SATISH K. GARG, IRL B. HIRSCH, ENRICO REPETTO, BRIAN ULMER, CHRISTOPHER PERKINS, JANET K. SNELL-BERGEON, RICHARD M. BERGENSTAL
Introduction & Objectives: While the benefits of CGM use in T1D are well documented, its efficacy across the spectrum of T2D patients in real-world settings has not been evaluated. We assessed the effects of CGM use in a large T2D adult population across the treatment spectrum, considering non-insulin therapies (NIT), basal insulin (BIT), and prandial insulin (PIT) with/without non-insulin medications. Methods: This retrospective,12-month analysis used data from a large claims database that included >7.1 million patients with T2D in the electronic medical records. The two observation periods were: pre-index period -- 360 days prior to patients' first CGM claim; and post-index period -- 360 days after to the first CGM claim. The index date (baseline) was the date of the first CGM claim between December 27, 2019, and January 5, 2022. The primary outcome was change in HbA1c closest to 12 months after CGM acquisition. Results: The analysis included 16,410 adults with T2D (NIT, n=4,659; (BIT, n=6,182, and PIT, n=5,569) with mean baseline HbA1c 8.8% and mean age 59 years. At 12 months, the mean change in HbA1c was significant in all three subgroups compared with HbA1c levels in the pre-index period. (Figure) Conclusions: In this 12-month, real-world study, CGM use was associated with significant improvements in glucose control in both non-insulin and insulin-treated patients with T2D. Disclosure S.K. Garg: Research Support; Eli Lilly and Company. Advisory Panel; Medtronic. Research Support; Medtronic. Advisory Panel; Novo Nordisk. Research Support; DarioHealth Corp., Dexcom, Inc., Diasome. Advisory Panel; Roche Diabetes Care. I.B. Hirsch: Advisory Panel; Abbott. Research Support; Dexcom, Inc. Advisory Panel; Roche Diabetes Care. Research Support; MannKind Corporation, Tandem Diabetes Care, Inc. Advisory Panel; embecta. Research Support; Tandem Diabetes Care, Inc. Advisory Panel; Vertex Pharmaceuticals Incorporated. E. Repetto: Employee; Roche Diabetes Care. B. Ulmer: Employee; Roche Diabetes Care. C. Perkins: Employee; Roche Diabetes Care. J.K. Snell-Bergeon: None. R.M. Bergenstal: Other Relationship; Abbott. Research Support; Arkray Marketing. Consultant; Ascensia Diabetes Care, Bigfoot Biomedical, Inc., CeQur. Other Relationship; Dexcom, Inc., Eli Lilly and Company. Consultant; embecta, Hygieia. Research Support; Insulet Corporation. Consultant; MannKind Corporation. Other Relationship; Medtronic, Novo Nordisk. Consultant; Onduo LLC, Roche Diabetes Care. Other Relationship; Sanofi. Research Support; Tandem Diabetes Care, Inc. Other Relationship; UnitedHealth Group. Consultant; Vertex Pharmaceuticals Incorporated, Zealand Pharma A/S. Funding Roche Diabetes Care
{"title":"355-OR: Glycemic Outcomes with CGM Use in Patients with Type 2 Diabetes—Real-World Analysis","authors":"SATISH K. GARG, IRL B. HIRSCH, ENRICO REPETTO, BRIAN ULMER, CHRISTOPHER PERKINS, JANET K. SNELL-BERGEON, RICHARD M. BERGENSTAL","doi":"10.2337/db24-355-or","DOIUrl":"https://doi.org/10.2337/db24-355-or","url":null,"abstract":"Introduction & Objectives: While the benefits of CGM use in T1D are well documented, its efficacy across the spectrum of T2D patients in real-world settings has not been evaluated. We assessed the effects of CGM use in a large T2D adult population across the treatment spectrum, considering non-insulin therapies (NIT), basal insulin (BIT), and prandial insulin (PIT) with/without non-insulin medications. Methods: This retrospective,12-month analysis used data from a large claims database that included >7.1 million patients with T2D in the electronic medical records. The two observation periods were: pre-index period -- 360 days prior to patients' first CGM claim; and post-index period -- 360 days after to the first CGM claim. The index date (baseline) was the date of the first CGM claim between December 27, 2019, and January 5, 2022. The primary outcome was change in HbA1c closest to 12 months after CGM acquisition. Results: The analysis included 16,410 adults with T2D (NIT, n=4,659; (BIT, n=6,182, and PIT, n=5,569) with mean baseline HbA1c 8.8% and mean age 59 years. At 12 months, the mean change in HbA1c was significant in all three subgroups compared with HbA1c levels in the pre-index period. (Figure) Conclusions: In this 12-month, real-world study, CGM use was associated with significant improvements in glucose control in both non-insulin and insulin-treated patients with T2D. Disclosure S.K. Garg: Research Support; Eli Lilly and Company. Advisory Panel; Medtronic. Research Support; Medtronic. Advisory Panel; Novo Nordisk. Research Support; DarioHealth Corp., Dexcom, Inc., Diasome. Advisory Panel; Roche Diabetes Care. I.B. Hirsch: Advisory Panel; Abbott. Research Support; Dexcom, Inc. Advisory Panel; Roche Diabetes Care. Research Support; MannKind Corporation, Tandem Diabetes Care, Inc. Advisory Panel; embecta. Research Support; Tandem Diabetes Care, Inc. Advisory Panel; Vertex Pharmaceuticals Incorporated. E. Repetto: Employee; Roche Diabetes Care. B. Ulmer: Employee; Roche Diabetes Care. C. Perkins: Employee; Roche Diabetes Care. J.K. Snell-Bergeon: None. R.M. Bergenstal: Other Relationship; Abbott. Research Support; Arkray Marketing. Consultant; Ascensia Diabetes Care, Bigfoot Biomedical, Inc., CeQur. Other Relationship; Dexcom, Inc., Eli Lilly and Company. Consultant; embecta, Hygieia. Research Support; Insulet Corporation. Consultant; MannKind Corporation. Other Relationship; Medtronic, Novo Nordisk. Consultant; Onduo LLC, Roche Diabetes Care. Other Relationship; Sanofi. Research Support; Tandem Diabetes Care, Inc. Other Relationship; UnitedHealth Group. Consultant; Vertex Pharmaceuticals Incorporated, Zealand Pharma A/S. Funding Roche Diabetes Care","PeriodicalId":11376,"journal":{"name":"Diabetes","volume":"20 1","pages":""},"PeriodicalIF":7.7,"publicationDate":"2024-06-24","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141448569","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}
Objective: To implement CGM and remotely monitor patients with T2D treated in a safety net clinic to allow for patient outreach between routinely scheduled visits and provide feedback to health care providers (HCP’s) for algorithm-based medication management. Methods: Patients were provided a Libre 2 CGM and followed via LibreView. Baseline clinical data and AGP’s were evaluated by the PI and management recommendations were sent to the patient’s HCP. Project staff reviewed the LibreView portal daily and contacted subjects who had glucose values either above 250 mg/dl or below 70 mg/dl more than 5% of the time and provide diabetes education. Clinical data updates and AGPs were sent to the PI based on need (from weekly to monthly) so additional diabetes management recommendations could be provided. Measures administered at baseline, 6 months and 12 months were assessed for Shapiro-Wilk normality and paired dependent t-tests. A 2-sided alpha of 0.05 was used. Results: Interim results of 137 of 200 enrolled subjects (52 not on insulin and 85 on insulin) showed improvements in the following measures from baseline to 6 months: Mean baseline A1C = 9.0% decreased to 7.8% by 6 months (-1.2 +/- 1.7 (SD), p<.001). TIR mean increase was 12.5 +/- 27.7 (SD), p<.001. GMI was reduced by -.591 +/- .59, p<.001. A slight reduction in depression was seen -0.847 +/- 4.6 (PHQ8, p= .036). Diabetes Distress Scale (DDS) showed reduced stress for non-insulin users -1.23 +/- 3.5, p= .012 and for insulin users -2.8 +/- 4.6, p = .005. HCPs implemented recommendations 75% of the time and use of GLP-1 RA’s doubled, based on recommendations sent to HCP’s. Analysis of 91 subjects who completed 12 months show sustained outcomes. Conclusions: Remote monitoring coupled with education and medication recommendations provided to HCPs improved diabetes outcomes in people with T2D, on insulin and non-insulin therapies. Disclosure V.F. Ruelas: None. A.L. Peters: Advisory Panel; Lilly Diabetes, Vertex Pharmaceuticals Incorporated, Medscape. Research Support; Abbott, Insulet Corporation.
