2084-LB: A Randomized Multicenter Trial of Hybrid Closed-Loop Insulin Therapy with Control-IQ Technology in Type 1 Diabetes in Pregnancy

IF 7.5 1区医学 Q1 ENDOCRINOLOGY & METABOLISM

Diabetes Pub Date : 2025-06-20 DOI:10.2337/db25-2084-lb

LOIS E. DONOVAN, PATRICIA LEMIEUX, AMY DUNLOP, JENNIFER M. YAMAMOTO, HELEN R. MURPHY, DAVID SIMMONS, RHONDA C. BELL, KATHLEEN CHAPUT, JAMIE L. BENHAM, GLYNIS P. ROSS, KARA NERENBERG, KHORSHID MOHAMMAD, BRUCE A. PERKINS, JANE E. BOOTH, HENRY N. NTANDA, GEORGE TOMLINSON, DENICE FEIG

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引用次数: 0

Abstract

Introduction and Objective: The efficacy of hybrid closed-loop insulin therapy (HCL) in pregnancy varies by system. Our objective was to assess the efficacy in pregnancy of a HCL that is in common use outside of pregnancy. Methods: This multicenter, open-label trial randomized pregnant women with type 1 diabetes (T1D) and early pregnancy A1C of 6.2-10%, at 14 sites in Canada and Australia, to start HCL (t:slim X2 insulin pump with Control-IQ technology with Dexcom G6 sensor) by 16 weeks gestation or continue with standard care with continuous glucose monitoring (CGM). Use of the lowest target range (sleep activity) was recommended throughout the day and night with the optional use of the highest target range for exercise. The primary outcome was the percentage of time that glucose was in the pregnancy range of 63 to 140mg/dL [3.5 to 7.8mmol/L] (TIRp) as measured by CGM from 16 to 34weeks +6days gestation adjusted for site, baseline TIRp and baseline mode of insulin delivery, using intention-to-treat principles. Secondary outcomes included time above 140mg/dL (7.8mmol/L), time below 63mg/dL (3.5mmol/L), mean glucose, safety events and pregnancy outcomes. Results: A total of 91 women (mean ± SD: age 31.7 ± 5.2 years, diabetes duration 19.0 ± 8.1 years, early pregnancy A1C 7.4 ± 1.0%) were randomized (46 to HCL and 45 to standard care). The mean adjusted TIRp was 12.6 percentage points (95% CI 9.9,15.2; p<0.001) higher in HCL than standard care (65.4 ± 9.5% versus 50.3 ± 13.9%, respectively) with 11.4 percentage points less time above range (95% CI 8.6,14.2 p<0.001) and 1.04 percentage points less time below 63mg/dL (95%CI 0.6,1.48 p<0.001). The adjusted mean glucose was 11.2mg/dL (0.62 mmol/L) lower with HCL versus standard care (95%CI 7.2,16.2 p<0.001). There was 1 episode of severe hypoglycemia with HCL and 0 with standard care and 2 episodes of diabetic ketoacidosis in each of the trial arms. Conclusion: This HCL resulted in 3 more hours/day spent in TIRp in T1D pregnancy compared to standard care. No safety concerns arose. Disclosure L.E. Donovan: Other Relationship; Medtronic, Dexcom, Inc., Tandem Diabetes Care, Inc, Inner Analytics. P. Lemieux: Advisory Panel; Dexcom, Inc. A. Dunlop: None. J.M. Yamamoto: Other Relationship; Abbott. H.R. Murphy: Research Support; Abbott, Dexcom, Inc. Advisory Panel; Medtronic, Ypsomed AG. Speaker's Bureau; Eli Lilly and Company, Dexcom, Inc., Ypsomed AG, Novo Nordisk, Sanofi. D. Simmons: Research Support; Novo Nordisk, AMSL. Other Relationship; Abbott, Abbott, Boehringer-Ingelheim. Speaker's Bureau; Ascensia Diabetes Care. R.C. Bell: None. K. Chaput: None. J.L. Benham: None. G.P. Ross: None. K. Nerenberg: None. K. Mohammad: None. B.A. Perkins: Other Relationship; Abbott, Novo Nordisk, Sanofi. Advisory Panel; Abbott, Insulet Corporation, Sanofi, Novo Nordisk, Nephris, Vertex Pharmaceuticals Incorporated. Research Support; Novo Nordisk. J.E. Booth: None. H.N. Ntanda: None. G. Tomlinson: None. D. Feig: Other Relationship; Novo Nordisk. Consultant; Ypsomed. Funding Diabetes Canada (OG-3-21-5570-LD); Australia Medical Research Future Fund (MRFF); lnternational Clinical Trial Collaboration (2022/MRF2023992)

