1904-LB：在 2 型糖尿病患者中使用 Omnipod 5 自动胰岛素给药系统可改善血糖--SECURE-T2D 中枢试验的结果

IF 6.2 1区医学 Q1 ENDOCRINOLOGY & METABOLISM

Diabetes Pub Date : 2024-06-21 DOI:10.2337/db24-1904-lb

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

{"title":"1904-LB：在 2 型糖尿病患者中使用 Omnipod 5 自动胰岛素给药系统可改善血糖--SECURE-T2D 中枢试验的结果","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":null,"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; Medtronic, embecta, Ascensia Diabetes Care. Research Support; Abbott. Advisory Panel; Sanofi. K.M. Dungan: Advisory Panel; Eli Lilly and Company, Dexcom, Inc. Research Support; Dexcom, Inc. Advisory Panel; Elsevier. Research Support; Abbott, ViaCyte, Inc., Sanofi, Omnipod. Advisory Panel; Omnipod. Other Relationship; Up-To-Date. Speaker's Bureau; Med Learning Group, Medscape, Cardiometabolic Health Congress. Consultant; Oppenheimer & Co. Speaker's Bureau; Integritas. M. Kipnes: None. E. Jauch: Research Support; Insulet Corporation. T. Oser: Research Support; Abbott. Advisory Panel; Medscape. Consultant; Dexcom, Inc. Research Support; Insulet Corporation. V.N. Shah: Consultant; Dexcom, Inc., Insulet Corporation. Research Support; Insulet Corporation. Advisory Panel; Novo Nordisk. Research Support; Novo Nordisk. Advisory Panel; Sanofi, Medscape. Consultant; embecta, Tandem Diabetes Care, Inc. B. Horowitz: Speaker's Bureau; Eli Lilly and Company, Novo Nordisk. Consultant; AbbVie Inc. Research Support; Insulet Corporation, Bayer Inc. A.L. Carlson: Research Support; Medtronic, Insulet Corporation, Tandem Diabetes Care, Inc., Eli Lilly and Company, Sanofi. Other Relationship; Novo Nordisk. Advisory Panel; MannKind Corporation. Research Support; Dexcom, Inc. M.L. Warren: Research Support; Novo Nordisk, Insulet Corporation. Speaker's Bureau; Lilly Diabetes. Advisory Panel; Lilly Diabetes. Research Support; AstraZeneca, Bayer Inc. Speaker's Bureau; Bayer Inc. Research Support; AbbVie Inc., Medtronic, Ascendis Pharma A/S, Amolyt. Speaker's Bureau; Ascendis Pharma A/S, Amgen Inc. Research Support; AstraZeneca. Advisory Panel; Hygieia. W. Deeb: None. J.B. Buse: Other Relationship; Novo Nordisk. Consultant; Corcept Therapeutics. Research Support; Corcept Therapeutics, Dexcom, Inc., Insulet Corporation. Consultant; Alkahest, Anji Pharmaceuticals, Aqua Medical, Altimmune Inc., AstraZeneca, Boehringer-Ingelheim, CeQur, Eli Lilly and Company, embecta, GentiBio, Glyscend Inc., Mellitus Health, Metsera, Pendulum Therapeutics, Praetego, LLC, Stability Health, Terns Pharmaceuticals, Insulet Corporation, Vertex Pharmaceuticals Incorporated, vTv Therapeutics. Other Relationship; Medtronic. Stock/Shareholder; Glyscend Inc., Mellitus Health, Pendulum Therapeutics, Praetego, LLC, Stability Health. J.H. Reed: None. J. Berner: None. T. Blevins: Research Support; Arrowhead Pharmaceuticals, Inc., Insulet Corporation. Advisory Panel; Insulet Corporation. Research Support; Tandem Diabetes Care, Inc., Medtronic. Other Relationship; Medtronic. Advisory Panel; MannKind Corporation. Research Support; MannKind Corporation. Speaker's Bureau; AstraZeneca. Research Support; Lilly Diabetes. Speaker's Bureau; Lilly Diabetes. Research Support; Novo Nordisk. Speaker's Bureau; Novo Nordisk. Research Support; Boehringer-Ingelheim. Speaker's Bureau; Boehringer-Ingelheim. Research Support; Dexcom, Inc., Abbott Diagnostics, ViaCyte, Inc., Amgen Inc., Carmot Therapeutics, Inc. Other Relationship; Nanjing AscendRare Pharmaceutical Technology. C. Bajaj: Consultant; Dexcom, Inc., Lilly Diabetes. C. Kollman: Research Support; Tandem Diabetes Care, Inc., Dexcom, Inc., Juvenile Diabetes Research Foundation (JDRF), Insulet Corporation, MannKind Corporation. D. Raghinaru: None. T.T. Ly: Employee; Insulet Corporation. R.W. 