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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 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 7.7 1区 医学 Q1 Medicine 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
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
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<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.
{"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 <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","PeriodicalId":11376,"journal":{"name":"Diabetes","volume":null,"pages":null},"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}
引用次数: 0
1162-P: Global Burden Attributable to High Body Mass Index in Young Adults from 1990 to 2019, with Projections to 2050 1162-P:1990 年至 2019 年全球青壮年体重指数偏高造成的负担,以及到 2050 年的预测值
IF 7.7 1区 医学 Q1 Medicine Pub Date : 2024-06-21 DOI: 10.2337/db24-1162-p
JINGXUAN WANG, YUE HUANG, VICTOR W. ZHONG
Introduction: The global health impacts of escalating obesity burden on young adults remain insufficiently understood. We conducted a comprehensive evaluation of the disease burden attributable to high body mass index (BMI) in young adults from 1990 to 2050. Methods: Based on the Global Burden of Disease Study 2019, we analyzed deaths and disability-adjusted life years (DALYs) attributable to high BMI in young adults aged 20-44 years globally and by age, sex, year, location, and disease, between 1990 and 2019. Future projections until 2050 were further assessed. Results: The global burden due to high BMI in young adults more than doubled during 1990-2019, reaching 24,510 (20,192-28,966) thousand DALYs and 322 (258-384) thousand deaths in 2019. Males had higher burden and faster increase than females. In 2019, middle Socio-demographic Index (SDI) regions had the highest age-standardized rates of deaths and DALYs, while low-middle SDI regions witnessed the largest rise. Significant variations across different countries were observed (Figure 1). Nearly 25% of the DALYs were attributed to diabetes and kidney diseases, which showed the fastest increase. By 2050, the age-standardized DALY rate attributable to high BMI tripled that in 1990. Conclusion: Targeted weight management interventions in young adults are urgently needed to fight against the soaring disease burden caused by high BMI. Disclosure J. Wang: None. Y. Huang: None. V.W. Zhong: None.
导言:人们对肥胖负担不断加重给全球青壮年健康造成的影响仍缺乏足够的了解。我们对 1990 年至 2050 年期间青壮年高体重指数(BMI)导致的疾病负担进行了全面评估。方法:基于《2019 年全球疾病负担研究》,我们分析了 1990 年至 2019 年期间全球 20-44 岁青壮年因高体重指数导致的死亡和残疾调整生命年数(DALYs),并按年龄、性别、年份、地点和疾病进行了分类。对 2050 年之前的未来预测进行了进一步评估。结果:1990-2019 年间,青壮年体重指数高所造成的全球负担增加了一倍多,到 2019 年将达到 24,510 (20,192-28,966) 千 DALYs 和 322 (258-384) 千例死亡。与女性相比,男性的负担更重,增长速度更快。2019年,社会人口指数(SDI)中等地区的年龄标准化死亡率和残疾调整寿命年数最高,而社会人口指数(SDI)中等偏低地区的上升幅度最大。不同国家之间存在显著差异(图 1)。近 25% 的残疾调整寿命年数归因于糖尿病和肾脏疾病,这两种疾病的增长速度最快。到 2050 年,高体重指数导致的年龄标准化残疾调整寿命年数是 1990 年的三倍。结论迫切需要对青壮年进行有针对性的体重管理干预,以应对高体重指数导致的疾病负担飙升。披露 J. Wang:无。Y. Huang: None.V.W. Zhong:无。
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引用次数: 0
983-P: Long-Term Improvement in CGM-Measured Glycemic Control in Adults with Type 2 Diabetes Not Treated with Insulin—Real-World Data 983-P: CGM 测量的未使用胰岛素治疗的 2 型糖尿病成人血糖控制的长期改善--真实世界数据
IF 7.7 1区 医学 Q1 Medicine Pub Date : 2024-06-21 DOI: 10.2337/db24-983-p
JENNIFER E. LAYNE, LAUREN H. JEPSON, ALEXANDER CARITE, RICHARD M. BERGENSTAL
Objectives: Emerging evidence indicates that CGM use is associated with improvements in glycemic control in adults with noninsulin treated T2D. This real-world study evaluated CGM metrics for one year after CGM initiation in this population. Methods: Data were analyzed from Dexcom G6 and G7 users who self-reported: T2D, ≥18 yr, gender, no insulin use and had baseline TIR ≤70%. Outcomes were change in CGM metrics from baseline to 6 months and 1 year, and proportion with TIR >70% at follow-up overall and for younger (<65 yr) and older (≥65 yr) cohorts. Results: CGM users (n=3,840) were: mean (SD): 52.5 (11.2) yr, 48% female, TIR 70-180 mg/dL 41.7% (21.4) and 12.4% of participants were ≥65 yr. Significant improvement was observed at 6 months with continued improvement at 1 year (Table) for all CGM metrics not at target values at baseline. The proportion of CGM users meeting TIR >70% increased from 0% to 37.9% at 6 months and to 43.1% at 1 year. CGM was worn 84.7% of days. Outcomes were very similar for younger and older adults. One exception of note was the change in the TITR 70-140 mg/dL at 1 year, <65 yr: +17.1% and ≥65 yr: +12.7%, but the <65 yr group started with a lower baseline TITR. Conclusion: In this large, real-world study of adults with suboptimally controlled T2D not using insulin, CGM use was associated with meaningful improvements in glycemic control at 6 months with ongoing improvement at 1 year. Disclosure J.E. Layne: Employee; Dexcom, Inc. Stock/Shareholder; Dexcom, Inc. Employee; Verily Life Sciences. L.H. Jepson: Employee; Dexcom, Inc. Stock/Shareholder; Dexcom, Inc. A. Carite: Employee; Dexcom, Inc. Stock/Shareholder; Dexcom, Inc. 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.