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2084-LB：一项随机多中心试验，混合闭环胰岛素治疗与控制- iq技术在妊娠期1型糖尿病

前言与目的：混合闭环胰岛素治疗（HCL）在妊娠期的疗效因系统而异。我们的目的是评估妊娠期外常用的HCL在妊娠期的疗效。方法：这项多中心、开放标签的试验随机选择加拿大和澳大利亚14个地点的1型糖尿病（T1D）和早期妊娠A1C为6.2-10%的孕妇，在妊娠16周开始使用HCL（采用Control-IQ技术和Dexcom G6传感器的t:slim X2胰岛素泵）或继续接受持续血糖监测（CGM）的标准治疗。建议在白天和晚上使用最低目标范围（睡眠活动），并可选择使用最高目标范围进行锻炼。主要终点是妊娠16至34周+6天期间葡萄糖在妊娠63至140mg/dL[3.5至7.8mmol/L] （TIRp）范围内的时间百分比，根据地点、基线TIRp和基线胰岛素输送方式调整，使用意向治疗原则。次要结局包括时间高于140mg/dL （7.8mmol/L）、时间低于63mg/dL （3.5mmol/L）、平均血糖、安全事件和妊娠结局。结果：共有91名女性（平均±SD：年龄31.7±5.2岁，糖尿病病程19.0±8.1年，早孕A1C 7.4±1.0%）被随机分配（46名接受HCL治疗，45名接受标准治疗）。校正后的平均TIRp为12.6个百分点(95% CI 9.9,15.2；HCL高于标准护理（分别为65.4±9.5%和50.3±13.9%），高于范围的时间减少11.4个百分点（95%CI 8.6,14.2 p<0.001），低于63mg/dL的时间减少1.04个百分点（95%CI 0.6,1.48 p<0.001）。与标准护理相比，HCL组调整后的平均血糖降低11.2mg/dL (0.62 mmol/L) （95%CI 7.2,16.2;lt;0.001）。在每个试验组中，有1例HCL严重低血糖发作，0例标准治疗，2例糖尿病酮症酸中毒发作。结论：与标准治疗相比，这种HCL导致T1D妊娠患者TIRp治疗时间每天增加3小时。没有出现安全问题。l·e·多诺万：其他关系；Medtronic, Dexcom, Inc., Tandem Diabetes Care, Inc., Inner AnalyticsP. Lemieux：咨询小组；, Dexcom公司将公司。邓洛普：没有。山本J.M.：其他关系；阿伯特。H.R. Murphy：研究支持；雅培，Dexcom公司顾问小组;美敦力，Ypsomed AG。演讲者的局;礼来公司、Dexcom公司、Ypsomed AG、诺和诺德、赛诺菲。D. Simmons：研究支持；诺和诺德，AMSL。其他关系;雅培，雅培，勃林格殷格翰。演讲者的局;Ascensia Diabetes Care。贝尔：没有。查普特：没有。J.L. Benham：没有。gp。罗斯：没有。K.尼伯格：没有。穆罕默德：没有。B.A. Perkins：其他关系；雅培，诺和诺德，赛诺菲。顾问小组;雅培，胰岛素公司，赛诺菲，诺和诺德，Nephris， Vertex制药公司。研究支持;诺和诺德公司。J.E. Booth：没有。H.N.坦达：没有。汤姆林森：没有。D.菲格：其他关系；诺和诺德公司。顾问;Ypsomed。资助加拿大糖尿病（OG-3-21-5570-LD）；澳大利亚医学研究未来基金；国际临床试验合作（2022/MRF2023992）

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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.