%) in the placebo group (P<0.0001 for all comparisons with placebo). The proportion of participants achieving ≥5% body weight reduction was 52.0%, 88.2%, 92.0%, 91.8%, and 10.2%, respectively. Additionally, HRS9531 outperformed placebo in lowering blood pressure, improving glycemic control, and reducing triglyceride levels. The least-squares mean changes from baseline to W24 in systolic blood pressure ranged from -4.46 to -8.33 mmHg in the HRS9531 groups (placebo: -0.41 mmHg) and in the waist circumference ranged from -5.14 to -12.73 cm in the HRS9531 groups (placebo: -1.82 cm). Most adverse events (AEs) were mild or moderate in severity, and the most common AEs were nausea, diarrhea, decreased appetite, and vomiting, occurring primarily during dose escalation. No serious AEs were treatment-related and no participants discontinued treatment due to treatment-related AEs. Conclusion: HRS9531 effectively reduced body weight, blood pressure, blood glucose, and triglycerides, with a favorable safety profile. These data support further clinical development of HRS9531 for obesity treatment. Disclosure L. Zhao: None. D. Zhu: None. D. Liu: None. T. Pan: None. D. Wang: None. Y. Hui: None. H. Ling: None. H. Cai: None. M. Zeng: Employee; Jiangsu Hengrui Pharmaceuticals Co., Ltd. Y. Zuo: Employee; Jiangsu Hengrui Pharmaceuticals Co., Ltd. Y. Sun: Employee; Jiangsu Hengrui Pharmaceuticals Co., Ltd. Y. Wang: Employee; Jiangsu Hengrui Pharmaceuticals Co., Ltd. X. Li: None. Funding Jiangsu Hengrui Pharmaceuticals Co., Ltd.
{"title":"1861-LB: Efficacy and Safety of HRS9531, a Novel Dual GLP-1/GIP Receptor Agonist, in Obese Adults—A Phase 2 Trial","authors":"LIN ZHAO, DAN ZHU, DEXUE LIU, TIANRONG PAN, DONGJI WANG, YUAN HUI, HONGWEI LING, HANQIN CAI, MEIFANG ZENG, YUE ZUO, YUQI SUN, YIKE WANG, XIAOYING LI","doi":"10.2337/db24-1861-lb","DOIUrl":"https://doi.org/10.2337/db24-1861-lb","url":null,"abstract":"Introduction: HRS9531, a novel dual GLP-1 and GIP receptor agonist, has shown prominent efficacy in glycemic control and weight loss in phase 1 trials. This phase 2 study evaluated the efficacy and safety of HRS9531 in obese adults without diabetes. Methods: In this randomized, double-blind, placebo-controlled phase 2 study, 249 Chinese adults with a BMI of 28-40 kg/m2 were randomized 1:1:1:1:1 to receive once-weekly subcutaneous injections of HRS9531 (1.0 mg, 3.0 mg, 4.5 mg, and 6.0 mg) or placebo for 24 weeks (24W). The primary endpoint was the percentage change in body weight at W24. Results: The least-squares mean percentage change in body weight from baseline at W24 was -5.4% (95% CI -7.3% to -3.5%), -13.4% (-15.2% to -11.5%), -14.0% (-15.9% to -12.1%), and -16.8% (-18.8% to -14.9%) in the 1.0 mg, 3.0 mg, 4.5 mg, and 6.0 mg groups, respectively, compared to -0.1% (-2.1% to 1.8%) in the placebo group (P&lt;0.0001 for all comparisons with placebo). The proportion of participants achieving ≥5% body weight reduction was 52.0%, 88.2%, 92.0%, 91.8%, and 10.2%, respectively. Additionally, HRS9531 outperformed placebo in lowering blood pressure, improving glycemic control, and reducing triglyceride levels. The least-squares mean changes from baseline to W24 in systolic blood pressure ranged from -4.46 to -8.33 mmHg in the HRS9531 groups (placebo: -0.41 mmHg) and in the waist circumference ranged from -5.14 to -12.73 cm in the HRS9531 groups (placebo: -1.82 cm). Most adverse events (AEs) were mild or moderate in severity, and the most common AEs were nausea, diarrhea, decreased appetite, and vomiting, occurring primarily during dose escalation. No serious AEs were treatment-related and no participants discontinued treatment due to treatment-related AEs. Conclusion: HRS9531 effectively reduced body weight, blood pressure, blood glucose, and triglycerides, with a favorable safety profile. These data support further clinical development of HRS9531 for obesity treatment. Disclosure L. Zhao: None. D. Zhu: None. D. Liu: None. T. Pan: None. D. Wang: None. Y. Hui: None. H. Ling: None. H. Cai: None. M. Zeng: Employee; Jiangsu Hengrui Pharmaceuticals Co., Ltd. Y. Zuo: Employee; Jiangsu Hengrui Pharmaceuticals Co., Ltd. Y. Sun: Employee; Jiangsu Hengrui Pharmaceuticals Co., Ltd. Y. Wang: Employee; Jiangsu Hengrui Pharmaceuticals Co., Ltd. X. Li: None. Funding Jiangsu Hengrui Pharmaceuticals Co., Ltd.","PeriodicalId":11376,"journal":{"name":"Diabetes","volume":"70 1","pages":""},"PeriodicalIF":7.7,"publicationDate":"2024-06-21","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141448560","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}
MILIBETH CASTRO, DOUGLAS BISHOP, DENA WEITZMAN, RINA RAMIREZ
Diabetic eye disease (DED), specifically diabetic retinopathy (DR) and diabetic macular edema (DME), affects nearly 30 percent of people living with diabetes. Despite the severity of DED, almost half of those living with diabetes do not receive an annual eye exam for diabetes (EED) as recommended by leading professional societies. Zufall Health Center (ZHC), a Federally Qualified Health Center, faced a substantial care gap due to the high demand for annual EEDs surpassing the capacity of their onsite optometrist. In response, in April 2021, ZHC implemented an FDA-cleared autonomous artificial intelligence (AI) system for the detection of DR (including DME) into routine diabetes care. We investigated the impact of AI implementation on patient access to annual EEDs, assessing changes in completion rates before and after. Annual EEDs were defined as completion of an evaluation in the eye for DED by either an eyecare provider or autonomous AI. Completion rates for annual EEDs for patients with diabetes increased from 16.0% (314/1,904) (April 2021) to 35.0% (996/2,819) (June 2023), 529 of which were tested with autonomous AI. Between April 2021 to June 2023, 384 patients received a diagnosis from the autonomous AI. Among all patients examined by the autonomous AI, 24.0% (92/384) were identified as having signs of DED and received prompt referrals to eyecare. 292 patients tested negative, avoiding an unnecessary referral to eyecare. The integration of autonomous AI at the point of care effectively reduces access barriers, resulting in a substantial increase in DED testing rates. Disclosure M. Castro: None. D. Bishop: None. D. Weitzman: Employee; Digital Diagnostics. R. Ramirez: None.