{"title":"358-OR: Remote CGM Monitoring in People with Type 2 Diabetes (T2D) in an Under-resourced Setting","authors":"VALERIE F. RUELAS, ANNE L. PETERS","doi":"10.2337/db24-358-or","DOIUrl":"https://doi.org/10.2337/db24-358-or","url":null,"abstract":"Objective: To implement CGM and remotely monitor patients with T2D treated in a safety net clinic to allow for patient outreach between routinely scheduled visits and provide feedback to health care providers (HCP’s) for algorithm-based medication management. Methods: Patients were provided a Libre 2 CGM and followed via LibreView. Baseline clinical data and AGP’s were evaluated by the PI and management recommendations were sent to the patient’s HCP. Project staff reviewed the LibreView portal daily and contacted subjects who had glucose values either above 250 mg/dl or below 70 mg/dl more than 5% of the time and provide diabetes education. Clinical data updates and AGPs were sent to the PI based on need (from weekly to monthly) so additional diabetes management recommendations could be provided. Measures administered at baseline, 6 months and 12 months were assessed for Shapiro-Wilk normality and paired dependent t-tests. A 2-sided alpha of 0.05 was used. Results: Interim results of 137 of 200 enrolled subjects (52 not on insulin and 85 on insulin) showed improvements in the following measures from baseline to 6 months: Mean baseline A1C = 9.0% decreased to 7.8% by 6 months (-1.2 +/- 1.7 (SD), p&lt;.001). TIR mean increase was 12.5 +/- 27.7 (SD), p&lt;.001. GMI was reduced by -.591 +/- .59, p&lt;.001. A slight reduction in depression was seen -0.847 +/- 4.6 (PHQ8, p= .036). Diabetes Distress Scale (DDS) showed reduced stress for non-insulin users -1.23 +/- 3.5, p= .012 and for insulin users -2.8 +/- 4.6, p = .005. HCPs implemented recommendations 75% of the time and use of GLP-1 RA’s doubled, based on recommendations sent to HCP’s. Analysis of 91 subjects who completed 12 months show sustained outcomes. Conclusions: Remote monitoring coupled with education and medication recommendations provided to HCPs improved diabetes outcomes in people with T2D, on insulin and non-insulin therapies. Disclosure V.F. Ruelas: None. A.L. Peters: Advisory Panel; Lilly Diabetes, Vertex Pharmaceuticals Incorporated, Medscape. Research Support; Abbott, Insulet Corporation.","PeriodicalId":11376,"journal":{"name":"Diabetes","volume":"84 1","pages":""},"PeriodicalIF":7.7,"publicationDate":"2024-06-24","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141448683","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}
LOUIS ARONNE, M. SCOTT HARRIS, M S. ROBERTS, JOHN J. SUSCHAK, SHAHEEN TOMAH, JONATHAN KASPER, LIANG HE, JAY YANG, JUAN P. FRIAS, SARAH K. BROWNE
Introduction & Objective: Pemvidutide is a GLP-1/glucagon dual receptor agonist in development for treatment of obesity. Methods: MOMENTUM was a Phase 2, randomized, placebo-controlled trial of subjects with overweight (BMI 27.0-29.9 kg/m2) and at least one obesity-related comorbidity or obesity (BMI >30.0 kg/m2) randomized 1:1:1:1 to pemvidutide (1.2, 1.8, 2.4 mg) or placebo administered subcutaneously weekly for 48 weeks. Results: A total of 391 subjects with mean age, body weight, and BMI of 50 yrs, 105 kg, and 37 kg/m2 were enrolled. At week 48, subjects receiving pemvidutide achieved mean weight losses of 10.3%, 11.2%, and 15.6% at the 1.2 mg, 1.8 mg, and 2.4 mg doses vs. placebo (2.2%), respectively (p<0.001 vs. placebo, all doses, Figure 1), with 51.8% and 32.1% of subjects at the 2.4 mg dose level achieving ≥15% and ≥20% weight loss and 48% of subjects having resolution of baseline obesity by trial conclusion. Subjects with elevated serum lipids at baseline had reductions of up to 55.8%, 20.0%, and 21.8% in triglycerides, total cholesterol and LDL at week 48. Most adverse events were mild to moderate with only 1 drug-related SAE; glycemic control (glucose, HbA1c) was maintained with minimal increases in heart rate. Conclusion: Pemvidutide was safe and well-tolerated and significantly reduced body weight and serum lipids over 48 weeks of treatment. Disclosure L. Aronne: Advisory Panel; Novo Nordisk. Consultant; Novo Nordisk. Advisory Panel; Lilly Diabetes, Altimmune Inc. Consultant; Lilly Diabetes. Advisory Panel; Pfizer Inc. Consultant; UnitedHealth Group. Advisory Panel; Boehringer-Ingelheim. Board Member; AstraZeneca. Advisory Panel; Amgen Inc. M. Harris: Employee; Altimmune Inc. M.S. Roberts: Employee; Altimmune Inc. J.J. Suschak: Employee; Altimmune Inc. S. Tomah: Employee; Altimmune Inc. J. Kasper: Employee; Altimmune Inc. L. He: None. J. Yang: None. J.P. Frias: Research Support; Akero Therapeutics, Inc. Consultant; Akero Therapeutics, Inc. Research Support; Altimmune Inc. Consultant; Altimmune Inc. Research Support; Boehringer-Ingelheim. Consultant; Boehringer-Ingelheim. Research Support; 89bio, Inc. Consultant; 89bio, Inc. Research Support; Eli Lilly and Company. Advisory Panel; Eli Lilly and Company. Speaker's Bureau; Eli Lilly and Company. Research Support; Merck & Co., Inc. Consultant; Merck & Co., Inc. Research Support; Novartis Pharmaceuticals Corporation. Consultant; Novartis Pharmaceuticals Corporation, Novo Nordisk. Board Member; Novo Nordisk. Research Support; Novo Nordisk, Pfizer Inc. Consultant; Pfizer Inc. Advisory Panel; Sanofi. Speaker's Bureau; Sanofi. Research Support; Sanofi. Stock/Shareholder; Biomea Fusion, Inc. Employee; Biomea Fusion, Inc. S.K. Browne: Employee; Altimmune Inc.