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 This study was funded by Insulet Corporation.","PeriodicalId":11376,"journal":{"name":"Diabetes","volume":null,"pages":null},"PeriodicalIF":6.2000,"publicationDate":"2024-06-21","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":"{\"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\":null,\"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; Medtronic, embecta, Ascensia Diabetes Care. Research Support; Abbott. Advisory Panel; Sanofi. K.M. Dungan: Advisory Panel; Eli Lilly and Company, Dexcom, Inc. Research Support; Dexcom, Inc. Advisory Panel; Elsevier. Research Support; Abbott, ViaCyte, Inc., Sanofi, Omnipod. Advisory Panel; Omnipod. Other Relationship; Up-To-Date. Speaker's Bureau; Med Learning Group, Medscape, Cardiometabolic Health Congress. Consultant; Oppenheimer & Co. Speaker's Bureau; Integritas. M. Kipnes: None. E. Jauch: Research Support; Insulet Corporation. T. Oser: Research Support; Abbott. Advisory Panel; Medscape. Consultant; Dexcom, Inc. Research Support; Insulet Corporation. V.N. Shah: Consultant; Dexcom, Inc., Insulet Corporation. Research Support; Insulet Corporation. Advisory Panel; Novo Nordisk. Research Support; Novo Nordisk. Advisory Panel; Sanofi, Medscape. Consultant; embecta, Tandem Diabetes Care, Inc. B. Horowitz: Speaker's Bureau; Eli Lilly and Company, Novo Nordisk. Consultant; AbbVie Inc. Research Support; Insulet Corporation, Bayer Inc. A.L. Carlson: Research Support; Medtronic, Insulet Corporation, Tandem Diabetes Care, Inc., Eli Lilly and Company, Sanofi. Other Relationship; Novo Nordisk. Advisory Panel; MannKind Corporation. Research Support; Dexcom, Inc. M.L. Warren: Research Support; Novo Nordisk, Insulet Corporation. Speaker's Bureau; Lilly Diabetes. Advisory Panel; Lilly Diabetes. Research Support; AstraZeneca, Bayer Inc. Speaker's Bureau; Bayer Inc. Research Support; AbbVie Inc., Medtronic, Ascendis Pharma A/S, Amolyt. Speaker's Bureau; Ascendis Pharma A/S, Amgen Inc. Research Support; AstraZeneca. Advisory Panel; Hygieia. W. Deeb: None. J.B. Buse: Other Relationship; Novo Nordisk. Consultant; Corcept Therapeutics. Research Support; Corcept Therapeutics, Dexcom, Inc., Insulet Corporation. Consultant; Alkahest, Anji Pharmaceuticals, Aqua Medical, Altimmune Inc., AstraZeneca, Boehringer-Ingelheim, CeQur, Eli Lilly and Company, embecta, GentiBio, Glyscend Inc., Mellitus Health, Metsera, Pendulum Therapeutics, Praetego, LLC, Stability Health, Terns Pharmaceuticals, Insulet Corporation, Vertex Pharmaceuticals Incorporated, vTv Therapeutics. Other Relationship; Medtronic. Stock/Shareholder; Glyscend Inc., Mellitus Health, Pendulum Therapeutics, Praetego, LLC, Stability Health. J.H. Reed: None. J. Berner: None. T. Blevins: Research Support; Arrowhead Pharmaceuticals, Inc., Insulet Corporation. Advisory Panel; Insulet Corporation. Research Support; Tandem Diabetes Care, Inc., Medtronic. Other Relationship; Medtronic. Advisory Panel; MannKind Corporation. Research Support; MannKind Corporation. Speaker's Bureau; AstraZeneca. Research Support; Lilly Diabetes. Speaker's Bureau; Lilly Diabetes. Research Support; Novo Nordisk. Speaker's Bureau; Novo Nordisk. Research Support; Boehringer-Ingelheim. Speaker's Bureau; Boehringer-Ingelheim. Research Support; Dexcom, Inc., Abbott Diagnostics, ViaCyte, Inc., Amgen Inc., Carmot Therapeutics, Inc. Other Relationship; Nanjing AscendRare Pharmaceutical Technology. C. Bajaj: Consultant; Dexcom, Inc., Lilly Diabetes. C. Kollman: Research Support; Tandem Diabetes Care, Inc., Dexcom, Inc., Juvenile Diabetes Research Foundation (JDRF), Insulet Corporation, MannKind Corporation. D. Raghinaru: None. T.T. Ly: Employee; Insulet Corporation. R.W. 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 This study was funded by Insulet Corporation.\",\"PeriodicalId\":11376,\"journal\":{\"name\":\"Diabetes\",\"volume\":null,\"pages\":null},\"PeriodicalIF\":6.2000,\"publicationDate\":\"2024-06-21\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Diabetes\",\"FirstCategoryId\":\"3\",\"ListUrlMain\":\"https://doi.org/10.2337/db24-1904-lb\",\"RegionNum\":1,\"RegionCategory\":\"医学\",\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"Q1\",\"JCRName\":\"ENDOCRINOLOGY & METABOLISM\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Diabetes","FirstCategoryId":"3","ListUrlMain":"https://doi.org/10.2337/db24-1904-lb","RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q1","JCRName":"ENDOCRINOLOGY & METABOLISM","Score":null,"Total":0}