{"title":"57-OR: Enhancing Diabetic Eye Disease Detection through Autonomous Artificial Intelligence Implementation in a Federally Qualified Health Center","authors":"MILIBETH CASTRO, DOUGLAS BISHOP, DENA WEITZMAN, RINA RAMIREZ","doi":"10.2337/db24-57-or","DOIUrl":"https://doi.org/10.2337/db24-57-or","url":null,"abstract":"Diabetic eye disease (DED), specifically diabetic retinopathy (DR) and diabetic macular edema (DME), affects nearly 30 percent of people living with diabetes. Despite the severity of DED, almost half of those living with diabetes do not receive an annual eye exam for diabetes (EED) as recommended by leading professional societies. Zufall Health Center (ZHC), a Federally Qualified Health Center, faced a substantial care gap due to the high demand for annual EEDs surpassing the capacity of their onsite optometrist. In response, in April 2021, ZHC implemented an FDA-cleared autonomous artificial intelligence (AI) system for the detection of DR (including DME) into routine diabetes care. We investigated the impact of AI implementation on patient access to annual EEDs, assessing changes in completion rates before and after. Annual EEDs were defined as completion of an evaluation in the eye for DED by either an eyecare provider or autonomous AI. Completion rates for annual EEDs for patients with diabetes increased from 16.0% (314/1,904) (April 2021) to 35.0% (996/2,819) (June 2023), 529 of which were tested with autonomous AI. Between April 2021 to June 2023, 384 patients received a diagnosis from the autonomous AI. Among all patients examined by the autonomous AI, 24.0% (92/384) were identified as having signs of DED and received prompt referrals to eyecare. 292 patients tested negative, avoiding an unnecessary referral to eyecare. The integration of autonomous AI at the point of care effectively reduces access barriers, resulting in a substantial increase in DED testing rates. Disclosure M. Castro: None. D. Bishop: None. D. Weitzman: Employee; Digital Diagnostics. R. Ramirez: None.","PeriodicalId":11376,"journal":{"name":"Diabetes","volume":"10 1","pages":""},"PeriodicalIF":7.7,"publicationDate":"2024-06-21","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141448649","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}
YUNWEN XU, MICHAEL FANG, JOSEF CORESH, MORGAN GRAMS, ELIZABETH SELVIN, JUNG-IM SHIN
Introduction & Objective: As data on medication use in type 1 diabetes (T1D) is scarce, we aimed to characterize trends in obesity and glucagon-like peptide-1 receptor agonists (GLP-1RA) use among US youth and adults with T1D from 2008-2022. Methods: We identified patients with T1D using a validated algorithm using deidentified electronic health record data from the Optum Labs Data Warehouse. Body mass index (BMI) categories were based on age- and sex-specific percentiles for youth (2-19 years) and WHO criteria for adults (≥20 years). We characterized trends in overweight and obesity, and GLP1-RA prescriptions by BMI categories from 2008-2010 to 2020-2022. Results: We included 159,879 patients with T1D (19% youth, mean age 39 years, 49% female, 77% non-Hispanic White). From 2008-2010 to 2020-2022, obesity in youth increased from 19% to 26% (P<.001), and severe obesity from 4% to 11% (P<.001) (Figure A). In adults, obesity rose from 28% in 2008-2010 to 37% in 2020-2022 (P<.001) (Figure B). There was a rapid uptake of GLP-1RA over the last 15 years, particularly in severe obesity (Figure C-D). In 2020-2022, GLP-1RA was used by 18% of youth and 34% of adults with severe obesity. Conclusion: Obesity has reached epidemic levels in patients with T1D. The off-label prescription of GLP-1RA significantly increased over time, especially in severe obesity. More data on GLP-1RA's effects in the T1D population is needed. Disclosure Y. Xu: None. M. Fang: None. J. Coresh: Consultant; SomaLogic, Healthy.io. M. Grams: None. E. Selvin: None. J. Shin: None.
{"title":"1438-P: Trends in Obesity and GLP-1RA Use among Youth and Adults with Type 1 Diabetes in U.S. Health System—2008–2022","authors":"YUNWEN XU, MICHAEL FANG, JOSEF CORESH, MORGAN GRAMS, ELIZABETH SELVIN, JUNG-IM SHIN","doi":"10.2337/db24-1438-p","DOIUrl":"https://doi.org/10.2337/db24-1438-p","url":null,"abstract":"Introduction & Objective: As data on medication use in type 1 diabetes (T1D) is scarce, we aimed to characterize trends in obesity and glucagon-like peptide-1 receptor agonists (GLP-1RA) use among US youth and adults with T1D from 2008-2022. Methods: We identified patients with T1D using a validated algorithm using deidentified electronic health record data from the Optum Labs Data Warehouse. Body mass index (BMI) categories were based on age- and sex-specific percentiles for youth (2-19 years) and WHO criteria for adults (≥20 years). We characterized trends in overweight and obesity, and GLP1-RA prescriptions by BMI categories from 2008-2010 to 2020-2022. Results: We included 159,879 patients with T1D (19% youth, mean age 39 years, 49% female, 77% non-Hispanic White). From 2008-2010 to 2020-2022, obesity in youth increased from 19% to 26% (P&lt;.001), and severe obesity from 4% to 11% (P&lt;.001) (Figure A). In adults, obesity rose from 28% in 2008-2010 to 37% in 2020-2022 (P&lt;.001) (Figure B). There was a rapid uptake of GLP-1RA over the last 15 years, particularly in severe obesity (Figure C-D). In 2020-2022, GLP-1RA was used by 18% of youth and 34% of adults with severe obesity. Conclusion: Obesity has reached epidemic levels in patients with T1D. The off-label prescription of GLP-1RA significantly increased over time, especially in severe obesity. More data on GLP-1RA's effects in the T1D population is needed. Disclosure Y. Xu: None. M. Fang: None. J. Coresh: Consultant; SomaLogic, Healthy.io. M. Grams: None. E. Selvin: None. J. Shin: None.","PeriodicalId":11376,"journal":{"name":"Diabetes","volume":"62 1","pages":""},"PeriodicalIF":7.7,"publicationDate":"2024-06-21","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141448473","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}