{"title":"262-OR: Pemvidutide, a GLP-1/Glucagon Dual Receptor Agonist, in Subjects with Overweight or Obesity—A 48-Week, Placebo-Controlled, Phase 2 (MOMENTUM) Trial","authors":"LOUIS ARONNE, M. SCOTT HARRIS, M S. ROBERTS, JOHN J. SUSCHAK, SHAHEEN TOMAH, JONATHAN KASPER, LIANG HE, JAY YANG, JUAN P. FRIAS, SARAH K. BROWNE","doi":"10.2337/db24-262-or","DOIUrl":"https://doi.org/10.2337/db24-262-or","url":null,"abstract":"Introduction & Objective: Pemvidutide is a GLP-1/glucagon dual receptor agonist in development for treatment of obesity. Methods: MOMENTUM was a Phase 2, randomized, placebo-controlled trial of subjects with overweight (BMI 27.0-29.9 kg/m2) and at least one obesity-related comorbidity or obesity (BMI &gt;30.0 kg/m2) randomized 1:1:1:1 to pemvidutide (1.2, 1.8, 2.4 mg) or placebo administered subcutaneously weekly for 48 weeks. Results: A total of 391 subjects with mean age, body weight, and BMI of 50 yrs, 105 kg, and 37 kg/m2 were enrolled. At week 48, subjects receiving pemvidutide achieved mean weight losses of 10.3%, 11.2%, and 15.6% at the 1.2 mg, 1.8 mg, and 2.4 mg doses vs. placebo (2.2%), respectively (p&lt;0.001 vs. placebo, all doses, Figure 1), with 51.8% and 32.1% of subjects at the 2.4 mg dose level achieving ≥15% and ≥20% weight loss and 48% of subjects having resolution of baseline obesity by trial conclusion. Subjects with elevated serum lipids at baseline had reductions of up to 55.8%, 20.0%, and 21.8% in triglycerides, total cholesterol and LDL at week 48. Most adverse events were mild to moderate with only 1 drug-related SAE; glycemic control (glucose, HbA1c) was maintained with minimal increases in heart rate. Conclusion: Pemvidutide was safe and well-tolerated and significantly reduced body weight and serum lipids over 48 weeks of treatment. Disclosure L. Aronne: Advisory Panel; Novo Nordisk. Consultant; Novo Nordisk. Advisory Panel; Lilly Diabetes, Altimmune Inc. Consultant; Lilly Diabetes. Advisory Panel; Pfizer Inc. Consultant; UnitedHealth Group. Advisory Panel; Boehringer-Ingelheim. Board Member; AstraZeneca. Advisory Panel; Amgen Inc. M. Harris: Employee; Altimmune Inc. M.S. Roberts: Employee; Altimmune Inc. J.J. Suschak: Employee; Altimmune Inc. S. Tomah: Employee; Altimmune Inc. J. Kasper: Employee; Altimmune Inc. L. He: None. J. Yang: None. J.P. Frias: Research Support; Akero Therapeutics, Inc. Consultant; Akero Therapeutics, Inc. Research Support; Altimmune Inc. Consultant; Altimmune Inc. Research Support; Boehringer-Ingelheim. Consultant; Boehringer-Ingelheim. Research Support; 89bio, Inc. Consultant; 89bio, Inc. Research Support; Eli Lilly and Company. Advisory Panel; Eli Lilly and Company. Speaker's Bureau; Eli Lilly and Company. Research Support; Merck & Co., Inc. Consultant; Merck & Co., Inc. Research Support; Novartis Pharmaceuticals Corporation. Consultant; Novartis Pharmaceuticals Corporation, Novo Nordisk. Board Member; Novo Nordisk. Research Support; Novo Nordisk, Pfizer Inc. Consultant; Pfizer Inc. Advisory Panel; Sanofi. Speaker's Bureau; Sanofi. Research Support; Sanofi. Stock/Shareholder; Biomea Fusion, Inc. Employee; Biomea Fusion, Inc. S.K. Browne: Employee; Altimmune Inc.","PeriodicalId":11376,"journal":{"name":"Diabetes","volume":"46 1","pages":""},"PeriodicalIF":7.7,"publicationDate":"2024-06-23","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141448618","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}
REBEKAH J. WALKER, SEBASTIAN LINDE, LEONARD E. EGEDE
Structural racism is known to influence diabetes outcomes; however, there is limited understanding of potential pathways for the relationship. Given the importance of access to healthy food for adults at risk for diabetes, this study investigated food access as a possible pathway between structural racism and diabetes prevalence at a census tract level. A national dataset of 11,457 census tracts across 201 counties, within 38 states was used for the analysis. Prevalence of diabetes in each census tract was based on CDC PLACES data. Structural racism was defined as historic residential redlining using Home Owners’ Loan Corporation (HOLC) residential security maps from the Mapping Inequality project (higher scores indicate more redlining). Food access was defined using the modified retail food environment index (mRFEI) calculated for each census tract as the number of healthy food retailers divided by the number of both healthy and less healthy food retailers (higher mRFEI scores indicate better food access). Direct and indirect relationships between redlining and diabetes prevalence via food access was investigated using structural equation modeling run in Stata v17, controlling for population of each census tract. Mean prevalence of diabetes was 11.8. Redlining (0.22, p<0.001) and lower food access (-0.11, p<0.001) were directly associated with higher prevalence of diabetes. Redlining was indirectly associated with diabetes via food access (-0.10, p<0.001). Based on these findings, structural racism is associated with higher diabetes prevalence via decreased food access at a census tract level. Interventions to improve access to healthy food options at the community level may help address the impact of structural racism on the health of individuals, particularly those at risk for diabetes living in historically redlined neighborhoods. Disclosure R.J. Walker: None. S. Linde: None. L.E. Egede: None. Funding National Institutes of Health (R01DK118038, R01DK120861, R01MD013826, R01MD017574, R01MD018012)