目的:新的证据表明,CGM 的使用与非胰岛素治疗的成人 T2D 患者血糖控制的改善有关。这项真实世界研究评估了该人群使用 CGM 一年后的 CGM 指标。方法:对 Dexcom G6 和 G7 用户的数据进行了分析,这些用户自我报告:T2D、≥18 岁、性别、未使用胰岛素且基线 TIR ≤70%。结果是 CGM 指标从基线到 6 个月和 1 年的变化,以及总体和年轻组(<65 岁)和年长组(≥65 岁)随访时 TIR >70% 的比例。结果CGM 用户(n=3,840)的平均年龄(SD):52.5(11.2)岁,48% 为女性,TIR 70-180 mg/dL 41.7% (21.4),12.4% 年龄≥65 岁。达到 TIR >70% 的 CGM 用户比例从 0% 增加到 6 个月时的 37.9%,1 年时增加到 43.1%。佩戴 CGM 的天数占 84.7%。年轻人和老年人的结果非常相似。值得注意的一个例外是 1 年时 TITR 70-140 mg/dL 的变化,<65 岁:+17.1%,≥65 岁:+12.7%:+12.7%,但<65 岁组开始时的基线 TITR 较低。结论在这项针对未使用胰岛素、血糖控制不理想的 T2D 成人的大型真实世界研究中,CGM 的使用与 6 个月血糖控制的显著改善相关,并且在 1 年后仍有持续改善。信息披露 J.E. Layne:员工;Dexcom,Inc.股票/股东;Dexcom, Inc.员工;Verily 生命科学公司。L.H. Jepson:员工;Dexcom, Inc.股票/股东; Dexcom, Inc.A. Carite:员工;Dexcom, Inc.股票/股东; Dexcom, Inc.R.M. Bergenstal:其他关系;雅培。研究支持; Arkray Marketing.顾问;Ascensia Diabetes Care、Bigfoot Biomedical, Inc.、CeQur.其他关系;Dexcom 公司、礼来公司。顾问;embecta、Hygieia。研究支持;Insulet 公司。顾问;MannKind 公司。其他关系;美敦力、诺和诺德。顾问;Onduo LLC、罗氏糖尿病护理公司。其他关系;赛诺菲。研究支持;Tandem Diabetes Care, Inc.其他关系;联合健康集团。顾问;Vertex Pharmaceuticals Incorporated、Zealand Pharma A/S。
{"title":"983-P: Long-Term Improvement in CGM-Measured Glycemic Control in Adults with Type 2 Diabetes Not Treated with Insulin—Real-World Data","authors":"JENNIFER E. LAYNE, LAUREN H. JEPSON, ALEXANDER CARITE, RICHARD M. BERGENSTAL","doi":"10.2337/db24-983-p","DOIUrl":"https://doi.org/10.2337/db24-983-p","url":null,"abstract":"Objectives: Emerging evidence indicates that CGM use is associated with improvements in glycemic control in adults with noninsulin treated T2D. This real-world study evaluated CGM metrics for one year after CGM initiation in this population. Methods: Data were analyzed from Dexcom G6 and G7 users who self-reported: T2D, ≥18 yr, gender, no insulin use and had baseline TIR ≤70%. Outcomes were change in CGM metrics from baseline to 6 months and 1 year, and proportion with TIR >70% at follow-up overall and for younger (<65 yr) and older (≥65 yr) cohorts. Results: CGM users (n=3,840) were: mean (SD): 52.5 (11.2) yr, 48% female, TIR 70-180 mg/dL 41.7% (21.4) and 12.4% of participants were ≥65 yr. Significant improvement was observed at 6 months with continued improvement at 1 year (Table) for all CGM metrics not at target values at baseline. The proportion of CGM users meeting TIR >70% increased from 0% to 37.9% at 6 months and to 43.1% at 1 year. CGM was worn 84.7% of days. Outcomes were very similar for younger and older adults. One exception of note was the change in the TITR 70-140 mg/dL at 1 year, <65 yr: +17.1% and ≥65 yr: +12.7%, but the <65 yr group started with a lower baseline TITR. Conclusion: In this large, real-world study of adults with suboptimally controlled T2D not using insulin, CGM use was associated with meaningful improvements in glycemic control at 6 months with ongoing improvement at 1 year. Disclosure J.E. Layne: Employee; Dexcom, Inc. Stock/Shareholder; Dexcom, Inc. Employee; Verily Life Sciences. L.H. Jepson: Employee; Dexcom, Inc. Stock/Shareholder; Dexcom, Inc. A. Carite: Employee; Dexcom, Inc. Stock/Shareholder; Dexcom, Inc. 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.","PeriodicalId":11376,"journal":{"name":"Diabetes","volume":null,"pages":null},"PeriodicalIF":7.7,"publicationDate":"2024-06-21","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141448655","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
1936-LB: The Challenge of Obtaining Diabetes Technology Supplies in Adults with Type 1 Diabetes 1936-LB: 1 型糖尿病成人患者获取糖尿病技术用品的挑战
IF 7.7 1区 医学 Q1 Medicine Pub Date : 2024-06-21 DOI: 10.2337/db24-1936-lb
ANDREW A. WELCH, THOMAS KNOERL, ELIZABETH J. KOPRAS, SARAH CORATHERS, MERCEDES FALCIGLIA
Background: Individuals with Type 1 Diabetes (T1D) face barriers to reliably obtain prescribed technology supplies (continuous glucose monitors [CGM]/insulin pump supplies). The frequency of annual supply access interruptions (ASAI) and the associated burden (emotional, financial, time) with this process are unclear. Objective: To quantify ASAI of technology supplies/insulin and associated burden in adults with T1D. Methods: A 64-question online survey was distributed to the T1D Exchange registry for US adults with T1D. ASAI was defined as total instances that individuals ran out of CGM, insulin pump supplies, and/or insulin in the past year. The burden to obtain supplies was assessed by a 1-10 scale (10 = strongly agree). Means and SD were reported. Significance of comparisons was assessed with t-tests or ANOVA for parametric data, and Mann-Whitney or Kruskal-Wallis tests for non-parametric data (significant = p<0.05). Results: Responses were completed by 2151 surveyed. Mean age was 49 years, 73% female, average A1C 6.7%, with 96% and 80% utilizing CGM and insulin pumps respectively. ASAI averaged 1.8 and varied significantly based on gender (Female = 1.9), insurance (Medicaid = 3.9), income (None = 3.23), race (Black = 3.0), and location (Rural = 2.3). Emotional burden (worry about running out of supplies) was significantly higher in women, those without insurance, lower annual income, and non-white race. A 10 was reported for “It is difficult to afford supplies” by 13% and “I spend too much time obtaining supplies” by 11%. Early CGM and insulin pump cannula failures were reported by 45% and 48% of respondents respectively. The top reason for ASAI was “Required prior authorization” in 36% of respondents. The top strategies to avoid ASAI were “Call supply company to request extra supplies” (25.9%), and “Use supply for longer than recommended” (25.5%). Conclusion: Challenges in obtaining diabetes supplies are significant and disproportionately affect certain socioeconomic groups with T1D. Disclosure A.A. Welch: None. T. Knoerl: None. E.J. Kopras: None. S. Corathers: None. M. Falciglia: None.