MICHAEL FANG, YUNWEN XU, JOSEF CORESH, SHOSHANA BALLEW, ELIZABETH SELVIN, JUNG-IM SHIN
Introduction: Continuous glucose monitoring (CGM) technology has revolutionized the management of type 1 diabetes. However, trends and disparities in CGM use remain poorly characterized in general type 1 diabetes population. Methods: We conducted a serial cross-sectional analysis of youth and adults with type 1 diabetes using de-identified electronic health record data from the Optum Labs Data Warehouse. Type 1 diabetes status was determined using a validated algorithm. Use of CGM was ascertained by National Drug Codes from prescription order data. We examined trends in CGM use from 2008-2010 to 2020-2022, overall and by age, sex, race/ethnicity, and insurance type. Results: We included 128,821 individuals with type 1 diabetes (17% under age 18 years; 48% female; 78% non-Hispanic White). From 2008-2010 to 2020-2022, the use of CGM increased from <1% to 47% in youth and 2% to 37% in adults with type 1 diabetes (Fig A1 and A2). Uptake of CGM was similar across age and sex, but substantially lower in racial/ethnic minority patients and those with Medicaid insurance (Fig B1-E2). Conclusion: Over the past 15 years, the use of CGM has grown significantly among persons with type 1 diabetes in the US. However, racial/ethnic and socioeconomic disparities have widened in both youth and adults. There is an urgent need to expand access to care and diabetes technology to improve care in this population. Disclosure M. Fang: None. Y. Xu: None. J. Coresh: Consultant; SomaLogic, Healthy.io. S. Ballew: None. E. Selvin: None. J. Shin: None. Funding K01 DK138273-01
{"title":"1444-P: Trends and Disparities in Continuous Glucose Monitoring Use in U.S. Youth and Adults with Type 1 Diabetes—2008–2022","authors":"MICHAEL FANG, YUNWEN XU, JOSEF CORESH, SHOSHANA BALLEW, ELIZABETH SELVIN, JUNG-IM SHIN","doi":"10.2337/db24-1444-p","DOIUrl":"https://doi.org/10.2337/db24-1444-p","url":null,"abstract":"Introduction: Continuous glucose monitoring (CGM) technology has revolutionized the management of type 1 diabetes. However, trends and disparities in CGM use remain poorly characterized in general type 1 diabetes population. Methods: We conducted a serial cross-sectional analysis of youth and adults with type 1 diabetes using de-identified electronic health record data from the Optum Labs Data Warehouse. Type 1 diabetes status was determined using a validated algorithm. Use of CGM was ascertained by National Drug Codes from prescription order data. We examined trends in CGM use from 2008-2010 to 2020-2022, overall and by age, sex, race/ethnicity, and insurance type. Results: We included 128,821 individuals with type 1 diabetes (17% under age 18 years; 48% female; 78% non-Hispanic White). From 2008-2010 to 2020-2022, the use of CGM increased from &lt;1% to 47% in youth and 2% to 37% in adults with type 1 diabetes (Fig A1 and A2). Uptake of CGM was similar across age and sex, but substantially lower in racial/ethnic minority patients and those with Medicaid insurance (Fig B1-E2). Conclusion: Over the past 15 years, the use of CGM has grown significantly among persons with type 1 diabetes in the US. However, racial/ethnic and socioeconomic disparities have widened in both youth and adults. There is an urgent need to expand access to care and diabetes technology to improve care in this population. Disclosure M. Fang: None. Y. Xu: None. J. Coresh: Consultant; SomaLogic, Healthy.io. S. Ballew: None. E. Selvin: None. J. Shin: None. Funding K01 DK138273-01","PeriodicalId":11376,"journal":{"name":"Diabetes","volume":"16 1","pages":""},"PeriodicalIF":7.7,"publicationDate":"2024-06-21","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141448532","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}
ZHIYI ZHU, YAO LI, GUO WANJUN, QING ZHENG, JIANHUI DENG, ERIC ADEGBITE, STEPHEN ROSS, LIBNIR TELUSCA, CATHERINE L. JONES, MARTIJN FENAUX, SUSAN XU, MOHAMMED K. JUNAIDI
Introduction & Objective: Ecnoglutide is a cAMP-biased, long-acting GLP-1RA being developed for the treatment of type 2 diabetes mellitus and obesity. Oral ecnoglutide (XW004) is formulated with an absorption enhancer, PNAC (T2026). The objective of this study was to evaluate the safety and tolerability of oral ecnoglutide in healthy adults. Methods: We conducted a randomized, double-blind, placebo-controlled Phase 1 study in healthy (Cohorts 1 to 3) and healthy obese (Cohort 4) adults. Participants (n = 56) were randomized to receive oral ecnoglutide at target doses of 7, 15, or 30 mg QD for up to 6 weeks, with dose escalation. Safety, tolerability, PK, and body weight were assessed. The results of Cohorts 1 to 4 are presented, the study is ongoing to evaluate additional dosing schemes. Results: Oral ecnoglutide was generally safe and well tolerated. The most common AEs were mild to moderate gastrointestinal events that occurred during dose escalation. There were no serious AEs. One participant experienced a Grade 3 AE of diarrhea that led to study drug discontinuation. At baseline, participants had a mean BMI of 25.8 to 26.1 kg/m2 (Cohorts 1 to 3) and 32.9 kg/m2 (Cohort 4). At end of treatment, participants in Cohorts 1 to 3 receiving up to 7, 15, or 30 mg QD oral ecnoglutide for 2 weeks had body weight change from baseline of -3.63, -3.38, and -6.55%, respectively vs -0.85% for placebo. Participants in Cohort 4 receiving up to 30 mg QD for 6 weeks had a body weight reduction of -6.76% vs -0.85% for placebo. At steady state, oral ecnoglutide 30 mg QD resulted in a plasma AUC0-24h of 12,470 h*ng/mL and calculated weekly AUC 0-168h of 87,290 h*ng/mL. Conclusion: Oral ecnoglutide was safe and well tolerated and resulted in pronounced weight loss after 6 weeks of dosing. Improved oral bioavailability enables a daily dose of 30 mg oral ecnoglutide to match or exceed the plasma exposure of weekly subcutaneous GLP-1 analogs. Oral ecnoglutide has a potential to be a best-in-class oral GLP-1RA. Disclosure Z. Zhu: None. Y. Li: Employee; Sciwind Biosciences. G. Wanjun: Employee; Sciwind Biosciences. Q. Zheng: Employee; Sciwind Biosciences. J. Deng: Employee; Sciwind Biosciences. E. Adegbite: Employee; Sciwind Biosciences. S. Ross: None. L. Telusca: None. C.L. Jones: Employee; Sciwind Biosciences. M. Fenaux: None. S. Xu: None. M.K. Junaidi: None. Funding Sciwind Biosciences