{"title":"209-OR: Direct and Indirect Effects of Redlining on Diabetes Prevalence via Food Access","authors":"REBEKAH J. WALKER, SEBASTIAN LINDE, LEONARD E. EGEDE","doi":"10.2337/db24-209-or","DOIUrl":"https://doi.org/10.2337/db24-209-or","url":null,"abstract":"Structural racism is known to influence diabetes outcomes; however, there is limited understanding of potential pathways for the relationship. Given the importance of access to healthy food for adults at risk for diabetes, this study investigated food access as a possible pathway between structural racism and diabetes prevalence at a census tract level. A national dataset of 11,457 census tracts across 201 counties, within 38 states was used for the analysis. Prevalence of diabetes in each census tract was based on CDC PLACES data. Structural racism was defined as historic residential redlining using Home Owners’ Loan Corporation (HOLC) residential security maps from the Mapping Inequality project (higher scores indicate more redlining). Food access was defined using the modified retail food environment index (mRFEI) calculated for each census tract as the number of healthy food retailers divided by the number of both healthy and less healthy food retailers (higher mRFEI scores indicate better food access). Direct and indirect relationships between redlining and diabetes prevalence via food access was investigated using structural equation modeling run in Stata v17, controlling for population of each census tract. Mean prevalence of diabetes was 11.8. Redlining (0.22, p&lt;0.001) and lower food access (-0.11, p&lt;0.001) were directly associated with higher prevalence of diabetes. Redlining was indirectly associated with diabetes via food access (-0.10, p&lt;0.001). Based on these findings, structural racism is associated with higher diabetes prevalence via decreased food access at a census tract level. Interventions to improve access to healthy food options at the community level may help address the impact of structural racism on the health of individuals, particularly those at risk for diabetes living in historically redlined neighborhoods. Disclosure R.J. Walker: None. S. Linde: None. L.E. Egede: None. Funding National Institutes of Health (R01DK118038, R01DK120861, R01MD013826, R01MD017574, R01MD018012)","PeriodicalId":11376,"journal":{"name":"Diabetes","volume":"43 1","pages":""},"PeriodicalIF":7.7,"publicationDate":"2024-06-22","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141448614","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}
PETER CALHOUN, CHARLEY SPANBAUER, ANDREA STECK, BRIGITTE I. FROHNERT, MARK A. HERMAN, BART KEYMEULEN, RIITTA VEIJOLA, JORMA TOPPARI, ASTER DESOUTER, FRANS K. GORUS, MARK A. ATKINSON, DARRELL M. WILSON, SUSAN PIETROPAOLO, ROY BECK
Introduction & Objective: We assessed if continuous glucose monitoring (CGM) metrics accurately identify imminent stage 3 T1D diagnosis in those with islet autoantibody (IAb) positivity. Methods: Baseline CGM data were collected from participants with ≥1 positive IAb type from five studies: ASK (N=79), BDR (N=22), DAISY (N=18), DIPP (N=8), and TrialNet (N=91). Median follow-up time was 2.6 y (IQR: 1.5 to 3.6 y). A CGM and baseline factor model and a baseline-only model were compared. CGM model classified participants as low (N=97), medium (N=74), or high (N=47) risk of stage 3 T1D based on <10%, 10-<30%, and ≥30% probability by year 2. Results: CGM model found % time >140 mg/dL (TA140), area under the curve 140 mg/dL (AUC140), glucose SD, sex, first degree relative, IA2A, and GADA status were more predictive of T1D progression compared to the baseline-only model (C-statistic: 0.76 vs. 0.62). The probability of developing T1D by 2 years was 4%, 17%, and 51% in the low, medium, and high risk groups (Figure). Compared to low risk participants, high risk participants had higher TA140 (median: 10% vs 2%), AUC140 (mean: 2.9 vs. 1.1 mg/dL), and glucose SD (mean: 24 vs. 18 mg/dL). Conclusion: CGM metrics can help predict T1D progression and classify participant’s risk of impending T1D diagnosis. CGM can be used to better monitor the risk of T1D progression and define eligibility for potential prevention trials. Disclosure P. Calhoun: None. C. Spanbauer: None. A. Steck: None. B.I. Frohnert: None. M.A. Herman: Research Support; Eli Lilly and Company. B. Keymeulen: None. R. Veijola: Advisory Panel; Sanofi. J. Toppari: None. A. Desouter: None. F.K. Gorus: None. M.A. Atkinson: None. D.M. Wilson: Advisory Panel; Enable Biosciences, Inc. S. Pietropaolo: None. R. Beck: Consultant; Insulet Corporation. Research Support; Insulet Corporation. Consultant; Tandem Diabetes Care, Inc. Research Support; Tandem Diabetes Care, Inc. Consultant; Beta Bionics, Inc. Research Support; Beta Bionics, Inc., Dexcom, Inc., Bigfoot Biomedical, Inc. Consultant; Novo Nordisk. Research Support; Novo Nordisk, Eli Lilly and Company. Consultant; embecta, Vertex Pharmaceuticals Incorporated, Hagar, Ypsomed AG, Sanofi, Zucara Therapeutics, Sequel. Funding JDRF
{"title":"74-OR: ADA Presidents' Select Abstract: CGM Metrics from Five Studies Identify Participants at High Risk of Imminent Type 1 Diabetes (T1D) Development","authors":"PETER CALHOUN, CHARLEY SPANBAUER, ANDREA STECK, BRIGITTE I. FROHNERT, MARK A. HERMAN, BART KEYMEULEN, RIITTA VEIJOLA, JORMA TOPPARI, ASTER DESOUTER, FRANS K. GORUS, MARK A. ATKINSON, DARRELL M. WILSON, SUSAN PIETROPAOLO, ROY BECK","doi":"10.2337/db24-74-or","DOIUrl":"https://doi.org/10.2337/db24-74-or","url":null,"abstract":"Introduction & Objective: We assessed if continuous glucose monitoring (CGM) metrics accurately identify imminent stage 3 T1D diagnosis in those with islet autoantibody (IAb) positivity. Methods: Baseline CGM data were collected from participants with ≥1 positive IAb type from five studies: ASK (N=79), BDR (N=22), DAISY (N=18), DIPP (N=8), and TrialNet (N=91). Median follow-up time was 2.6 y (IQR: 1.5 to 3.6 y). A CGM and baseline factor model and a baseline-only model were compared. CGM model classified participants as low (N=97), medium (N=74), or high (N=47) risk of stage 3 T1D based on &lt;10%, 10-&lt;30%, and ≥30% probability by year 2. Results: CGM model found % time &gt;140 mg/dL (TA140), area under the curve 140 mg/dL (AUC140), glucose SD, sex, first degree relative, IA2A, and GADA status were more predictive of T1D progression compared to the baseline-only model (C-statistic: 0.76 vs. 0.62). The probability of developing T1D by 2 years was 4%, 17%, and 51% in the low, medium, and high risk groups (Figure). Compared to low risk participants, high risk participants had higher TA140 (median: 10% vs 2%), AUC140 (mean: 2.9 vs. 1.1 mg/dL), and glucose SD (mean: 24 vs. 18 mg/dL). Conclusion: CGM metrics can help predict T1D progression and classify participant’s risk of impending T1D diagnosis. CGM can be used to better monitor the risk of T1D progression and define eligibility for potential prevention trials. Disclosure P. Calhoun: None. C. Spanbauer: None. A. Steck: None. B.I. Frohnert: None. M.A. Herman: Research Support; Eli Lilly and Company. B. Keymeulen: None. R. Veijola: Advisory Panel; Sanofi. J. Toppari: None. A. Desouter: None. F.K. Gorus: None. M.A. Atkinson: None. D.M. Wilson: Advisory Panel; Enable Biosciences, Inc. S. Pietropaolo: None. R. Beck: Consultant; Insulet Corporation. Research Support; Insulet Corporation. Consultant; Tandem Diabetes Care, Inc. Research Support; Tandem Diabetes Care, Inc. Consultant; Beta Bionics, Inc. Research Support; Beta Bionics, Inc., Dexcom, Inc., Bigfoot Biomedical, Inc. Consultant; Novo Nordisk. Research Support; Novo Nordisk, Eli Lilly and Company. Consultant; embecta, Vertex Pharmaceuticals Incorporated, Hagar, Ypsomed AG, Sanofi, Zucara Therapeutics, Sequel. Funding JDRF","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":"141448463","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}
