Activity ID
14661Expires
November 10, 2028Format Type
Journal-basedCME Credit
1Fee
$30CME Provider: JAMA
Description of CME Course
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
Disclaimers
1. This activity is accredited by the American Medical Association.
2. This activity is free to AMA members.
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Educational Objectives
To identify the key insights or developments described in this article.
Keywords
Diabetes, Diabetes, Diabetes and Endocrinology, Diabetes and Endocrinology, Obstetrics
Competencies
Medical Knowledge
CME Credit Type
AMA PRA Category 1 Credit
DOI
10.1001/jama.2025.19578