{"title":"1871-LB: Phase 1 Topline Safety, Efficacy, and Pharmacokinetics of Oral Ecnoglutide","authors":"ZHIYI ZHU, YAO LI, GUO WANJUN, QING ZHENG, JIANHUI DENG, ERIC ADEGBITE, STEPHEN ROSS, LIBNIR TELUSCA, CATHERINE L. JONES, MARTIJN FENAUX, SUSAN XU, MOHAMMED K. JUNAIDI","doi":"10.2337/db24-1871-lb","DOIUrl":"https://doi.org/10.2337/db24-1871-lb","url":null,"abstract":"Introduction & Objective: Ecnoglutide is a cAMP-biased, long-acting GLP-1RA being developed for the treatment of type 2 diabetes mellitus and obesity. Oral ecnoglutide (XW004) is formulated with an absorption enhancer, PNAC (T2026). The objective of this study was to evaluate the safety and tolerability of oral ecnoglutide in healthy adults. Methods: We conducted a randomized, double-blind, placebo-controlled Phase 1 study in healthy (Cohorts 1 to 3) and healthy obese (Cohort 4) adults. Participants (n = 56) were randomized to receive oral ecnoglutide at target doses of 7, 15, or 30 mg QD for up to 6 weeks, with dose escalation. Safety, tolerability, PK, and body weight were assessed. The results of Cohorts 1 to 4 are presented, the study is ongoing to evaluate additional dosing schemes. Results: Oral ecnoglutide was generally safe and well tolerated. The most common AEs were mild to moderate gastrointestinal events that occurred during dose escalation. There were no serious AEs. One participant experienced a Grade 3 AE of diarrhea that led to study drug discontinuation. At baseline, participants had a mean BMI of 25.8 to 26.1 kg/m2 (Cohorts 1 to 3) and 32.9 kg/m2 (Cohort 4). At end of treatment, participants in Cohorts 1 to 3 receiving up to 7, 15, or 30 mg QD oral ecnoglutide for 2 weeks had body weight change from baseline of -3.63, -3.38, and -6.55%, respectively vs -0.85% for placebo. Participants in Cohort 4 receiving up to 30 mg QD for 6 weeks had a body weight reduction of -6.76% vs -0.85% for placebo. At steady state, oral ecnoglutide 30 mg QD resulted in a plasma AUC0-24h of 12,470 h*ng/mL and calculated weekly AUC 0-168h of 87,290 h*ng/mL. Conclusion: Oral ecnoglutide was safe and well tolerated and resulted in pronounced weight loss after 6 weeks of dosing. Improved oral bioavailability enables a daily dose of 30 mg oral ecnoglutide to match or exceed the plasma exposure of weekly subcutaneous GLP-1 analogs. Oral ecnoglutide has a potential to be a best-in-class oral GLP-1RA. Disclosure Z. Zhu: None. Y. Li: Employee; Sciwind Biosciences. G. Wanjun: Employee; Sciwind Biosciences. Q. Zheng: Employee; Sciwind Biosciences. J. Deng: Employee; Sciwind Biosciences. E. Adegbite: Employee; Sciwind Biosciences. S. Ross: None. L. Telusca: None. C.L. Jones: Employee; Sciwind Biosciences. M. Fenaux: None. S. Xu: None. M.K. Junaidi: None. Funding Sciwind Biosciences","PeriodicalId":11376,"journal":{"name":"Diabetes","volume":"32 1","pages":""},"PeriodicalIF":7.7,"publicationDate":"2024-06-21","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141448690","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}
METTE BORBJERG, ANNIKA V. KVIST, KALA MEHTA, NIELS EJSKJAER, JENISE C. WONG
Introduction & Objective: The American Diabetes Association recommends continuous glucose monitoring (CGM) for all people with type 1 diabetes (T1D) as early as the time of diagnosis. CGM has been associated with reductions in HbA1c, and it has been recommended that CGM should be initiated within 12 months of diagnosis. We aimed to determine the impact of insurance and race/ethnicity on the timing of CGM initiation in children with T1D and to compare glycemic control in those initiating CGM within six months of diagnosis compared to later initiation. Methods: Children up to age 21 years followed at UCSF Benioff Children’s Hospital diagnosed with T1D between February 2015 and September 2021 were included (n = 270) and grouped according to time of CGM initiation. Analysis of insurance and race/ethnicity was done using one-way ANOVA or Kruskal Wallis H-test. T-test and Wilcoxon test were performed to compare early and late CGM initiation. Results: The median time from T1D diagnosis to CGM initiation was 6 months for publicly insured individuals compared to 2 months for privately insured individuals (p-value < 0.001), similar differences were found between individuals of racial or ethnic minority (minority) groups and individuals identified as white, non-Hispanic. Median HbA1c was 7.5% for children with time-of-initiation < 6 months; 8.4% for children with time-of-initiation > 6 months (p-value < 0.001). Conclusion: Publicly insured children and children of minority groups experience delays in starting recommended T1D treatment with CGM, with a longer time-to-initiation as compared to privately insured children and white, non-Hispanic children. This is of clinical importance, as more optimal glycemic control has been associated with earlier initiation of CGM. Barriers to CGM initiation may result in less optimal glycemic control for publicly insured children and children of minority groups with diabetes. Disclosure M. Borbjerg: None. K. Mehta: None. N. Ejskjaer: None. J.C. Wong: Research Support; Dexcom, Inc., Tandem Diabetes Care, Inc., Abbott.