引用次数: 0

摘要

背景：在 2 型糖尿病 (T2D) 中使用胰岛素自动给药 (AID) 的经验有限。方法我们开展了一项多中心关键性临床试验，评估 Omnipod 5 AID 系统在美国一大批不同类型的 2 型糖尿病成人患者中的使用情况。年龄在 18-75 岁、使用胰岛素（基础胰岛素、预混胰岛素或纯基础胰岛素）的 T2D 患者参加了试验，他们的筛查 HbA1c 为 12.0%。非胰岛素药物自始至终都在使用。经过 14 天的标准治疗阶段以了解基线血糖管理情况后，参与者开始接受为期 13 周的 AID 治疗。主要终点是 HbA1c 从基线到 13 周的变化。研究于 2024 年 3 月 1 日结束。研究结果共有 305 名患有 T2D 的成人（平均年龄为 57±11 岁，24% 为黑人，22% 为西班牙裔/拉丁裔）参加了研究并开始了 AID。使用基础胰岛素给药的比例为 79%，仅使用基础胰岛素的比例为 21%，使用 GLP-1 受体类似物的比例为 55%，使用 SGLT1 或 2 抑制剂的比例为 44%。使用 Omnipod 5 13 周后，HbA1c 从基线时的 8.2±1.3% 降至研究结束时的 7.4±0.9%（治疗效果= -0.8%，95% CI：-1.0 至 -0.7，p&lt;0.001）。基线 HbA1c 最高者从 AID 中获益最大（图）。结论这些关键性试验结果表明，Omnipod 5 AID 系统在大量不同的成人 T2D 患者中具有显著疗效。临床试验注册：NCT05815342 披露 F.J. Pasquel：研究支持；Tandem Diabetes Care, Inc.、Insulet Corporation、Dexcom, Inc.、Ideal Medical Technologies、Novo Nordisk。顾问；Dexcom 公司、Medscape。G. Davis：研究支持；Insulet 公司。顾问；Medscape。A.L. Peters：顾问团；礼来糖尿病、Vertex Pharmaceuticals Incorporated、Medscape。研究支持；雅培公司、Insulet 公司。J.C. Parker：诺和诺德、Corcept Therapeutics、Insulet Corporation。L.M. Laffel：顾问；Dexcom, Inc.顾问团；Medscape、Medtronic、Vertex Pharmaceuticals Incorporated。顾问；诺和诺德公司。顾问团；礼来糖尿病公司、Provention Bio 公司、赛诺菲-安万特美国公司、杨森制药公司、MannKind 公司。J. Mathew：无。K.N. Castorino：研究支持；雅培、Dexcom, Inc.Speaker's Bureau; Dexcom, Inc.研究支持；礼来糖尿病公司、美敦力公司、MannKind 公司、Insulet 公司。顾问；Medscape。D.F. Kruger：顾问团；雅培。研究支持；Beta Bionics, Inc.、Carmot Therapeutics, Inc.演讲团；Dexcom，Inc.顾问团；Dexcom, Inc.演讲事务处；礼来糖尿病公司。顾问团；Insulet Corporation。研究支持；Insulet Corporation。顾问团；MannKind 公司、诺和诺德公司。发言人办公室；诺和诺德公司。研究支持；诺和诺德公司。