ELIF TAMA, DIMA BECHENATI, PAMELA BENNETT, ALLYSON MCNALLY, RENE RIVERA, SIMA FANSA, DIEGO ANAZCO, ANDRES ACOSTA, MARIA D. HURTADO
Introduction: The efficacy and safety of tirzepatide for the treatment of overweight/obesity are well established in adults with type 2, but not type 1, diabetes (T1D). We aim to evaluate the efficacy and safety of tirzepatide for the treatment of obesity in adults with T1D. Methods: This is a retrospective study of adults with T1D treated with tirzepatide for obesity. Exclusion criteria: tirzepatide use for <3 months, use of other antiobesity medications, and active malignancy. Endpoints: total body weight loss (TBWL) percentage at 3, 6, and 12 months of treatment; TBWL%, change in HbA1c, total daily insulin dose [TDD], and continuous glucose monitor parameters (time in-, above-, and below range [TIR, TAR, and TBR, respectively]) from baseline to last-follow-up; and incidence of side effects, severe hypoglycemia, and diabetes ketoacidosis (DKA). We used matched pair t-test to analyze data. Data are presented as median [IQR]. Results: We included 52 patients: 58% female, 98% White, age 50 years [39-58], BMI 36 kg/m2 [32-42]. TBWL at 3, 6, and 12 months was 6% [3-9] (n=44), 8% [5-15] (n=29), and 14% [7-22] (n=13), respectively (p<0.001 for all). From baseline to the last follow up, median time of 6 months [4-11], TBWL% decreased by 8% [5-14], Hba1c by 1% [0.2-1.8], TDD by 32% [6-45], and TAR by 28% [8-48], p<0.001 for all. TIR increased by 29% [3-55], p<0.001. There was a trend for a decrease in TBR of 32% [0-78], p=0.08. No episodes of severe hypoglycemia or DKA were recorded. The incidence of side effects was 26%, the most common was nausea (15%). Two patients (4%) discontinued tirzepatide due to side effects. Conclusion: In adults with T1D, tirzepatide led to significant weight loss, better diabetes control, and lower insulin requirements without causing severe hypoglycemia or DKA over the course of up to 12 months. The side effect profile mimicked what has been reported. These data support the effectiveness and safety of tirzepatide for the treatment of obesity in adults with T1D. Disclosure E. Tama: None. D. Bechenati: None. P. Bennett: Stock/Shareholder; Lilly Diabetes. A. McNally: Stock/Shareholder; Medtronic. R. Rivera: None. S. Fansa: None. D. Anazco: None. A. Acosta: Consultant; Amgen Inc., Regeneron Pharmaceuticals Inc., Nestlé Health Science, Structure Therapeutics, Inc., Boehringer-Ingelheim. Research Support; Vivus. Consultant; Currax. Other Relationship; Gila Therapeutics, Phenomix Sciences. Speaker's Bureau; Eli Lilly and Company. M.D. Hurtado: None. Funding K12AR084222
{"title":"1660-P: Efficacy and Safety of Tirzepatide for the Treatment of Obesity in Adults with Type 1 Diabetes—The Mayo Clinic Experience","authors":"ELIF TAMA, DIMA BECHENATI, PAMELA BENNETT, ALLYSON MCNALLY, RENE RIVERA, SIMA FANSA, DIEGO ANAZCO, ANDRES ACOSTA, MARIA D. HURTADO","doi":"10.2337/db24-1660-p","DOIUrl":"https://doi.org/10.2337/db24-1660-p","url":null,"abstract":"Introduction: The efficacy and safety of tirzepatide for the treatment of overweight/obesity are well established in adults with type 2, but not type 1, diabetes (T1D). We aim to evaluate the efficacy and safety of tirzepatide for the treatment of obesity in adults with T1D. Methods: This is a retrospective study of adults with T1D treated with tirzepatide for obesity. Exclusion criteria: tirzepatide use for &lt;3 months, use of other antiobesity medications, and active malignancy. Endpoints: total body weight loss (TBWL) percentage at 3, 6, and 12 months of treatment; TBWL%, change in HbA1c, total daily insulin dose [TDD], and continuous glucose monitor parameters (time in-, above-, and below range [TIR, TAR, and TBR, respectively]) from baseline to last-follow-up; and incidence of side effects, severe hypoglycemia, and diabetes ketoacidosis (DKA). We used matched pair t-test to analyze data. Data are presented as median [IQR]. Results: We included 52 patients: 58% female, 98% White, age 50 years [39-58], BMI 36 kg/m2 [32-42]. TBWL at 3, 6, and 12 months was 6% [3-9] (n=44), 8% [5-15] (n=29), and 14% [7-22] (n=13), respectively (p&lt;0.001 for all). From baseline to the last follow up, median time of 6 months [4-11], TBWL% decreased by 8% [5-14], Hba1c by 1% [0.2-1.8], TDD by 32% [6-45], and TAR by 28% [8-48], p&lt;0.001 for all. TIR increased by 29% [3-55], p&lt;0.001. There was a trend for a decrease in TBR of 32% [0-78], p=0.08. No episodes of severe hypoglycemia or DKA were recorded. The incidence of side effects was 26%, the most common was nausea (15%). Two patients (4%) discontinued tirzepatide due to side effects. Conclusion: In adults with T1D, tirzepatide led to significant weight loss, better diabetes control, and lower insulin requirements without causing severe hypoglycemia or DKA over the course of up to 12 months. The side effect profile mimicked what has been reported. These data support the effectiveness and safety of tirzepatide for the treatment of obesity in adults with T1D. Disclosure E. Tama: None. D. Bechenati: None. P. Bennett: Stock/Shareholder; Lilly Diabetes. A. McNally: Stock/Shareholder; Medtronic. R. Rivera: None. S. Fansa: None. D. Anazco: None. A. Acosta: Consultant; Amgen Inc., Regeneron Pharmaceuticals Inc., Nestlé Health Science, Structure Therapeutics, Inc., Boehringer-Ingelheim. Research Support; Vivus. Consultant; Currax. Other Relationship; Gila Therapeutics, Phenomix Sciences. Speaker's Bureau; Eli Lilly and