{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,11,6]],"date-time":"2026-11-06T22:20:25Z","timestamp":1794003625293,"version":"4.8.0"},"reference-count":31,"publisher":"American Medical Association (AMA)","issue":"24","content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["JAMA"],"published-print":{"date-parts":[[2025,12,23]]},"abstract":"\n Importance<\/jats:title>\n 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.<\/jats:p>\n <\/jats:sec>\n \n Objective<\/jats:title>\n To assess the efficacy of a closed-loop system in pregnancy.<\/jats:p>\n <\/jats:sec>\n \n Design, Setting, and Participants<\/jats:title>\n Open-label trial enrolling pregnant women with type 1 diabetes at 14 clinical centers in Canada and Australia before 14 weeks\u2019 gestation with follow-up until 6 weeks postpartum. Enrollment occurred between June 2021 and July 2024 and follow-up was completed in March 2025.<\/jats:p>\n <\/jats:sec>\n \n Interventions<\/jats:title>\n Participants were randomized 1:1 to closed-loop therapy (n\u2009=\u200946) or standard care (insulin pump or multiple daily insulin injections) (n\u2009=\u200945) with continuous glucose monitoring.<\/jats:p>\n <\/jats:sec>\n \n Main Outcomes and Measures<\/jats:title>\n 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\u2019 gestation.<\/jats:p>\n <\/jats:sec>\n \n Results<\/jats:title>\n \n 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 A\n 1c<\/jats:sub>\n , 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\u2019 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;\n P<\/jats:italic>\n \u2009&amp;lt;\u2009.001). 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.\n <\/jats:p>\n <\/jats:sec>\n \n Conclusion and Relevance<\/jats:title>\n 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.<\/jats:p>\n <\/jats:sec>\n \n Trial Registration<\/jats:title>\n \n ClinicalTrials.gov Identifier:\n NCT04902378<\/jats:ext-link>\n <\/jats:p>\n <\/jats:sec>","DOI":"10.1001\/jama.2025.19578","type":"journal-article","created":{"date-parts":[[2025,10,24]],"date-time":"2025-10-24T15:30:35Z","timestamp":1761319835000},"page":"2176","source":"Crossref","is-referenced-by-count":31,"title":["Closed-Loop Insulin Delivery in Type 1 Diabetes in Pregnancy"],"prefix":"10.1001","volume":"334","author":[{"given":"Lois E.","family":"Donovan","sequence":"first","affiliation":[{"name":"Department of Medicine, Cumming School of Medicine, University of Calgary, Calgary, Alberta, Canada"},{"name":"Department of Obstetrics and Gynecology, Cumming School of Medicine, University of Calgary, Calgary, Alberta, Canada"},{"name":"Alberta Children\u2019s Hospital Research Institute, Calgary, Alberta, 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