{"title":"1910-LB: Disparities in Initiation of Continuous Glucose Monitoring and Impact on Glycemic Control in Children and Adolescents with Type 1 Diabetes","authors":"METTE BORBJERG, ANNIKA V. KVIST, KALA MEHTA, NIELS EJSKJAER, JENISE C. WONG","doi":"10.2337/db24-1910-lb","DOIUrl":"https://doi.org/10.2337/db24-1910-lb","url":null,"abstract":"Introduction & Objective: The American Diabetes Association recommends continuous glucose monitoring (CGM) for all people with type 1 diabetes (T1D) as early as the time of diagnosis. CGM has been associated with reductions in HbA1c, and it has been recommended that CGM should be initiated within 12 months of diagnosis. We aimed to determine the impact of insurance and race/ethnicity on the timing of CGM initiation in children with T1D and to compare glycemic control in those initiating CGM within six months of diagnosis compared to later initiation. Methods: Children up to age 21 years followed at UCSF Benioff Children’s Hospital diagnosed with T1D between February 2015 and September 2021 were included (n = 270) and grouped according to time of CGM initiation. Analysis of insurance and race/ethnicity was done using one-way ANOVA or Kruskal Wallis H-test. T-test and Wilcoxon test were performed to compare early and late CGM initiation. Results: The median time from T1D diagnosis to CGM initiation was 6 months for publicly insured individuals compared to 2 months for privately insured individuals (p-value &lt; 0.001), similar differences were found between individuals of racial or ethnic minority (minority) groups and individuals identified as white, non-Hispanic. Median HbA1c was 7.5% for children with time-of-initiation &lt; 6 months; 8.4% for children with time-of-initiation &gt; 6 months (p-value &lt; 0.001). Conclusion: Publicly insured children and children of minority groups experience delays in starting recommended T1D treatment with CGM, with a longer time-to-initiation as compared to privately insured children and white, non-Hispanic children. This is of clinical importance, as more optimal glycemic control has been associated with earlier initiation of CGM. Barriers to CGM initiation may result in less optimal glycemic control for publicly insured children and children of minority groups with diabetes. Disclosure M. Borbjerg: None. K. Mehta: None. N. Ejskjaer: None. J.C. Wong: Research Support; Dexcom, Inc., Tandem Diabetes Care, Inc., Abbott.","PeriodicalId":11376,"journal":{"name":"Diabetes","volume":"28 1","pages":""},"PeriodicalIF":7.7,"publicationDate":"2024-06-21","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141448638","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}
KENDA ALKWATLI, HUIJUN XIAO, ARSHIYA MARIAM, KEVIN M. PANTALONE, DANIEL M. ROTROFF
Objective: To assess whether real-world weight loss is associated with a modified risk of developing cancer. Methods:A retrospective observational study was conducted using the electronic health record at Cleveland Clinic (1/1/00-12/31/22). The primary endpoint was the development of 13 obesity-related cancers, and the secondary endpoint was the occurrence of 17 other types of cancer. The association between the % change in body mass index (BMI) 3, 5, and 10 year intervals prior to cancer diagnosis (for cases) vs. controls for each cancer endpoint was assessed using logistic regression models. Results:A total of 105,489 patients:100,162 controls and 5327 cases were identified. The % female was 43% and 52%, the % White was 84% and 78%, and median age (years) was 62 and 53, among cases and controls, respectively. Median BMI at censoring (kg/m2.) was 34.3 for cases and 34.5 for controls. Our results show reduced risk of developing obesity-related cancers with weight loss at 3 years (OR 0.99, 95%CI [0.984, 0.996]) and 5 years (OR 0.989,95% CI [0.983-0.995]), and for other types of cancer for all time intervals (ORs<1, P <0.001) (Figure 1a). The risk was reduced for renal cell carcinoma (3 years), multiple myeloma (10 years), and endometrial cancer (3& 5years) among primary cancer endpoints (P<0.05) (Figure 1b). Conclusion:A decrease in risk of developing obesity-related cancers and other types of cancer was associated with real-world weight loss. Disclosure K. Alkwatli: None. H. Xiao: None. A. Mariam: None. K.M. Pantalone: Speaker's Bureau; AstraZeneca. Consultant; AstraZeneca. Board Member; Bayer Inc. Research Support; Bayer Inc. Speaker's Bureau; Corcept Therapeutics. Consultant; Corcept Therapeutics, Diasome, Eli Lilly and Company, Merck & Co., Inc. Speaker's Bureau; Merck & Co., Inc. Research Support; Merck & Co., Inc. Consultant; Novo Nordisk. Research Support; Novo Nordisk. Speaker's Bureau; Novo Nordisk. Research Support; Twin Health. Consultant; Sanofi. D.M. Rotroff: Consultant; Novo Nordisk. Research Support; Bayer Inc.
{"title":"2071-LB: Reduced Risk of Obesity-Related Cancers with Real-World Weight Loss","authors":"KENDA ALKWATLI, HUIJUN XIAO, ARSHIYA MARIAM, KEVIN M. PANTALONE, DANIEL M. ROTROFF","doi":"10.2337/db24-2071-lb","DOIUrl":"https://doi.org/10.2337/db24-2071-lb","url":null,"abstract":"Objective: To assess whether real-world weight loss is associated with a modified risk of developing cancer. Methods:A retrospective observational study was conducted using the electronic health record at Cleveland Clinic (1/1/00-12/31/22). The primary endpoint was the development of 13 obesity-related cancers, and the secondary endpoint was the occurrence of 17 other types of cancer. The association between the % change in body mass index (BMI) 3, 5, and 10 year intervals prior to cancer diagnosis (for cases) vs. controls for each cancer endpoint was assessed using logistic regression models. Results:A total of 105,489 patients:100,162 controls and 5327 cases were identified. The % female was 43% and 52%, the % White was 84% and 78%, and median age (years) was 62 and 53, among cases and controls, respectively. Median BMI at censoring (kg/m2.) was 34.3 for cases and 34.5 for controls. Our results show reduced risk of developing obesity-related cancers with weight loss at 3 years (OR 0.99, 95%CI [0.984, 0.996]) and 5 years (OR 0.989,95% CI [0.983-0.995]), and for other types of cancer for all time intervals (ORs&lt;1, P &lt;0.001) (Figure 1a). The risk was reduced for renal cell carcinoma (3 years), multiple myeloma (10 years), and endometrial cancer (3& 5years) among primary cancer endpoints (P&lt;0.05) (Figure 1b). Conclusion:A decrease in risk of developing obesity-related cancers and other types of cancer was associated with real-world weight loss. Disclosure K. Alkwatli: None. H. Xiao: None. A. Mariam: None. K.M. Pantalone: Speaker's Bureau; AstraZeneca. Consultant; AstraZeneca. Board Member; Bayer Inc. Research Support; Bayer Inc. Speaker's Bureau; Corcept Therapeutics. Consultant; Corcept Therapeutics, Diasome, Eli Lilly and Company, Merck & Co., Inc. Speaker's Bureau; Merck & Co., Inc. Research Support; Merck & Co., Inc. Consultant; Novo Nordisk. Research Support; Novo Nordisk. Speaker's Bureau; Novo Nordisk. Research Support; Twin Health. Consultant; Sanofi. D.M. Rotroff: Consultant; Novo Nordisk. Research Support; Bayer Inc.","PeriodicalId":11376,"journal":{"name":"Diabetes","volume":"7 1","pages":""},"PeriodicalIF":7.7,"publicationDate":"2024-06-21","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141448653","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}
ANN-MARIE ROSLAND, GRETCHEN PIATT, EDITH C. KIEFFER, FELIX VALBUENA, GLORIA PALMISANO, DENISE J. DEVERTS, STEPHANIE PEREZ, JONATHAN YABES, CHRISTINA M. LALAMA, MICHELE HEISLER
Introduction: Family support can be crucial to sustaining gains from diabetes self-management education/support (DSMES), especially for low SES Hispanic adults with diabetes (AWD). DSMES lacks structured approaches to engaging support persons (SP). Our objective was to determine the effectiveness of FAM-ACT, a DSMES program focused on AWD-SP dyads vs DSMES with individual AWD, both CHW-delivered and tailored to Hispanic AWD. Methods: Adult patients with T2D and A1C ≥7.5% at an FQHC serving a Hispanic population were enrolled with an adult SP; dyads were randomized to FAM-ACT or DSMES, then invited to 6 sessions over 6 months. Each FAM-ACT session included SP training on supporting AWD diabetes management. AWD A1C was measured at baseline, 6 and 12 months. The primary outcome was 6-month change in A1C, analyzed using linear mixed models. Results: Among 222 AWD-SP dyads enrolled, AWD were mean age 52 years (SD 10), 38% men, 82% preferred Spanish language, 39% had a high school degree or more. SPs were mean age 45 (SD 13), 47% were the AWD’s spouse/partner, 26% adult child, and 27% sibling/friend/other. AWD completed mean 3.8/6 sessions, and SP in FAM-ACT arm 2.7/6. In ITT analyses, A1C 6-month decline was greater in DSMES than FAM-ACT (-0.97% vs. -0.42%, p=0.06) but at 12 months, they were similar (DSMES -0.55%, FAM-ACT -0.65%, p=0.77). In Complier Average Causal Effect (CACE) analyses based on AWD and SP with at least average expected session attendance, FAM-ACT 6 month A1C decline was -1.32% vs DSMES -0.89%, p=0.59 and at 12 months FAM-ACT had sustained decline (-1.23% vs -0.47% DSMES, p=0.63). Conclusion: FAM-ACT was less effective at lowering 6-month A1C than traditional DSMES among low SES Hispanic adults, however FAM-ACT A1C continued to improve 6 months after the program ended while traditional DSMES gains regressed. When supporters engaged with patients in FAM-ACT, AWD had clinically significantly larger improvements that were sustained. Disclosure A. Rosland: None. G. Piatt: None. E.C. Kieffer: None. F. Valbuena: None. G. Palmisano: None. S. Perez: None. J. Yabes: Other Relationship; Bayer Inc. M. Heisler: None. Funding National Institute of Diabetes and Digestive and Kidney Diseases (R01DK116733)
{"title":"1822-LB: Family Support for Diabetes Action (FAM-ACT) vs. Traditional Diabetes Management Education and Support—Randomized Comparative Effectiveness Trial","authors":"ANN-MARIE ROSLAND, GRETCHEN PIATT, EDITH C. KIEFFER, FELIX VALBUENA, GLORIA PALMISANO, DENISE J. DEVERTS, STEPHANIE PEREZ, JONATHAN YABES, CHRISTINA M. LALAMA, MICHELE HEISLER","doi":"10.2337/db24-1822-lb","DOIUrl":"https://doi.org/10.2337/db24-1822-lb","url":null,"abstract":"Introduction: Family support can be crucial to sustaining gains from diabetes self-management education/support (DSMES), especially for low SES Hispanic adults with diabetes (AWD). DSMES lacks structured approaches to engaging support persons (SP). Our objective was to determine the effectiveness of FAM-ACT, a DSMES program focused on AWD-SP dyads vs DSMES with individual AWD, both CHW-delivered and tailored to Hispanic AWD. Methods: Adult patients with T2D and A1C ≥7.5% at an FQHC serving a Hispanic population were enrolled with an adult SP; dyads were randomized to FAM-ACT or DSMES, then invited to 6 sessions over 6 months. Each FAM-ACT session included SP training on supporting AWD diabetes management. AWD A1C was measured at baseline, 6 and 12 months. The primary outcome was 6-month change in A1C, analyzed using linear mixed models. Results: Among 222 AWD-SP dyads enrolled, AWD were mean age 52 years (SD 10), 38% men, 82% preferred Spanish language, 39% had a high school degree or more. SPs were mean age 45 (SD 13), 47% were the AWD’s spouse/partner, 26% adult child, and 27% sibling/friend/other. AWD completed mean 3.8/6 sessions, and SP in FAM-ACT arm 2.7/6. In ITT analyses, A1C 6-month decline was greater in DSMES than FAM-ACT (-0.97% vs. -0.42%, p=0.06) but at 12 months, they were similar (DSMES -0.55%, FAM-ACT -0.65%, p=0.77). In Complier Average Causal Effect (CACE) analyses based on AWD and SP with at least average expected session attendance, FAM-ACT 6 month A1C decline was -1.32% vs DSMES -0.89%, p=0.59 and at 12 months FAM-ACT had sustained decline (-1.23% vs -0.47% DSMES, p=0.63). Conclusion: FAM-ACT was less effective at lowering 6-month A1C than traditional DSMES among low SES Hispanic adults, however FAM-ACT A1C continued to improve 6 months after the program ended while traditional DSMES gains regressed. When supporters engaged with patients in FAM-ACT, AWD had clinically significantly larger improvements that were sustained. Disclosure A. Rosland: None. G. Piatt: None. E.C. Kieffer: None. F. Valbuena: None. G. Palmisano: None. S. Perez: None. J. Yabes: Other Relationship; Bayer Inc. M. Heisler: None. Funding National Institute of Diabetes and Digestive and Kidney Diseases (R01DK116733)","PeriodicalId":11376,"journal":{"name":"Diabetes","volume":"21 1","pages":""},"PeriodicalIF":7.7,"publicationDate":"2024-06-21","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141448742","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}