背景:1 型糖尿病(T1D)患者在可靠获取处方技术用品(连续血糖监测仪 [CGM] / 胰岛素泵用品)方面面临障碍。目前尚不清楚每年供应中断 (ASAI) 的频率以及与此相关的负担(情感、经济、时间)。目标:量化 T1D 成人患者技术用品/胰岛素的 ASAI 和相关负担。方法:进行一项包含 64 个问题的在线调查:向美国成人 T1D 患者 T1D Exchange 登记处发放了一份包含 64 个问题的在线调查问卷。ASAI的定义是过去一年中个人用完CGM、胰岛素泵用品和/或胰岛素的总次数。获得供应品的负担按 1-10 级进行评估(10 = 非常同意)。报告均值和标度。参数数据采用 t 检验或方差分析,非参数数据采用 Mann-Whitney 检验或 Kruskal-Wallis 检验(显著 = p<0.05)。结果:2151 名受访者填写了问卷。平均年龄为 49 岁,73% 为女性,平均 A1C 为 6.7%,96% 和 80% 分别使用 CGM 和胰岛素泵。ASAI平均为1.8,并因性别(女性=1.9)、保险(医疗补助=3.9)、收入(无=3.23)、种族(黑人=3.0)和地区(农村=2.3)而有显著差异。女性、无保险、年收入较低和非白人种族的情绪负担(担心物资耗尽)明显较高。13%的受访者表示 "很难负担得起耗材",11%的受访者表示 "我在获取耗材上花费了太多的时间"。分别有 45% 和 48% 的受访者报告了 CGM 和胰岛素泵插管的早期故障。36% 的受访者表示,ASAI 的首要原因是 "需要事先授权"。避免 ASAI 的首要策略是 "致电供应公司要求额外供应"(25.9%)和 "使用供应时间超过建议时间"(25.5%)。结论:获取糖尿病用品方面的挑战是巨大的,对某些患有 T1D 的社会经济群体的影响尤为严重。披露 A.A. Welch:无。T. Knoerl:无。E.J. Kopras: 无:无。S. Corathers:无。M. Falciglia:无。
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引用次数: 0
56-OR: Impact of Delays in Statin Therapy Due to Statin Nonacceptance on Cardiovascular Outcomes in Patients with Diabetes 56-OR: 因不接受他汀类药物而延迟他汀类药物治疗对糖尿病患者心血管结果的影响
IF 7.7 1区 医学 Q1 Medicine Pub Date : 2024-06-21 DOI: 10.2337/db24-56-or
NISARG SHAH, ZHOU LAN, SETH S. MARTIN, C J. BROWN, ALEXANDER TURCHIN
Introduction: Many patients with diabetes do not accept their clinicians’ statin therapy recommendations. Long-term clinical sequalae of statin non-acceptance are unknown. Methods: We conducted a retrospective cohort study of patients with diabetes without ASCVD treated at Mass General Brigham in 2000-2018. We analyzed the relationship between delay in statin therapy due to statin non-acceptance by patients and the incidence of CV events (MI or ischemic stroke). Information about statin non-acceptance and baseline characteristics was obtained from the electronic medical records and a previously validated Natural Language Processing tool. Results: The mean age of 7,239 study patients was 55.0 (SD 11.9) years; 3,769 (52.1%) were female. Their mean baseline LDL-C was 138 (SD 28) mg/dl and the mean HbA1c was 7.5% (SD 1.9). A total of 1,280 (17.7%) of patients delayed statin therapy (by a mean of 2.7 (SD 3.1) years during which they had a mean of 4.6 (SD 9.1) provider visits) due to initial non-acceptance. These patients then continued on statin therapy for a mean of 7.1 (SD 4.8) years. Over the mean follow-up time of 8.2 (SD 4.6) years, 455 (6.3%) of patients had a CV event. Accounting for all-cause death as a competing risk, 6.4% (95% CI 5.6-7.2) of patients who accepted vs. 8.5% (95% CI 6.8-10.5) of patients who initially declined statin therapy recommendation experienced a CV event at 10 years (p = 0.001). In a multivariable Cox analysis that adjusted for patients’ demographic characteristics and comorbidities and clustering within providers, initial non-acceptance of statin therapy was associated with increased risk of a CV event (HR 1.49, 95% CI 1.16-1.91, p = 0.002). Conclusions: Our study shows that patients with diabetes without ASCVD who delay statin therapy due to statin non-acceptance have an increased risk of CV events. This finding identifies a previously unexplored gap in care that increases cardiovascular burden in this already high-risk population. Disclosure N. Shah: None. Z. Lan: None. S.S. Martin: Consultant; Amgen Inc., AstraZeneca, Bristol-Myers Squibb Company, Chroma, Kaneka Inc., NewAmsterdam, Novartis AG, Novo Nordisk, Premier, Sanofi. C.J. Brown: None. A. Turchin: Research Support; Eli Lilly and Company, Novo Nordisk. Consultant; Novo Nordisk, Proteomics International. Research Support; AstraZeneca. Funding PCORI (ME-2019C1-15328)