Company. M.D. Hurtado: None. Funding K12AR084222","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":"141448466","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: The coronavirus disease 2019 (COVID-19) is caused by the Severe Acute Respiratory Syndrome Coronavirus-2 (SARS-CoV-2). We hypothesized that SARS-CoV-2 could trigger loss of glucose homeostasis by compromising microvascular function in the pancreas. Methods: We incubated living pancreas slices from 7 non-diabetic human donors (from nPOD) with SARS-CoV-2 Spike S1 recombinant protein (SARS-Spike; 80 nM, 5xEC50, 1h). As a control, we incubated slices with a Spike S1 protein from HCoV-OC43. By confocal microscopy, we monitored the acute effects of these Spike S1 proteins on pericyte [Ca2+]i responses and vasomotion (capillaries labeled with fluorescent lectin). Using an ELISA assay, we assessed the effect of Spike S1 proteins on the endogenous levels of angiotensin II and angiotensin 1-7 in the supernatant of human pancreas slices. Results: Acute incubation with SARS-Spike led to closure of capillaries in human islets in living slices. We then stimulated slices with angiotensin II (100 nM; for 4 min) in 3 mM glucose solution. While islet capillaries in slices incubated with HCoV-OC43 constricted upon Angiotensin II application (~14% average reduction in diameter), vessels in slices treated with SARS-Spike did not further respond to Angiotensin II stimulation. In addition, incubation with SARS-Spike decreased the stimulatory effect of Angiotensin II on islet pericyte cytosolic calcium levels. Incubation with SARS-Spike slightly increased the levels of Angiotensin II produced by living pancreas slices while there was no difference in Angiotensin1-7 concentration. Conclusion: Our data indicate that the potential infection of vascular cells by SARS-CoV-2 could interfere with pericytes’ contractile properties and compromise capillary responses. We will determine in the future whether these changes are associated with an inhibition of ACE2 and/or a reduction of its expression at the plasma membrane. Disclosure C. Barboza: None. L. Mateus Goncalves: None. J. Almaca: None. Funding National Institutes of Health (R01DK133483)
导言冠状病毒病 2019（COVID-19）是由严重急性呼吸系统综合征冠状病毒-2（SARS-CoV-2）引起的。我们假设，SARS-CoV-2 可通过损害胰腺微血管功能引发葡萄糖稳态丧失。研究方法我们用 SARS-CoV-2 Spike S1 重组蛋白（SARS-Spike；80 nM，5xEC50，1 小时）培养来自 7 名非糖尿病人类供体（来自 nPOD）的活体胰腺切片。作为对照，我们用来自 HCoV-OC43 的 Spike S1 蛋白培养切片。通过共聚焦显微镜，我们监测了这些 Spike S1 蛋白对周皮[Ca2+]i 反应和血管运动（用荧光凝集素标记的毛细血管）的急性影响。通过酶联免疫吸附试验，我们评估了 Spike S1 蛋白对人胰腺切片上清液中血管紧张素 II 和血管紧张素 1-7 内源性水平的影响。实验结果用 SARS-Spike 急性孵育可导致活体切片中人胰岛毛细血管的关闭。然后，我们在 3 mM 葡萄糖溶液中用血管紧张素 II（100 nM，持续 4 分钟）刺激切片。用 HCoV-OC43 培养的切片中的胰岛毛细血管在血管紧张素 II 的作用下收缩（直径平均缩小约 14%），而用 SARS-Spike 处理的切片中的血管对血管紧张素 II 的刺激没有进一步反应。此外，用 SARS-Spike 培养可降低血管紧张素 II 对胰岛周细胞钙水平的刺激作用。用 SARS-Spike 培养可使活体胰腺切片产生的血管紧张素 II 水平略有增加，而血管紧张素 1-7 的浓度则没有差异。结论我们的数据表明，SARS-CoV-2 对血管细胞的潜在感染可能会干扰周细胞的收缩特性并损害毛细血管反应。我们将在未来确定这些变化是否与 ACE2 受抑制和/或其在质膜上的表达减少有关。披露 C. Barboza：无。L. Mateus Goncalves：无：无。J. Almaca：无：无。资助 美国国立卫生研究院（R01DK133483）
{"title":"2095-LB: Impact of SARS-CoV-2 Spike Proteins on the Islet Microvascular Function","authors":"CATARINA BARBOZA, LUCIANA MATEUS GONCALVES, JOANA ALMACA","doi":"10.2337/db24-2095-lb","DOIUrl":"https://doi.org/10.2337/db24-2095-lb","url":null,"abstract":"Introduction: The coronavirus disease 2019 (COVID-19) is caused by the Severe Acute Respiratory Syndrome Coronavirus-2 (SARS-CoV-2). We hypothesized that SARS-CoV-2 could trigger loss of glucose homeostasis by compromising microvascular function in the pancreas. Methods: We incubated living pancreas slices from 7 non-diabetic human donors (from nPOD) with SARS-CoV-2 Spike S1 recombinant protein (SARS-Spike; 80 nM, 5xEC50, 1h). As a control, we incubated slices with a Spike S1 protein from HCoV-OC43. By confocal microscopy, we monitored the acute effects of these Spike S1 proteins on pericyte [Ca2+]i responses and vasomotion (capillaries labeled with fluorescent lectin). Using an ELISA assay, we assessed the effect of Spike S1 proteins on the endogenous levels of angiotensin II and angiotensin 1-7 in the supernatant of human pancreas slices. Results: Acute incubation with SARS-Spike led to closure of capillaries in human islets in living slices. We then stimulated slices with angiotensin II (100 nM; for 4 min) in 3 mM glucose solution. While islet capillaries in slices incubated with HCoV-OC43 constricted upon Angiotensin II application (~14% average reduction in diameter), vessels in slices treated with SARS-Spike did not further respond to Angiotensin II stimulation. In addition, incubation with SARS-Spike decreased the stimulatory effect of Angiotensin II on islet pericyte cytosolic calcium levels. Incubation with SARS-Spike slightly increased the levels of Angiotensin II produced by living pancreas slices while there was no difference in Angiotensin1-7 concentration. Conclusion: Our data indicate that the potential infection of vascular cells by SARS-CoV-2 could interfere with pericytes’ contractile properties and compromise capillary responses. We will determine in the future whether these changes are associated with an inhibition of ACE2 and/or a reduction of its expression at the plasma membrane. Disclosure C. Barboza: None. L. Mateus Goncalves: None. J. Almaca: None. Funding National Institutes of Health (R01DK133483)","PeriodicalId":11376,"journal":{"name":"Diabetes","volume":"36 1","pages":""},"PeriodicalIF":7.7,"publicationDate":"2024-06-21","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141448488","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 & Objective: Increased reports of thoughts of suicide and self-harm among users of glucagon-like peptide-1 receptor agonists (GLP-1 RAs) have prompted multiple regulatory agencies to conduct reviews on the drug class. There is an urgent need to assess the safety of these drugs in a real-world setting. We sought to determine whether GLP-1 RA use is associated with an increased risk of suicide and self-harm when compared with dipeptidyl peptidase-4 (DPP-4) inhibitors among patients with type 2 diabetes. Methods: Using primary care, hospitalization and mortality data from the United Kingdom, we assembled a cohort of patients with type 2 diabetes newly prescribed GLP-1 RAs or DPP-4 inhibitors between