顾问团；Provention Bio, Inc.赛诺菲、Xeris Pharmaceuticals, Inc.顾问团；Pendulum Therapeutics。研究支持；Tandem Diabetes Care, Inc.顾问团；Cequr.Speaker's Bureau; Cequr.顾问团；Medtronic、embecta、Ascensia Diabetes Care。研究支持；雅培。顾问团；赛诺菲K.M. Dungan：顾问小组；礼来公司、Dexcom, Inc.研究支持；Dexcom, Inc.顾问团；爱思唯尔。研究支持；雅培、ViaCyte, Inc.、赛诺菲、Omnipod。顾问团；Omnipod.其他关系；Up-To-Date。发言人；Med Learning Group、Medscape、心脏代谢健康大会。顾问；Oppenheimer & Co.演讲事务处；Integritas。M. Kipnes：无。E. Jauch：研究支持；Insulet 公司。T. Oser：研究支持；雅培。顾问团；Medscape。顾问；Dexcom, Inc.研究支持；Insulet Corporation。V.N. Shah：顾问；Dexcom 公司、Insulet 公司。研究支持；Insulet Corporation。顾问团；诺和诺德公司。研究支持；诺和诺德公司。顾问团；赛诺菲、Medscape。顾问；embecta、Tandem Diabetes Care, Inc.B. Horowitz：Speaker's Bureau; Eli Lilly and Company, Novo Nordisk.顾问；艾伯维公司（AbbVie Inc.研究支持；Insulet 公司、拜耳公司。A.L. Carlson：研究支持；美敦力、Insulet Corporation、Tandem Diabetes Care, Inc.、礼来公司、赛诺菲。其他关系；诺和诺德公司。顾问团；MannKind 公司。研究支持；Dexcom 公司。M.L. Warren：研究支持；诺和诺德公司、Insulet 公司。Speaker's Bureau; Lilly Diabetes.顾问团；礼来糖尿病。研究支持；阿斯利康、拜耳公司。Speaker's Bureau; Bayer Inc.研究支持；AbbVie Inc.、Medtronic、Ascendis Pharma A/S、Amolyt。Speaker's Bureau; Ascendis Pharma A/S, Amgen Inc.研究支持；阿斯利康。顾问团；Hygieia。W. Deeb：无。J.B. Buse：其他关系；诺和诺德公司。顾问；Corcept Therapeutics。研究支持；Corcept Therapeutics、Dexcom、Insulet Corporation。顾问；Alkahest、Anji Pharmaceuticals、Aqua Medical、Altimmune Inc.、AstraZeneca、Boehringer-Ingelheim、CeQur、Eli Lilly and Company、embecta、GentiBio、Glyscend Inc.

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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