引言许多糖尿病患者不接受临床医生提出的他汀类药物治疗建议。不接受他汀类药物治疗的长期临床后果尚不清楚。研究方法我们对 2000-2018 年在麻省总医院布里格姆分院接受治疗的无 ASCVD 的糖尿病患者进行了一项回顾性队列研究。我们分析了因患者不接受他汀类药物而导致的他汀类药物治疗延迟与心血管事件(心肌梗死或缺血性卒中)发生率之间的关系。有关他汀类药物不被接受和基线特征的信息来自电子病历和之前验证过的自然语言处理工具。研究结果7,239 名研究患者的平均年龄为 55.0 岁(SD 11.9),其中 3,769 人(52.1%)为女性。他们的平均基线 LDL-C 为 138 (SD 28) mg/dl,平均 HbA1c 为 7.5% (SD 1.9)。共有 1,280 名患者(17.7%)因最初不接受他汀类药物治疗而推迟了治疗(平均推迟了 2.7 年(标准差 3.1 年),在此期间,他们平均接受了 4.6 次(标准差 9.1 次)医疗服务。这些患者继续接受他汀类药物治疗的平均时间为 7.1 年(标准差 4.8 年)。在平均 8.2 (SD 4.6) 年的随访时间内,455 例(6.3%)患者发生了冠心病事件。考虑到全因死亡这一竞争风险,接受他汀治疗建议的患者中有 6.4% (95% CI 5.6-7.2)在 10 年内发生过 CV 事件,而最初拒绝他汀治疗建议的患者中有 8.5%(95% CI 6.8-10.5)在 10 年内发生过 CV 事件(P = 0.001)。在对患者的人口统计学特征、合并症和医疗机构内的聚类进行调整的多变量 Cox 分析中,最初不接受他汀类药物治疗的患者发生 CV 事件的风险增加(HR 1.49,95% CI 1.16-1.91,p = 0.002)。结论我们的研究表明,因不接受他汀类药物而延迟他汀类药物治疗的无 ASCVD 的糖尿病患者发生 CV 事件的风险会增加。这一发现发现了一个以前未被发现的护理漏洞,它增加了这一高危人群的心血管负担。披露 N. Shah:无。Z. Lan:无。S.S. Martin:无:顾问;安进公司、阿斯利康、百时美施贵宝公司、Chroma、Kaneka Inc.、NewAmsterdam、诺华股份公司、诺和诺德、Premier、赛诺菲。C.J. 布朗:无。A. Turchin:研究支持;礼来公司、诺和诺德公司。顾问;诺和诺德、国际蛋白质组学协会。研究支持;阿斯利康。资助 PCORI (ME-2019C1-15328)
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引用次数: 0
1981-LB: Modeling the Impact of Semaglutide 2.4 mg in U.S. Patients with Atherosclerotic Cardiovascular Disease and BMI ≥27 kg/m2 1981-LB:模拟塞马鲁肽 2.4 mg 对患有动脉粥样硬化性心血管疾病且体重指数≥27 kg/m2 的美国患者的影响
IF 7.7 1区 医学 Q1 Medicine Pub Date : 2024-06-21 DOI: 10.2337/db24-1981-lb
MADS FAURBY, MICHAEL G. NANNA, JOSHUA C. TOLIVER, QUAN V. DOAN, ALASDAIR D. HENRY, THOMAS SCASSELLATI SFORZOLINI, ALINA LEVINE, ANTHONY FABRICATORE, AZADEH S. HOUSHMAND-OEREGAARD, ANN MARIE NAVAR
The SELECT trial demonstrated a 20% risk reduction in major adverse cardiovascular events (MACE) with semaglutide 2.4 mg in adults with atherosclerotic cardiovascular disease (ASCVD) and overweight/obesity (BMI ≥27 kg/m2). We aimed to quantify the potential population impact of this treatment in the US. National Health and Examination Survey (NHANES) data were used to characterize the US population meeting SELECT trial criteria: BMI ≥27 kg/m2, age ≥45 years, ASCVD, and no diabetes, with the number of potential treatment candidates determined using 2023 census projections. The 10-year rate of recurrent MACE events was estimated based on the SMART2 risk calculator. The potential treatment effect of semaglutide 2.4 mg on the number of MACE events in this population was estimated using results from the SELECT trial. As of 2023, 6,161,981 US adults met SELECT inclusion criteria (mean age 67.2 ± 9.9 years, 43.6% female, mean BMI 32.6 ± 5.0 kg/m2). Based on SMART2, an estimated 2,529,310 individuals (41.0%) will experience at least one MACE event in the next 10 years, with the total number of events estimated at 3,064,993. Of these, 497,631 MACE events could be avoided with semaglutide 2.4 mg treatment (Table). The possible therapeutic impact of semaglutide 2.4 mg on eligible US adults is substantial, with the potential to prevent nearly half a million CV events and deaths over the next 10 years. Disclosure M. Faurby: Employee; Novo Nordisk. M.G. Nanna: Consultant; Merck & Co., Inc., HeartFlow, Inc. J.C. Toliver: Employee; Novo Nordisk. Q.V. Doan: Consultant; Novo Nordisk, Daiichi Sankyo, Akebia Therapeutics, Inc., AbbVie Inc. A.D. Henry: Consultant; Novo Nordisk. T. Scassellati Sforzolini: Consultant; Novo Nordisk. A. Levine: Consultant; Novo Nordisk. A. Fabricatore: Employee; Novo Nordisk. Stock/Shareholder; Novo Nordisk. A.S. Houshmand-Oeregaard: Employee; Novo Nordisk. Stock/Shareholder; Eli Lilly and Company, Novo Nordisk A/S. A. Navar: Consultant; ESPERION Therapeutics, Inc. Research Support; ESPERION Therapeutics, Inc. Consultant; Amgen Inc. Research Support; Amgen Inc., Bristol-Myers Squibb Company. Consultant; Bristol-Myers Squibb Company, Janssen Pharmaceuticals, Inc., Merck & Co., Inc., Bayer Inc., Novartis Pharmaceuticals Corporation, Novo Nordisk, Pfizer Inc., New Amsterdam, Boehringer-Ingelheim, Eli Lilly and Company, Silence Therapeutics. Funding Novo Nordisk, Inc.
