• Tara T M Lee, Corinne Collett, Simon Bergford, Sara Hartnell, Eleanor M Scott, Robert S Lindsay, Katharine F Hunt, David R McCance, Katharine Barnard-Kelly, David Rankin, Julia Lawton, Rebecca M Reynolds, Emma Flanagan, Matthew Hammond, Lee Shepstone, Malgorzata E Wilinska, Judy Sibayan, Craig Kollman, Roy Beck, Roman Hovorka, Helen R Murphy, and AiDAPT Collaborative Group.
• From the Norfolk and Norwich University Hospitals NHS Foundation Trust (T.T.M.L., H.R.M.) and the Norwich Clinical Trials Unit (C.C., E.F., M.H., L.S.), Norwich Medical School (T.T.M.L., H.R.M.), University of East Anglia, Norwich, Cambridge University Hospitals NHS Foundation Trust (S.H.), and the Wellcome-MRC Institute of Metabolic Science, University of Cambridge (M.E.W., R.H.), Cambridge, the Leeds Institute of Cardiovascular and Metabolic Medicine, University of Leeds, Leeds (E.M.S.), the Institute of Cardiovascular and Medical Sciences, University of Glasgow, Glasgow (R.S.L.), King's College Hospital NHS Foundation Trust, London (K.F.H.), the Regional Centre for Endocrinology and Diabetes, Royal Victoria Hospital, Belfast (D.R.M.), Barnard Health Research, Southampton (K.B.-K.), and the Usher Institute (D.R., J.L.) and the Centre for Cardiovascular Science (R.M.R.), University of Edinburgh, Edinburgh - all in the United Kingdom; and the Jaeb Center for Health Research, Tampa, FL (S.B., J.S., C.K., R.B.).
• N. Engl. J. Med. 2023 Oct 26; 389 (17): 156615781566-1578.

BackgroundHybrid closed-loop insulin therapy has shown promise for management of type 1 diabetes during pregnancy; however, its efficacy is unclear.MethodsIn this multicenter, controlled trial, we randomly assigned pregnant women with type 1 diabetes and a glycated hemoglobin level of at least 6.5% at nine sites in the United Kingdom to receive standard insulin therapy or hybrid closed-loop therapy, with both groups using continuous glucose monitoring. The primary outcome was the percentage of time in the pregnancy-specific target glucose range (63 to 140 mg per deciliter [3.5 to 7.8 mmol per liter]) as measured by continuous glucose monitoring from 16 weeks' gestation until delivery. Analyses were performed according to the intention-to-treat principle. Key secondary outcomes were the percentage of time spent in a hyperglycemic state (glucose level >140 mg per deciliter), overnight time in the target range, the glycated hemoglobin level, and safety events.ResultsA total of 124 participants with a mean (±SD) age of 31.1±5.3 years and a mean baseline glycated hemoglobin level of 7.7±1.2% underwent randomization. The mean percentage of time that the maternal glucose level was in the target range was 68.2±10.5% in the closed-loop group and 55.6±12.5% in the standard-care group (mean adjusted difference, 10.5 percentage points; 95% confidence interval [CI], 7.0 to 14.0; P<0.001). Results for the secondary outcomes were consistent with those of the primary outcome; participants in the closed-loop group spent less time in a hyperglycemic state than those in the standard-care group (difference, -10.2 percentage points; 95% CI, -13.8 to -6.6); had more overnight time in the target range (difference, 12.3 percentage points; 95% CI, 8.3 to 16.2), and had lower glycated hemoglobin levels (difference, -0.31 percentage points; 95% CI, -0.50 to -0.12). Little time was spent in a hypoglycemic state. No unanticipated safety problems associated with the use of closed-loop therapy during pregnancy occurred (6 instances of severe hypoglycemia, vs. 5 in the standard-care group; 1 instance of diabetic ketoacidosis in each group; and 12 device-related adverse events in the closed-loop group, 7 related to closed-loop therapy).ConclusionsHybrid closed-loop therapy significantly improved maternal glycemic control during pregnancy complicated by type 1 diabetes. (Funded by the Efficacy and Mechanism Evaluation Program; AiDAPT ISRCTN Registry number, ISRCTN56898625.).Copyright © 2023 Massachusetts Medical Society.

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