妊娠1型糖尿病的闭环胰岛素给药：CIRCUIT随机临床试验
Closed-Loop Insulin Delivery in Type 1 Diabetes in Pregnancy: The CIRCUIT Randomized Clinical Trial.
作者信息
Donovan Lois E, Lemieux Patricia, Dunlop Amy D, Yamamoto Jennifer M, Murphy Helen R, Simmons David, Bell Rhonda C, Chaput Kathleen H, Benham Jamie L, Ross Glynis P, Nerenberg Kara A, Booth Jane E, Perkins Bruce A, Mohammad Khorshid, Ntanda Henry N, King James A, Tomlinson George, Feig Denice S
机构信息
Department of Medicine, Cumming School of Medicine, University of Calgary, Calgary, Alberta, Canada.
Department of Obstetrics and Gynecology, Cumming School of Medicine, University of Calgary, Calgary, Alberta, Canada.
出版信息
JAMA. 2025 Dec 23;334(24):2176-2185. doi: 10.1001/jama.2025.19578.
IMPORTANCE
Hyperglycemia-related pregnancy complications occur in 50% of pregnant women with type 1 diabetes. Closed-loop insulin systems improve glycemia outside of pregnancy but have had limited testing in pregnancy.
OBJECTIVE
To assess the efficacy of a closed-loop system in pregnancy.
DESIGN, SETTING, AND PARTICIPANTS: Open-label trial enrolling pregnant women with type 1 diabetes at 14 clinical centers in Canada and Australia before 14 weeks' gestation with follow-up until 6 weeks postpartum. Enrollment occurred between June 2021 and July 2024 and follow-up was completed in March 2025.
INTERVENTIONS
Participants were randomized 1:1 to closed-loop therapy (n = 46) or standard care (insulin pump or multiple daily insulin injections) (n = 45) with continuous glucose monitoring.
MAIN OUTCOMES AND MEASURES
The primary outcome was the percentage of time spent in the pregnancy-specific glucose range (63-140 mg/dL), measured by continuous glucose monitoring from 16 to 34 weeks' gestation.
RESULTS
Among 94 enrolled participants, 3 experienced pregnancy loss prior to randomization, 91 were randomized (mean age, 31.7 [SD, 5.2] years; early pregnancy hemoglobin A1c, 7.4% [SD, 1.0%]), and 88 were included in the primary analysis. The mean percentage of time spent in the pregnancy-specific glucose range from 16 to 34 weeks' gestation was 65.4% in the closed-loop group and 50.3% in the standard care group (mean adjusted difference, 12.5 [95% CI, 9.5-15.6] percentage points; P < .001). There was 1 episode of severe hypoglycemia in the closed-loop group, and there were 2 episodes of diabetic ketoacidosis in the closed-loop group and 1 in the standard care group.
CONCLUSION AND RELEVANCE
Pregnant women with type 1 diabetes using a closed-loop system spent significantly more time in the pregnancy-specific glucose range than those receiving standard care. These findings support the use of this closed-loop system in pregnant women with type 1 diabetes.
TRIAL REGISTRATION
ClinicalTrials.gov Identifier: NCT04902378.
重要性
50%的1型糖尿病孕妇会出现与高血糖相关的妊娠并发症。闭环胰岛素系统可改善非孕期血糖水平，但在孕期的测试有限。
目的
评估闭环系统在孕期的疗效。
设计、地点和参与者：开放标签试验，在加拿大和澳大利亚的14个临床中心招募妊娠14周前的1型糖尿病孕妇，随访至产后6周。招募时间为2021年6月至2024年7月，随访于2025年3月完成。
干预措施
参与者按1:1随机分为闭环治疗组（n = 46）或标准治疗组（胰岛素泵或每日多次胰岛素注射）（n = 45），并进行持续血糖监测。
主要结局和测量指标
主要结局是在妊娠特定血糖范围（63 - 140 mg/dL）内的时间百分比，通过妊娠16至34周的持续血糖监测来测量。
结果
在94名登记参与者中，3人在随机分组前发生妊娠丢失，91人被随机分组（平均年龄31.7 [标准差，5.2]岁；孕早期糖化血红蛋白7.4% [标准差，1.0%]），88人纳入主要分析。妊娠16至34周期间，闭环组在妊娠特定血糖范围内的平均时间百分比为65.4%，标准治疗组为50.3%（平均调整差异，12.5 [95%置信区间，9.5 - 15.6]个百分点；P <.001）。闭环组有1次严重低血糖事件，闭环组有2次糖尿病酮症酸中毒事件，标准治疗组有1次。
结论和相关性
使用闭环系统的1型糖尿病孕妇在妊娠特定血糖范围内的时间明显多于接受标准治疗的孕妇。这些发现支持在1型糖尿病孕妇中使用这种闭环系统。
试验注册
ClinicalTrials.gov标识符：NCT04902378。
Zotero 插件