SELECT 试验表明,对于患有动脉粥样硬化性心血管疾病(ASCVD)和超重/肥胖(体重指数≥27 kg/m2)的成年人,使用 2.4 mg semaglutide 可将主要不良心血管事件(MACE)的风险降低 20%。我们的目标是量化这种治疗方法对美国人口的潜在影响。美国国家健康与检查调查(NHANES)数据用于描述符合 SELECT 试验标准的美国人口特征:BMI≥27 kg/m2、年龄≥45岁、ASCVD、无糖尿病,并根据2023年的人口普查预测确定了潜在的候选治疗人数。根据 SMART2 风险计算器估算了 10 年的复发性 MACE 事件发生率。根据 SELECT 试验的结果,估算出 semaglutide 2.4 mg 对该人群中 MACE 事件数量的潜在治疗效果。截至 2023 年,共有 6161981 名美国成年人符合 SELECT 纳入标准(平均年龄为 67.2 ± 9.9 岁,43.6% 为女性,平均体重指数为 32.6 ± 5.0 kg/m2)。根据SMART2,估计有2,529,310人(41.0%)将在未来10年内经历至少一次MACE事件,事件总数估计为3,064,993起。其中,497,631 例 MACE 事件可通过使用 2.4 mg semaglutide 治疗而避免(表)。在未来 10 年内,塞马鲁肽 2.4 毫克对符合条件的美国成年人可能产生的治疗影响是巨大的,有可能避免近 50 万例心血管事件和死亡。披露 M. Faurby:诺和诺德公司雇员。M.G. Nanna:默克公司、HeartFlow公司顾问。J.C. Toliver:诺和诺德公司员工:诺和诺德公司员工。Q.V. Doan:顾问;诺和诺德公司、第一三共公司、Akebia Therapeutics 公司、艾伯维公司。A.D. Henry:诺和诺德公司顾问T. Scassellati Sforzolini:诺和诺德公司顾问A. Levine:诺和诺德公司顾问A. Fabricatore:员工; 诺和诺德诺和诺德公司股票/股东。A.S. Houshmand-Oeregaard:诺和诺德员工。股票/股东;礼来公司、诺和诺德公司。A. Navar:顾问;ESPERION Therapeutics, Inc.研究支持;ESPERION Therapeutics, Inc.顾问;Amgen Inc.研究支持;安进公司、百时美施贵宝公司。顾问;百时美施贵宝公司、杨森制药公司、默克公司、拜耳公司、诺华制药公司、诺和诺德公司、辉瑞公司、新阿姆斯特丹公司、勃林格殷格翰公司、礼来公司、Silence Therapeutics。资助诺和诺德公司
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引用次数: 0
17-OR: ADA Presidents' Select Abstract: Oral Bisphenol A Administration Decreased Peripheral Insulin Sensitivity in Healthy Adults 17-OR:ADA 主席精选摘要:口服双酚 A 会降低健康成人的外周胰岛素敏感性
IF 7.7 1区 医学 Q1 Medicine Pub Date : 2024-06-21 DOI: 10.2337/db24-17-or
ADAM SEAL, STEVEN K. MALIN, ANDREW SCHAFFNER, MICHAEL R. HUBBARD, SARAH K. KEADLE, HANNAH BRUNNER-GAYDOS, ALIA A. ORTIZ, JANE E. NAKAMURA, CLARA MCMAHON, RACHEL BARNETT, ANITA H. KELLEHER, KELLY A. BENNION, SUZANNE PHELAN, TODD HAGOBIAN
Introduction: Bisphenol A (BPA) is a synthetic chemical widely used in consumer goods and is linked to Type 2 diabetes progression in observational studies. No experimental studies have examined whether BPA promotes reductions in peripheral insulin sensitivity. Objective: To determine the effects of oral BPA administration on peripheral insulin sensitivity. Methods: Forty non-habitually active, healthy adults (22 F, 18 M; 21.3 ± 2.5 yr; 22.1 ± 2.3 kg/m2; 85% Non-Hispanic White) completed a 2-day baseline energy balance diet low in bisphenols during which urine, blood, and peripheral insulin sensitivity (i.e., glucose infusion rate/steady-state plasma insulin) via 120 min euglycemic hyperinsulinemic clamp technique (40 mU/m2/min; 90 mg/dL) were assessed. Participants were then randomly assigned, in a double-blinded fashion, to a 4-day energy balance diet plus oral BPA administration at 50 μg/kg body weight (BPA-50) or 4-day energy balance diet plus oral placebo (PL) administration. Outcomes were reassessed using a repeated measures ANOVA adjusting for baseline sex, BMI, physical activity, and ethnicity. Results: From baseline to 4-days, body weight was not significantly (P>0.05) different between PL (mean ± SEM; 66.7 ± 2.5, 66.2 ± 2.5 kg) and BPA-50 (66.7 ± 2.5, 66.7± 2.5 kg). From baseline to 4-days, fasting blood glucose was not significantly (P > 0.05) different between PL (95 ± 2, 88 ± 2 mg/dL) and BPA-50 (92 ± 2, 92 ± 2 mg/dL). Compared to PL urine BPA was significantly higher (P<0.05) following BPA-50. From baseline to 4-days, peripheral insulin sensitivity significantly (P=0.01) decreased in BPA-50 (0.11 ± 0.01, 0.10 ± 0.01 mg/kg/min/uU/ml) and remained stable in PL (0.09 ± 0.01, 0.10 ± 0.01 mg/kg/min/uU/ml). Conclusion: BPA administration decreased peripheral insulin sensitivity after four days. These data provide the first experimental evidence that BPA administration may increase Type 2 diabetes risk. Supported by American Diabetes Association grant #1-19-ICTS-044. Disclosure A. Seal: None. S.K. Malin: None. A. Schaffner: None. M.R. Hubbard: None. S.K. Keadle: None. H. Brunner-Gaydos: None. A.A. Ortiz: None. J.E. Nakamura: None. C. McMahon: None. R. Barnett: None. A.H. Kelleher: None. K.A. Bennion: None. S. Phelan: Research Support; Weight Watchers International. T. Hagobian: None. Funding American Diabetes Association (1-19-ICTS-044)