January 2007 and December 2020. We used propensity score fine stratification weighting to balance the exposure groups on over 40 potential confounders, including age, sex, smoking, BMI, history of mental health disorders and behaviours associated with self-harm and suicide attempt, socioeconomic status, proxies for diabetes severity, common comorbidities, other medication use, and markers of health-seeking behaviour. Patients were followed using an on-treatment exposure definition. We fit weighted Cox proportional hazards models to estimate hazard ratios (HRs) and 95% confidence intervals (CIs) for incident suicide or self-harm. Results: The cohort included 36,083 new users of GLP-1 RAs and 234,186 new users of DPP-4 inhibitors. Crude analyses indicated a twofold increase in the risk of suicide and self-harm associated with GLP-1 RA use (HR 1.99, 95% CI 1.65-2.41); however, the weighted model showed no increased risk (HR 0.99, 95% CI 0.77-1.29). Conclusions: The use of GLP-1 RAs was not associated with an increased risk of suicide or self-harm in this large, population-based study from the United Kingdom. Increased reporting of thoughts of suicide and self-harm are likely due to confounding factors rather than a causal relationship. Disclosure S. Shapiro: None. L. Azoulay: Advisory Panel; Pfizer Inc. Consultant; Roche Diagnostics. H. Yin: None. O. Yu: None. S. Rej: Other Relationship; AbbVie Inc. Stock/Shareholder; Aifred Health. S. Suissa: Consultant; Boehringer-Ingelheim, Novartis Canada. Speaker's Bureau; Covispharma. Consultant; AtaraBio. Speaker's Bureau; Merck & Co., Inc. Consultant; Panalgo. Funding Canadian Institutes of Health Research (FDN-143328)
{"title":"1862-LB: Glucagon-Like Peptide 1 Receptor Agonists and the Risk of Suicide and Self-Harm among Patients with Type 2 Diabetes","authors":"SAMANTHA SHAPIRO, LAURENT AZOULAY, HUI YIN, ORIANA HOI YUN YU, SOHAM REJ, SAMY SUISSA","doi":"10.2337/db24-1862-lb","DOIUrl":"https://doi.org/10.2337/db24-1862-lb","url":null,"abstract":"Introduction & Objective: Increased reports of thoughts of suicide and self-harm among users of glucagon-like peptide-1 receptor agonists (GLP-1 RAs) have prompted multiple regulatory agencies to conduct reviews on the drug class. There is an urgent need to assess the safety of these drugs in a real-world setting. We sought to determine whether GLP-1 RA use is associated with an increased risk of suicide and self-harm when compared with dipeptidyl peptidase-4 (DPP-4) inhibitors among patients with type 2 diabetes. Methods: Using primary care, hospitalization and mortality data from the United Kingdom, we assembled a cohort of patients with type 2 diabetes newly prescribed GLP-1 RAs or DPP-4 inhibitors between January 2007 and December 2020. We used propensity score fine stratification weighting to balance the exposure groups on over 40 potential confounders, including age, sex, smoking, BMI, history of mental health disorders and behaviours associated with self-harm and suicide attempt, socioeconomic status, proxies for diabetes severity, common comorbidities, other medication use, and markers of health-seeking behaviour. Patients were followed using an on-treatment exposure definition. We fit weighted Cox proportional hazards models to estimate hazard ratios (HRs) and 95% confidence intervals (CIs) for incident suicide or self-harm. Results: The cohort included 36,083 new users of GLP-1 RAs and 234,186 new users of DPP-4 inhibitors. Crude analyses indicated a twofold increase in the risk of suicide and self-harm associated with GLP-1 RA use (HR 1.99, 95% CI 1.65-2.41); however, the weighted model showed no increased risk (HR 0.99, 95% CI 0.77-1.29). Conclusions: The use of GLP-1 RAs was not associated with an increased risk of suicide or self-harm in this large, population-based study from the United Kingdom. Increased reporting of thoughts of suicide and self-harm are likely due to confounding factors rather than a causal relationship. Disclosure S. Shapiro: None. L. Azoulay: Advisory Panel; Pfizer Inc. Consultant; Roche Diagnostics. H. Yin: None. O. Yu: None. S. Rej: Other Relationship; AbbVie Inc. Stock/Shareholder; Aifred Health. S. Suissa: Consultant; Boehringer-Ingelheim, Novartis Canada. Speaker's Bureau; Covispharma. Consultant; AtaraBio. Speaker's Bureau; Merck & Co., Inc. Consultant; Panalgo. Funding Canadian Institutes of Health Research (FDN-143328)","PeriodicalId":11376,"journal":{"name":"Diabetes","volume":"45 1","pages":""},"PeriodicalIF":7.7,"publicationDate":"2024-06-21","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141448571","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}
LINONG JI, WEI CHEN, RUIHUA DONG, MINGXIA YUAN, DONG ZHAO, SHUGUANG PANG, LIYUAN ZHAO, JING ZHAO, ZHONG-RU GAN
It remains unclear whether the superior efficacy of multi-target incretin analogs versus single-target incretins in obesity treatment. This randomized, double-blind, placebo-controlled, dose-escalation phase Ib/IIa study aimed to assess the efficacy and safety of a GLP-1 analog, GZR18, in Chinese adults with obesity. The study investigated the weight loss potential of GZR18 and evaluated the feasibility of administrating GZR18 at different frequencies. Thirty-six participants with obesity were randomized 3:1 to receive 30 mg of GZR18 or a placebo for 35 weeks, including a 31-week dose-escalation period. Upon dose escalation to 9 mg/week, subjects were divided into dosing sub-cohorts of QW or Q2W. Endpoints were body weight change and AEs incidence. The average weight loss of GZR18 adjusted by placebo was 18.6% in QW group and 13.5% in Q2W group, with no IP-related serious AEs. Gastrointestinal AEs were reported most frequently, mainly in early dose-escalation period. GZR18 reduced body weight robustly and improved metabolic profiles in study participants. Its weight-loss effects surpassed those of Semaglutide (2.4 mg) and Tirzepatide (15 mg) in recent phase 3 trials involving similar Chinese populations (-9.8% and -17.5%, respectively). These findings warrant further investigation into GZR18's potential to offer superior weight management efficacy over multi-target incretin analogs. Disclosure L. Ji: None. W. Chen: None. R. Dong: None. M. Yuan: None. D. Zhao: None. S. Pang: None. L. Zhao: None. J. Zhao: None. Z. Gan: None.