Introduction: HbA1c target levels are often used as a treatment goal for patients with diabetes. Many recent studies indicate that HbA1c overestimates mean blood glucose (MBG) among Non-Hispanic Black (NHB) patients compared to Non-Hispanic White (NHW). We hypothesized that this disparity could be associated with greater risk of hypoglycemia in NHB patients especially where management is primarily based on a treat to HbA1c target. To assess this possibility we analyzed multiyear repeated-measures data from the Diabetes Control and Complications Trial (DCCT). Methods: Publicly available DCCT data was analyzed using mixed effects general linear modeling to evaluate the differences in HbA1c vs MBG for NWB (n=29) and NHW (n=1391) patients accounting for within patient correlation of HbA1c as well as MBG across multiple assessments. The model also controlled for age, diabetes duration, visit year and quarter, body mass index, study group and stratum. as well as interactive and nonlinear effects. Risk for severe hypoglycemia by ethnicity was separately determined. Results: Over the course of the DCCT, NHB pts had higher HbA1c than NHW patients at any given level of MBG, with greatest difference at lower MBG levels (p=0.001). The difference between groups in HbA1c by MBG adjusted for covariables was 0.51 at MBG of 150 mg/dl (p<0.03) and 0.39 at MBG of 450 mg/dl (p=0.09) Severe hypoglycemia increased with decreasing HbA1c. Relative risk for severe hypoglycemia for NHB was 1.92 compared to NHW (p=0.02). Conclusions: Among patients in the DCCT, HbA1c overpredicted MBG among NHB and was associated with greater risk for severe hypoglycemia. Predominant reliance on target HbA1c for management of diabetes may contribute to higher risk for hypoglycemia among NHB patients. Disclosure S. Chalew: None. R.J. McCarter: None. Funding National Intitutes of Health (1R21DK118643-O1A1)
{"title":"366-P: Mean Blood Glucose–Independent Racial Disparity in HbA1c and Higher Risk for Severe Hypoglycemia Is Evident among Participants in the Diabetes Control and Complications Trial","authors":"STUART CHALEW, ROBERT J. MCCARTER","doi":"10.2337/db24-366-p","DOIUrl":"https://doi.org/10.2337/db24-366-p","url":null,"abstract":"Introduction: HbA1c target levels are often used as a treatment goal for patients with diabetes. Many recent studies indicate that HbA1c overestimates mean blood glucose (MBG) among Non-Hispanic Black (NHB) patients compared to Non-Hispanic White (NHW). We hypothesized that this disparity could be associated with greater risk of hypoglycemia in NHB patients especially where management is primarily based on a treat to HbA1c target. To assess this possibility we analyzed multiyear repeated-measures data from the Diabetes Control and Complications Trial (DCCT). Methods: Publicly available DCCT data was analyzed using mixed effects general linear modeling to evaluate the differences in HbA1c vs MBG for NWB (n=29) and NHW (n=1391) patients accounting for within patient correlation of HbA1c as well as MBG across multiple assessments. The model also controlled for age, diabetes duration, visit year and quarter, body mass index, study group and stratum. as well as interactive and nonlinear effects. Risk for severe hypoglycemia by ethnicity was separately determined. Results: Over the course of the DCCT, NHB pts had higher HbA1c than NHW patients at any given level of MBG, with greatest difference at lower MBG levels (p=0.001). The difference between groups in HbA1c by MBG adjusted for covariables was 0.51 at MBG of 150 mg/dl (p&lt;0.03) and 0.39 at MBG of 450 mg/dl (p=0.09) Severe hypoglycemia increased with decreasing HbA1c. Relative risk for severe hypoglycemia for NHB was 1.92 compared to NHW (p=0.02). Conclusions: Among patients in the DCCT, HbA1c overpredicted MBG among NHB and was associated with greater risk for severe hypoglycemia. Predominant reliance on target HbA1c for management of diabetes may contribute to higher risk for hypoglycemia among NHB patients. Disclosure S. Chalew: None. R.J. McCarter: None. Funding National Intitutes of Health (1R21DK118643-O1A1)","PeriodicalId":11376,"journal":{"name":"Diabetes","volume":"2015 1","pages":""},"PeriodicalIF":7.7,"publicationDate":"2024-06-21","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141448446","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}
FRANCISCO J. PASQUEL, GEORGIA M. DAVIS, DAVID M. HUFFMAN, ANNE L. PETERS, JOHN C. PARKER, LORI M. LAFFEL, JUSTIN MATHEW, KRISTIN N. CASTORINO, DAVIDA F. KRUGER, KATHLEEN M. DUNGAN, MARK KIPNES, EDWARD JAUCH, TAMARA OSER, VIRAL N. SHAH, BARRY HOROWITZ, ANDERS L. CARLSON, MARK L. WARREN, WASIM DEEB, JOHN B. BUSE, JOHN H. REED, JASON BERNER, THOMAS BLEVINS, CHRIS BAJAJ, CRAIG KOLLMAN, DAN RAGHINARU, TRANG T. LY, ROY W. BECK, THE SECURE-T2D STUDY CONSORTIUM