导言:双酚 A(BPA)是一种广泛用于消费品的合成化学物质,在观察性研究中,它与 2 型糖尿病的进展有关。目前还没有实验研究探讨双酚 A 是否会降低外周胰岛素敏感性。研究目的确定口服双酚 A 对外周胰岛素敏感性的影响。方法:40 名非习惯性活跃的健康成年人(22 名女性,18 名男性;21.3 ± 2.5 岁;22.1 ± 2.3 kg/m2;85% 非西班牙裔白人)完成了为期 2 天的低双酚基线能量平衡饮食,在此期间,通过 120 分钟优格高胰岛素血症钳夹技术(40 mU/m2/min;90 mg/dL)对尿液、血液和外周胰岛素敏感性(即葡萄糖输注率/稳态血浆胰岛素)进行了评估。然后以双盲方式将参与者随机分配到 4 天能量平衡饮食加口服 50 μg/kg 体重的双酚 A(BPA-50)或 4 天能量平衡饮食加口服安慰剂(PL)。采用重复测量方差分析对结果进行重新评估,并对基线性别、体重指数、体力活动和种族进行调整。结果从基线到 4 天,PL(平均值 ± SEM;66.7 ± 2.5、66.2 ± 2.5 千克)和 BPA-50 (66.7 ± 2.5、66.7 ± 2.5 千克)之间的体重差异不大(P>0.05)。从基线到 4 天,PL(95 ± 2,88 ± 2 mg/dL)和 BPA-50 (92 ± 2,92 ± 2 mg/dL)之间的空腹血糖差异不显著(P > 0.05)。与 PL 相比,BPA-50 后尿液中的 BPA 明显更高(P<0.05)。从基线到 4 天,BPA-50 的外周胰岛素敏感性明显下降(P=0.01)(0.11 ± 0.01,0.10 ± 0.01 mg/kg/min/uU/ml),而 PL 的外周胰岛素敏感性保持稳定(0.09 ± 0.01,0.10 ± 0.01 mg/kg/min/uU/ml)。结论给药四天后,双酚 A 会降低外周胰岛素敏感性。这些数据首次提供了实验证据,证明服用双酚 A 可增加 2 型糖尿病风险。由美国糖尿病协会资助 #1-19-ICTS-044。披露 A. Seal:无。S.K. Malin:无。A. Schaffner:无:无。M.R. Hubbard:无。S.K. Keadle:无。H. Brunner-Gaydos:H. Brunner-Gaydos: None.A.A. Ortiz: None.J.E. Nakamura: None.C. McMahon:无。R. Barnett: None.A.H. Kelleher:K.A. Bennion: None.K.A. Bennion:无。S. Phelan:研究支持;Weight Watchers International。T. Hagobian:无。资助机构 美国糖尿病协会 (1-19-ICTS-044)
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引用次数: 0
142-OR: A1C and Average Glucose Discordance—Personalized A1C Improves the Discrepancy, Particularly in Black Individuals 142-OR: A1C 和平均血糖不一致--个性化 A1C 可改善差异,尤其是黑人的差异
IF 7.7 1区 医学 Q1 Medicine Pub Date : 2024-06-21 DOI: 10.2337/db24-142-or
RAMZI AJJAN, TIMOTHY DUNN, YONGJIN XU, PRATIK CHOUDHARY
Introduction: Black individuals with diabetes have greater hypoglycemic hospitalizations, perhaps due to overtreatment of elevated laboratory A1C compared to average glucose (AG), related to altered red blood cell (RBC) biology. Our aim was to evaluate the size of the problem and improve A1C accuracy using a new glycemic marker. Methods: Continuous glucose monitoring (CGM) and bi-monthly A1C were collected in a 26-week study of adults with type 1 or type 2 diabetes across different race groups. RBC personal glycation ratio (PGR) was determined at 12 weeks and used to calculate personalized A1C (pA1C) with this new glycemic marker assessed against paired 56-day AG-derived A1C. Results: Of 811 A1C and AG-derived A1C comparisons in 245 individuals, 34% displayed greater than 0.5% disagreement. This was reduced to 13% using pA1C, with the largest improvement detected in 56 Black individuals (reducing from 42% deviation rate for A1C to 17% for pA1C, Figure). For A1C values <7%, more than 0.5% discrepancy between A1C and AG-derived A1C for the whole group and Black individuals was lowered from 27% and 34%, respectively, to 5% and 9% with pA1C. Conclusion: Clinically significant A1C and AG-derived A1C discordance is common, particularly in Black individuals. Personalized A1C addresses this discrepancy potentially improving clinical management in diabetes and reducing health disparities. Disclosure R. Ajjan: Research Support; Abbott. Speaker's Bureau; Abbott. Advisory Panel; Abbott, AstraZeneca, Novo Nordisk. Speaker's Bureau; Boehringer-Ingelheim. Research Support; Diabetes UK. Advisory Panel; Eli Lilly and Company, Sanofi. T. Dunn: Employee; Abbott. Y. Xu: None. P. Choudhary: Advisory Panel; Abbott, Biolinq. Speaker's Bureau; Dexcom, Inc., Eli Lilly and Company, Novo Nordisk, Sanofi. Advisory Panel; Ypsomed AG, Vertex Pharmaceuticals Incorporated.
导言:与平均血糖(AG)相比,黑人糖尿病患者的低血糖住院率更高,这可能是由于过度治疗实验室 A1C 升高所致,与红细胞(RBC)生物学改变有关。我们的目的是评估问题的严重程度,并使用一种新的血糖标记物提高 A1C 的准确性。方法在一项为期 26 周的研究中,对不同种族的 1 型或 2 型糖尿病成人患者进行了连续血糖监测 (CGM) 和双月 A1C 采集。在 12 周时测定红细胞个人糖化比值 (PGR),并利用这一新的血糖标志物计算个人化 A1C (pA1C),与配对的 56 天 AG 派生 A1C 进行评估。结果:在对 245 人进行的 811 次 A1C 和 AG 导出 A1C 比较中,34% 的比较结果显示差异大于 0.5%。使用 pA1C 后,这一比例降至 13%,其中 56 名黑人的改善幅度最大(A1C 的偏差率从 42% 降至 pA1C 的 17%,如图)。对于 A1C 值<7%,使用 pA1C 后,全组和黑人的 A1C 与 AG 导出的 A1C 之间超过 0.5% 的差异分别从 27% 和 34% 降低到 5% 和 9%。结论临床上明显的 A1C 和 AG 导出 A1C 不一致很常见,尤其是在黑人中。个性化 A1C 可以解决这一差异,从而改善糖尿病的临床管理,减少健康差异。披露 R. Ajjan:研究支持;雅培。Speaker's Bureau; Abbott.顾问团;雅培、阿斯利康、诺和诺德。发言人办公室;勃林格殷格翰公司。研究支持;英国糖尿病协会。顾问团;礼来公司、赛诺菲。T. Dunn:雅培公司雇员。Y. Xu:无。P. Choudhary:顾问团成员;雅培、Biolinq。Speaker's Bureau;Dexcom, Inc.、礼来公司、诺和诺德、赛诺菲。顾问团;Ypsomed AG、Vertex Pharmaceuticals Incorporated。
{"title":"142-OR: A1C and Average Glucose Discordance—Personalized A1C Improves the Discrepancy, Particularly in Black Individuals","authors":"RAMZI AJJAN, TIMOTHY DUNN, YONGJIN XU, PRATIK CHOUDHARY","doi":"10.2337/db24-142-or","DOIUrl":"https://doi.org/10.2337/db24-142-or","url":null,"abstract":"Introduction: Black individuals with diabetes have greater hypoglycemic hospitalizations, perhaps due to overtreatment of elevated laboratory A1C compared to average glucose (AG), related to altered red blood cell (RBC) biology. Our aim was to evaluate the size of the problem and improve A1C accuracy using a new glycemic marker. Methods: Continuous glucose monitoring (CGM) and bi-monthly A1C were collected in a 26-week study of adults with type 1 or type 2 diabetes across different race groups. RBC personal glycation ratio (PGR) was determined at 12 weeks and used to calculate personalized A1C (pA1C) with this new glycemic marker assessed against