{"title":"1858-LB: A Novel GLP-1 Analog, GZR18, Induced an 18.6% Weight Reduction in Subjects with Obesity in a Phase Ib/IIa Trial","authors":"LINONG JI, WEI CHEN, RUIHUA DONG, MINGXIA YUAN, DONG ZHAO, SHUGUANG PANG, LIYUAN ZHAO, JING ZHAO, ZHONG-RU GAN","doi":"10.2337/db24-1858-lb","DOIUrl":"https://doi.org/10.2337/db24-1858-lb","url":null,"abstract":"It remains unclear whether the superior efficacy of multi-target incretin analogs versus single-target incretins in obesity treatment. This randomized, double-blind, placebo-controlled, dose-escalation phase Ib/IIa study aimed to assess the efficacy and safety of a GLP-1 analog, GZR18, in Chinese adults with obesity. The study investigated the weight loss potential of GZR18 and evaluated the feasibility of administrating GZR18 at different frequencies. Thirty-six participants with obesity were randomized 3:1 to receive 30 mg of GZR18 or a placebo for 35 weeks, including a 31-week dose-escalation period. Upon dose escalation to 9 mg/week, subjects were divided into dosing sub-cohorts of QW or Q2W. Endpoints were body weight change and AEs incidence. The average weight loss of GZR18 adjusted by placebo was 18.6% in QW group and 13.5% in Q2W group, with no IP-related serious AEs. Gastrointestinal AEs were reported most frequently, mainly in early dose-escalation period. GZR18 reduced body weight robustly and improved metabolic profiles in study participants. Its weight-loss effects surpassed those of Semaglutide (2.4 mg) and Tirzepatide (15 mg) in recent phase 3 trials involving similar Chinese populations (-9.8% and -17.5%, respectively). These findings warrant further investigation into GZR18's potential to offer superior weight management efficacy over multi-target incretin analogs. Disclosure L. Ji: None. W. Chen: None. R. Dong: None. M. Yuan: None. D. Zhao: None. S. Pang: None. L. Zhao: None. J. Zhao: None. Z. Gan: None.","PeriodicalId":11376,"journal":{"name":"Diabetes","volume":"27 1","pages":""},"PeriodicalIF":7.7,"publicationDate":"2024-06-21","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141448579","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}
NELSON LIN, YUN SHI, STELLA S. YI, MARY ANN SEVICK, HUILIN LI, JEANNETTE BEASLEY, YULIN JIANG, IRIS H. ONG, YUJIE BAI, XIMIN YANG, LIWEN SU, LU HU
Objective: Despite well-established evidence supporting the efficacy of the Diabetes Prevention Program (DPP), dissemination of the DPP to underserved communities is suboptimal. INCLUDE is an ADA-funded three year study to assess a multi-level mHealth intervention to provide a culturally tailored, language-concordant DPP and address food insecurity among Chinese immigrants. Here, we report feasibility data from Year 1 of the INCLUDE study. Methods: INCLUDE is a randomized clinical trial with Chinese American adults with BMI ≥ 23 at risk for diabetes with a planned sample size of 150 and intervention duration of 3 months. In Year 1, 75 patients were randomized to intervention (n=38) or control (n=37) groups. Intervention participants received 2-3 culturally adapted in-language DPP videos a week for 12 weeks, biweekly calls from trained bilingual (Mandarin Chinese) study staff, and culturally appropriate produce weekly for 10 weeks at a local farm. The primary aim of the study is to evaluate weight loss at 3 and 6 months. This report presents feasibility data for intervention participants. Results: Intervention participants (n=38, median age 48.5 [IQR 37.5-61.3]) were mostly female (84%), born outside the US (97%), and limited English proficient (82%). Participants reported an average video watch rate of 89% (SD 5.0%), a fresh produce pickup rate of 57% (SD 7.7%), a biweekly call completion rate of 81% (SD 15.5%). Overall retention rate was 95% at 3 months. Most (86%) participants agreed or strongly agreed that the program motivated weight loss, and all agreed or strongly agreed that the program increased confidence to prevent diabetes. Conclusion: Initial results demonstrate feasibility of a culturally adapted multi-level DPP intervention for underserved Chinese immigrants. Additional research with a longer duration and larger sample size is warranted to examine intervention effectiveness with adequate power. Disclosure N. Lin: None. Y. Shi: None. M. Sevick: None. H. Li: None. J. Beasley: None. Y. Jiang: None. I.H. Ong: None. Y. Bai: None. X. Yang: None. L. Su: None. L. Hu: None. Funding American Diabetes Association (7-22-ICTSN-08)
{"title":"1827-LB: A Multilevel, mHealth-Based Culturally Tailored Diabetes Prevention Program for Chinese Immigrants—Preliminary Results from the INCLUDE Study","authors":"NELSON LIN, YUN SHI, STELLA S. YI, MARY ANN SEVICK, HUILIN LI, JEANNETTE BEASLEY, YULIN JIANG, IRIS H. ONG, YUJIE BAI, XIMIN YANG, LIWEN SU, LU HU","doi":"10.2337/db24-1827-lb","DOIUrl":"https://doi.org/10.2337/db24-1827-lb","url":null,"abstract":"Objective: Despite well-established evidence supporting the efficacy of the Diabetes Prevention Program (DPP), dissemination of the DPP to underserved communities is suboptimal. INCLUDE is an ADA-funded three year study to assess a multi-level mHealth intervention to provide a culturally tailored, language-concordant DPP and address food insecurity among Chinese immigrants. Here, we report feasibility data from Year 1 of the INCLUDE study. Methods: INCLUDE is a randomized clinical trial with Chinese American adults with BMI ≥ 23 at risk for diabetes with a planned sample size of 150 and intervention duration of 3 months. In Year 1, 75 patients were randomized to intervention (n=38) or control (n=37) groups. Intervention participants received 2-3 culturally adapted in-language DPP videos a week for 12 weeks, biweekly calls from trained bilingual (Mandarin Chinese) study staff, and culturally appropriate produce weekly for 10 weeks at a local farm. The primary aim of the study is to evaluate weight loss at 3 and 6 months. This report presents feasibility data for intervention participants. Results: Intervention participants (n=38, median age 48.5 [IQR 37.5-61.3]) were mostly female (84%), born outside the US (97%), and limited English proficient (82%). Participants reported an average video watch rate of 89% (SD 5.0%), a fresh produce pickup rate of 57% (SD 7.7%), a biweekly call completion rate of 81% (SD 15.5%). Overall retention rate was 95% at 3 months. Most (86%) participants agreed or strongly agreed that the program motivated weight loss, and all agreed or strongly agreed that the program increased confidence to prevent diabetes. Conclusion: Initial results demonstrate feasibility of a culturally adapted multi-level DPP intervention for underserved Chinese immigrants. Additional research with a longer duration and larger sample size is warranted to examine intervention effectiveness with adequate power. Disclosure N. Lin: None. Y. Shi: None. M. Sevick: None. H. Li: None. J. Beasley: None. Y. Jiang: None. I.H. Ong: None. Y. Bai: None. X. Yang: None. L. Su: None. L. Hu: None. Funding American Diabetes Association (7-22-ICTSN-08)","PeriodicalId":11376,"journal":{"name":"Diabetes","volume":"55 1","pages":""},"PeriodicalIF":7.7,"publicationDate":"2024-06-21","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141448451","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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