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; Medtronic, embecta, Ascensia Diabetes Care. Research Support; Abbott. Advisory Panel; Sanofi. K.M. Dungan: Advisory Panel; Eli Lilly and Company, Dexcom, Inc. Research Support; Dexcom, Inc. Advisory Panel; Elsevier. Research Support; Abbott, ViaCyte, Inc., Sanofi, Omnipod. Advisory Panel; Omnipod. Other Relationship; Up-To-Date. Speaker's Bureau; Med Learning Group, Medscape, Cardiometabolic Health Congress. Consultant; Oppenheimer & Co. Speaker's Bureau; Integritas. M. Kipnes: None. E. Jauch: Research Support; Insulet Corporation. T. Oser: Research Support; Abbott. Advisory Panel; Medscape. Consultant; Dexcom, Inc. Research Support; Insulet Corporation. V.N. Shah: Consultant; Dexcom, Inc., Insulet Corporation. Research Support; Insulet Corporation. Advisory Panel; Novo Nordisk. Research Support; Novo Nordisk. Advisory Panel; Sanofi, Medscape. Consultant; embecta, Tandem Diabetes Care, Inc. B. Horowitz: Speaker's Bureau; Eli Lilly and Company, Novo Nordisk. Consultant; AbbVie Inc. Research Support; Insulet Corporation, Bayer Inc. A.L. Carlson: Research Support; Medtronic, Insulet Corporation, Tandem Diabetes Care, Inc., Eli Lilly and Company, Sanofi. Other Relationship; Novo Nordisk. Advisory Panel; MannKind Corporation. Research Support; Dexcom, Inc. M.L. Warren: Research Support; Novo Nordisk, Insulet Corporation. Speaker's Bureau; Lilly Diabetes. Advisory Panel; Lilly Diabetes. Research Support; AstraZeneca, Bayer Inc. Speaker's Bureau; Bayer Inc. Research Support; AbbVie Inc., Medtronic, Ascendis Pharma A/S, Amolyt. Speaker's Bureau; Ascendis Pharma A/S, Amgen Inc. Research Support; AstraZeneca. Advisory Panel; Hygieia. W. Deeb: None. J.B. Buse: Other Relationship; Novo Nordisk. Consultant; Corcept Therapeutics. Research Support; Corcept Therapeutics, Dexcom, Inc., Insulet Corporation. Consultant; Alkahest, Anji Pharmaceuticals, Aqua Medical, Altimmune Inc., AstraZeneca, Boehringer-Ingelheim, CeQur, Eli Lilly and Company, embecta, GentiBio, Glyscend Inc., Mellitus Health, Metsera, Pendulum Therapeutics, Praetego, LLC, Stability Health, Terns Pharmaceuticals, Insulet Corporation, Vertex Pharmaceuticals Incorporated, vTv Therapeutics. Other Relationship; Medtronic. Stock/Shareholder; Glyscend Inc., Mellitus Health, Pendulum Therapeutics, Praetego, LLC, Stability Health. J.H. Reed: None. J. Berner: None. T. Blevins: Research Support; Arrowhead Pharmaceuticals, Inc., Insulet Corporation. Advisory Panel; Insulet Corporation. Research Support; Tandem Diabetes Care, Inc., Medtronic. Other Relationship; Medtronic. Advisory Panel; MannKind Corporation. Research Support; MannKind Corporation. Speaker's Bureau; AstraZeneca. Research Support; Lilly Diabetes. Speaker's Bureau; Lilly Diabetes. Research Support; Novo Nordisk. Speaker's Bureau; Novo Nordisk. Research Support; Boehringer-Ingelheim. Speaker's Bureau; Boehringer-Ingelheim. Research Support; Dexcom, Inc., Abbott Diagnostics, ViaCyte, Inc., Amgen Inc., Carmot Therapeutics, Inc. Other Relationship; Nanjing AscendRare Pharmaceutical Technology. C. Bajaj: Consultant; Dexcom, Inc., Lilly Diabetes. C. Kollman: Research Support; Tandem Diabetes Care, Inc., Dexcom, Inc., Juvenile Diabetes Research Foundation (JDRF), Insulet Corporation, MannKind Corporation. D. Raghinaru: None. T.T. Ly: Employee; Insulet Corporation. R.W. 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 This study was funded by Insulet Corporation.

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来源期刊

Diabetes 医学-内分泌学与代谢

CiteScore

12.50

自引率

2.60%

发文量

1968

审稿时长

1 months

期刊介绍： Diabetes is a scientific journal that publishes original research exploring the physiological and pathophysiological aspects of diabetes mellitus. We encourage submissions of manuscripts pertaining to laboratory, animal, or human research, covering a wide range of topics. Our primary focus is on investigative reports investigating various aspects such as the development and progression of diabetes, along with its associated complications. We also welcome studies delving into normal and pathological pancreatic islet function and intermediary metabolism, as well as exploring the mechanisms of drug and hormone action from a pharmacological perspective. Additionally, we encourage submissions that delve into the biochemical and molecular aspects of both normal and abnormal biological processes. However, it is important to note that we do not publish studies relating to diabetes education or the application of accepted therapeutic and diagnostic approaches to patients with diabetes mellitus. Our aim is to provide a platform for research that contributes to advancing our understanding of the underlying mechanisms and processes of diabetes.