paired 56-day AG-derived A1C. Results: Of 811 A1C and AG-derived A1C comparisons in 245 individuals, 34% displayed greater than 0.5% disagreement. This was reduced to 13% using pA1C, with the largest improvement detected in 56 Black individuals (reducing from 42% deviation rate for A1C to 17% for pA1C, Figure). For A1C values <7%, more than 0.5% discrepancy between A1C and AG-derived A1C for the whole group and Black individuals was lowered from 27% and 34%, respectively, to 5% and 9% with pA1C. Conclusion: Clinically significant A1C and AG-derived A1C discordance is common, particularly in Black individuals. Personalized A1C addresses this discrepancy potentially improving clinical management in diabetes and reducing health disparities. Disclosure R. Ajjan: Research Support; Abbott. Speaker's Bureau; Abbott. Advisory Panel; Abbott, AstraZeneca, Novo Nordisk. Speaker's Bureau; Boehringer-Ingelheim. Research Support; Diabetes UK. Advisory Panel; Eli Lilly and Company, Sanofi. T. Dunn: Employee; Abbott. Y. Xu: None. P. Choudhary: Advisory Panel; Abbott, Biolinq. Speaker's Bureau; Dexcom, Inc., Eli Lilly and Company, Novo Nordisk, Sanofi. Advisory Panel; Ypsomed AG, Vertex Pharmaceuticals Incorporated.","PeriodicalId":11376,"journal":{"name":"Diabetes","volume":null,"pages":null},"PeriodicalIF":7.7,"publicationDate":"2024-06-21","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141448576","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
920-P: Sodium–Glucose Cotransporter 2 Inhibitor Use and Risk of Dementia and Parkinson’s disease among Patients with Type 2 Diabetes—A Longitudinal, Nationwide, Population-Based Cohort Study 920-P:钠-葡萄糖共转运体 2 抑制剂的使用与 2 型糖尿病患者罹患痴呆症和帕金森病的风险--一项纵向、全国性、基于人群的队列研究
IF 7.7 1区 医学 Q1 Medicine Pub Date : 2024-06-21 DOI: 10.2337/db24-920-p
HAE KYUNG KIM, GEERT J. BIESSELS, MINHEUI YU, JIHOON BAE, ARIM CHOI, MINYOUNG LEE
The efficacy of sodium-glucose cotransporter 2 inhibitor (SGLT2i) in neurologic disorders is not well-established. This study aimed to investigate the association of SGLT2i use with risks of incident dementia and Parkinson’s disease (PD) in patient with type 2 diabetes. Subjects aged ≥ 40 years, diagnosed with type 2 diabetes, and who started antidiabetic drugs from 1 September 2014 and 31 December 2019 were evaluated, using the National Health Insurance Service Database. Propensity score matching (1:1; SGLT2i to other oral antidiabetic drugs [OAD]) produced a cohort of 358,862. Primary outcomes were a composite of dementia from any cause (Alzheimer’s disease [AD], vascular dementia [VaD], and other dementia) and PD. From the 358,862 participants analyzed (mean age, 57.8 years; 57.9% male), 6,837 incident dementia or PD events occurred. Overall, use of SGLT2i was associated with a 22% lower risk for the composite of dementia from any cause and PD than use of other OADs (adjusted HR [aHR], 0.78 [95% CI 0.73─0.83]) with a 6-month lag period. Regarding the individual endpoints, SGLT2i use was associated with reduced risks for AD (aHR, 0.81 [95% CI 0.76─0.87]), VaD (aHR, 0.69 [95% CI 0.60─0.78]), and PD (aHR, 0.80 [95% CI 0.69─0.91]). In this nationwide population-based cohort study, SGLT2i use significantly reduced the risks for dementia and PD in patients with type 2 diabetes independent of various factors including comorbidities and bioclinical parameters. Disclosure H. Kim: None. G.J. Biessels: None. M. Yu: None. J. Bae: None. A. Choi: None. M. Lee: Other Relationship; JW Pharmaceutical Corporation, Boryung Corporation, Eli Lilly and Company, Merck Sharp & Dohme Corp., HK inno.N, Servier Korea, Handok Inc., Daewoong Pharmaceutical, KUKJE PHARM CO., LTD, GC Biopharma Corporation. Funding Korea Health Technology R&D Project through the Korea Health Industry Development Institute (KHIDI), funded by the Ministry of Health & Welfare, Republic of Korea (HR22C141104)2); 'SENTINEL (Severance Endocrinology daTa scIeNcE pLatform)’ program funded by the 2020 Research fund of Department of Internal Medicine, Severance Hospital; Sung-Kil Lim Research Award (4-2018-1215; DUCD000002); Yonsei University College of Medicine (6-2020-0155)