Background: There is limited experience with automated insulin delivery (AID) in Type 2 Diabetes (T2D). Methods: We conducted a multicenter pivotal clinical trial to evaluate use of the Omnipod 5 AID System in a large diverse group of adults with T2D in the US. Adults aged 18-75y with T2D using insulin (basal-bolus, premix, or basal-only) who had screening HbA1c <12.0% were enrolled. Non-insulin agents were continued throughout. After a 14-day standard therapy phase to capture baseline glycemic management, participants initiated 13 weeks of AID. The primary endpoint was change in HbA1c from baseline to 13 weeks. Study completion occurred on March 1, 2024. Results: A total of 305 adults with T2D (mean age 57±11 years, 24% Black, 22% Hispanic/Latino) were enrolled in the study and initiated AID. Basal-bolus insulin delivery was being used by 79%, basal-only by 21%, GLP-1 receptor analogs by 55%, and SGLT1 or 2 inhibitors by 44%. Following 13 weeks of Omnipod 5 use, HbA1c decreased from 8.2±1.3% at baseline to 7.4±0.9% at study end (treatment effect= -0.8%, 95% CI: -1.0 to -0.7, p<0.001). The benefit of AID was greatest in those with the highest baseline HbA1c (Figure). Conclusion: These pivotal trial results demonstrate the substantial benefit of the Omnipod 5 AID System in a large diverse group of adults with T2D. Clinical trial registration: NCT05815342 Disclosure F.J. Pasquel: Research Support; Tandem Diabetes Care, Inc., Insulet Corporation, Dexcom, Inc., Ideal Medical Technologies, Novo Nordisk. Consultant; Dexcom, Inc., Medscape. G. Davis: Research Support; Insulet Corporation. Consultant; Medscape. A.L. Peters: Advisory Panel; Lilly Diabetes, Vertex Pharmaceuticals Incorporated, Medscape. Research Support; Abbott, Insulet Corporation. J.C. Parker: Speaker's Bureau; Novo Nordisk, Corcept Therapeutics, Insulet Corporation. L.M. Laffel: Consultant; Dexcom, Inc. Advisory Panel; Medscape, Medtronic, Vertex Pharmaceuticals Incorporated. Consultant; Novo Nordisk. Advisory Panel; Lilly Diabetes, Provention Bio, Inc., Sanofi-Aventis U.S., Janssen Pharmaceuticals, Inc., MannKind Corporation. J. Mathew: None. K.N. Castorino: Research Support; Abbott, Dexcom, Inc. Speaker's Bureau; Dexcom, Inc. Research Support; Lilly Diabetes, Medtronic, MannKind Corporation, Insulet Corporation. Consultant; Medscape. D.F. Kruger: Advisory Panel; Abbott. Research Support; Beta Bionics, Inc., Carmot Therapeutics, Inc. Speaker's Bureau; Dexcom, Inc. Advisory Panel; Dexcom, Inc., Lilly Diabetes. Speaker's Bureau; Lilly Diabetes. Advisory Panel; Insulet Corporation. Research Support; Insulet Corporation. Advisory Panel; MannKind Corporation, Novo Nordisk. Speaker's Bureau; Novo Nordisk. Research Support; Novo Nordisk. Advisory Panel; Provention Bio, Inc. Speaker's Bureau; Sanofi, Xeris Pharmaceuticals, Inc. Advisory Panel; Pendulum Therapeutics. Research Support; Tandem Diabetes Care, Inc. Advisory Panel; Cequr. Speaker's Bureau; Cequr. Advisory Panel; Medtro
{"title":"1904-LB: Glycemic Improvement with Use of the Omnipod 5 Automated Insulin Delivery System in Adults with Type 2 Diabetes—Results of the SECURE-T2D Pivotal Trial","authors":"FRANCISCO J. PASQUEL, GEORGIA M. DAVIS, DAVID M. HUFFMAN, ANNE L. PETERS, JOHN C. PARKER, LORI M. LAFFEL, JUSTIN MATHEW, KRISTIN N. CASTORINO, DAVIDA F. KRUGER, KATHLEEN M. DUNGAN, MARK KIPNES, EDWARD JAUCH, TAMARA OSER, VIRAL N. SHAH, BARRY HOROWITZ, ANDERS L. CARLSON, MARK L. WARREN, WASIM DEEB, JOHN B. BUSE, JOHN H. REED, JASON BERNER, THOMAS BLEVINS, CHRIS BAJAJ, CRAIG KOLLMAN, DAN RAGHINARU, TRANG T. LY, ROY W. BECK, THE SECURE-T2D STUDY CONSORTIUM","doi":"10.2337/db24-1904-lb","DOIUrl":"https://doi.org/10.2337/db24-1904-lb","url":null,"abstract":"Background: There is limited experience with automated insulin delivery (AID) in Type 2 Diabetes (T2D). Methods: We conducted a multicenter pivotal clinical trial to evaluate use of the Omnipod 5 AID System in a large diverse group of adults with T2D in the US. Adults aged 18-75y with T2D using insulin (basal-bolus, premix, or basal-only) who had screening HbA1c &lt;12.0% were enrolled. Non-insulin agents were continued throughout. After a 14-day standard therapy phase to capture baseline glycemic management, participants initiated 13 weeks of AID. The primary endpoint was change in HbA1c from baseline to 13 weeks. Study completion occurred on March 1, 2024. Results: A total of 305 adults with T2D (mean age 57±11 years, 24% Black, 22% Hispanic/Latino) were enrolled in the study and initiated AID. Basal-bolus insulin delivery was being used by 79%, basal-only by 21%, GLP-1 receptor analogs by 55%, and SGLT1 or 2 inhibitors by 44%. Following 13 weeks of Omnipod 5 use, HbA1c decreased from 8.2±1.3% at baseline to 7.4±0.9% at study end (treatment effect= -0.8%, 95% CI: -1.0 to -0.7, p&lt;0.001). The benefit of AID was greatest in those with the highest baseline HbA1c (Figure). Conclusion: These pivotal trial results demonstrate the substantial benefit of the Omnipod 5 AID System in a large diverse group of adults with T2D. Clinical trial registration: NCT05815342 Disclosure F.J. Pasquel: Research Support; Tandem Diabetes Care, Inc., Insulet Corporation, Dexcom, Inc., Ideal Medical Technologies, Novo Nordisk. Consultant; Dexcom, Inc., Medscape. G. Davis: Research Support; Insulet Corporation. Consultant; Medscape. A.L. Peters: Advisory Panel; Lilly Diabetes, Vertex Pharmaceuticals Incorporated, Medscape. Research Support; Abbott, Insulet Corporation. J.C. Parker: Speaker's Bureau; Novo Nordisk, Corcept Therapeutics, Insulet Corporation. L.M. Laffel: Consultant; Dexcom, Inc. Advisory Panel; Medscape, Medtronic, Vertex Pharmaceuticals Incorporated. Consultant; Novo Nordisk. Advisory Panel; Lilly Diabetes, Provention Bio, Inc., Sanofi-Aventis U.S., Janssen Pharmaceuticals, Inc., MannKind Corporation. J. Mathew: None. K.N. Castorino: Research Support; Abbott, Dexcom, Inc. Speaker's Bureau; Dexcom, Inc. Research Support; Lilly Diabetes, Medtronic, MannKind Corporation, Insulet Corporation. Consultant; Medscape. D.F. Kruger: Advisory Panel; Abbott. Research Support; Beta Bionics, Inc., Carmot Therapeutics, Inc. Speaker's Bureau; Dexcom, Inc. Advisory Panel; Dexcom, Inc., Lilly Diabetes. Speaker's Bureau; Lilly Diabetes. Advisory Panel; Insulet Corporation. Research Support; Insulet Corporation. Advisory Panel; MannKind Corporation, Novo Nordisk. Speaker's Bureau; Novo Nordisk. Research Support; Novo Nordisk. Advisory Panel; Provention Bio, Inc. Speaker's Bureau; Sanofi, Xeris Pharmaceuticals, Inc. Advisory Panel; Pendulum Therapeutics. Research Support; Tandem Diabetes Care, Inc. Advisory Panel; Cequr. Speaker's Bureau; Cequr. Advisory Panel; Medtro","PeriodicalId":11376,"journal":{"name":"Diabetes","volume":"5 1","pages":""},"PeriodicalIF":7.7,"publicationDate":"2024-06-21","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141448544","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}
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