钠-葡萄糖共转运体 2 抑制剂(SGLT2i)对神经系统疾病的疗效尚未得到充分证实。本研究旨在探讨使用 SGLT2i 与 2 型糖尿病患者痴呆症和帕金森病(PD)发病风险的关系。研究利用国家健康保险服务数据库对年龄≥40岁、确诊为2型糖尿病且在2014年9月1日至2019年12月31日期间开始服用抗糖尿病药物的受试者进行了评估。倾向得分匹配(1:1;SGLT2i 与其他口服抗糖尿病药物 [OAD])产生了一个 358,862 人的队列。主要结果是任何原因引起的痴呆(阿尔茨海默病 [AD]、血管性痴呆 [VaD] 和其他痴呆)和帕金森病的复合结果。在分析的 358862 名参与者(平均年龄 57.8 岁;57.9% 为男性)中,发生了 6837 例痴呆或帕金森病事件。总体而言,使用 SGLT2i 与任何原因引起的痴呆和帕金森氏症的复合风险相关性比使用其他 OADs 低 22%(调整 HR [aHR],0.78 [95% CI 0.73-0.83]),滞后期为 6 个月。就单个终点而言,使用 SGLT2i 可降低 AD(aHR,0.81 [95% CI 0.76─0.87])、VaD(aHR,0.69 [95% CI 0.60─0.78])和 PD(aHR,0.80 [95% CI 0.69─0.91])的风险。在这项全国范围的人群队列研究中,使用SGLT2i能显著降低2型糖尿病患者罹患痴呆症和帕金森氏症的风险,不受合并症和生物临床参数等各种因素的影响。披露 H. Kim:无。G.J. Biessels:无。M. Yu:无。J. Bae:无。A. Choi:无。M. Lee:其他关系;JW Pharmaceutical Corporation、Boryung Corporation、Eli Lilly and Company、Merck Sharp & Dohme Corp.、HK inno.N、Servier Korea、Handok Inc.、Daewoong Pharmaceutical、KUKJE PHARM CO.,LTD、GC Biopharma Corporation。资金来源 韩国保健产业振兴院(KHIDI)资助的韩国保健技术研发项目(HR22C141104)2);Severance医院内科2020研究基金资助的 "SENTINEL(Severance Endocrinology daTa scIeNcE pLatform)"项目;Sung-Kil Lim研究奖(4-2018-1215;DUCD000002);延世大学医学院(6-2020-0155)。
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引用次数: 0
1932-LB: Cost-Effectiveness of the National Diabetes Prevention Program—A Real-World, Two-Year Prospective Study 1932-LB: 国家糖尿病预防计划的成本效益--一项为期两年的前瞻性真实世界研究
IF 7.7 1区 医学 Q1 Medicine Pub Date : 2024-06-21 DOI: 10.2337/db24-1932-lb
SHIHCHEN KUO, WEN YE, DI WANG, LAURA N. MCEWEN, CLAUDIA VILLATORO SANTOS, WILLIAM H. HERMAN
Few studies have examined the cost-effectiveness of the National Diabetes Prevention Program (NDPP) in real-world settings. We evaluated the real-world cost-effectiveness of the NDPP in people with prediabetes in a large workforce with employer-sponsored health insurance. We performed individual-level, empirical data analyses using surveys and health insurance claims for 6,179 adult employees, dependents, and retirees with prediabetes who enrolled (n=592) or did not enroll (n=5,587) in the NDPP. We assessed direct medical costs the year before NDPP enrollment/index date (baseline) through 2 years afterward, EQ-5D-5L utility scores at baseline and 2 years afterward, and quality-adjusted life-years (QALYs) over 2 years for NDPP enrollees and non-enrollees. We applied propensity score weighting to adjust for bias due to self-selection for enrollment, multiple imputations to handle missing data, and bootstrap method to produce confidence intervals (CIs). We adopted a health system perspective and discounted costs and QALYs at 3% annually. Costs were expressed in 2020 U.S. dollars. Compared to non-enrollees, the average reduction in direct medical costs per enrollee was $3,979 (95% CI: -$11,962 to $2,019) over 2 years. The cost savings were primarily related to fewer hospitalizations (-$3,016), outpatient visits (-$639), and emergency room visits (-$272) among enrollees. Each enrollee accrued 1.726 QALYs and each non-enrollee accrued 1.702 QALYs over 2 years, representing a gain of 0.024 (95% CI: -0.007 to 0.052) QALY per enrollee. The uncertainty analyses showed a high probability (75%) of cost savings, and an 89% probability of being cost-effective at a willingness-to-pay threshold of $100,000 per QALY gained, for NDPP enrollees versus non-enrollees. In this real-world population with prediabetes, enrollment in the NDPP was likely to provide cost savings and improve quality-adjusted life-expectancy. Further research is warranted to confirm these findings. Disclosure S. Kuo: None. W. Ye: None. D. Wang: None. L.N. McEwen: None. C. Villatoro Santos: None. W.H. Herman: Consultant; Merck Sharp & Dohme Corp. Advisory Panel; American Diabetes Association. Other Relationship; National Institutes of Health. Advisory Panel; National Committee for Quality Assurance. Funding National Institute of Diabetes and Digestive and Kidney Diseases (R01DK109995 and P30DK092926), and Centers for Disease Control and Prevention (U18DP006712)
很少有研究对全国糖尿病预防计划(NDPP)在实际环境中的成本效益进行研究。我们评估了国家糖尿病预防计划在现实世界中的成本效益,该计划针对的是一个由雇主提供医疗保险的大型劳动力群体中的糖尿病前期患者。我们对 6179 名患有糖尿病前期的成年雇员、家属和退休人员进行了个人层面的实证数据分析,这些人参加(人数=592)或未参加(人数=5587)NDPP。我们评估了 NDPP 参保者和未参保者在 NDPP 参保/指数日期(基线)前一年至之后 2 年的直接医疗费用、基线和之后 2 年的 EQ-5D-5L 实用性评分以及 2 年的质量调整生命年 (QALY)。我们采用倾向得分加权法来调整因自我选择加入而产生的偏差,采用多重推定法来处理缺失数据,并采用自举法得出置信区间 (CI)。我们从卫生系统的角度出发,将成本和 QALYs 每年贴现 3%。成本以 2020 年美元表示。与未参保者相比,2 年内每位参保者的直接医疗成本平均减少了 3,979 美元(95% CI:-11,962 美元至 2,019 美元)。节省的费用主要与参保者住院次数(-3,016 美元)、门诊次数(-639 美元)和急诊次数(-272 美元)的减少有关。每名参保者在 2 年内可获得 1.726 QALY,每名非参保者可获得 1.702 QALY,即每名参保者可获得 0.024(95% CI:-0.007 至 0.052)QALY。不确定性分析表明,NDPP 参保者与非参保者相比,成本节约的可能性很高(75%),在每 QALY 收益 100,000 美元的支付意愿阈值下,成本效益的可能性为 89%。在这一现实世界中的糖尿病前期人群中,参加 NDPP 有可能节约成本并提高质量调整寿命。我们需要进一步研究来证实这些发现。披露 S. Kuo:无。W. Ye:无。D. Wang:无。L.N. McEwen:无。C. Villatoro Santos:无。W.H. Herman:顾问;Merck Sharp & Dohme Corp.顾问团;美国糖尿病协会。其他关系;美国国立卫生研究院。顾问团;国家质量保证委员会。国家糖尿病、消化道和肾脏疾病研究所 (R01DK109995 和 P30DK092926) 和美国疾病控制和预防中心 (U18DP006712) 资助
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引用次数: 0
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Diabetes
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