1. Automated Insulin Delivery in Women with Pregnancy Complicated by Type 1 Diabetes.
- Author
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Lee TTM, Collett C, Bergford S, Hartnell S, Scott EM, Lindsay RS, Hunt KF, McCance DR, Barnard-Kelly K, Rankin D, Lawton J, Reynolds RM, Flanagan E, Hammond M, Shepstone L, Wilinska ME, Sibayan J, Kollman C, Beck R, Hovorka R, and Murphy HR
- Subjects
- Adult, Female, Humans, Pregnancy, Blood Glucose Self-Monitoring, Glycated Hemoglobin analysis, Treatment Outcome, Blood Glucose analysis, Diabetes Mellitus, Type 1 blood, Diabetes Mellitus, Type 1 complications, Diabetes Mellitus, Type 1 drug therapy, Hypoglycemic Agents administration & dosage, Hypoglycemic Agents adverse effects, Hypoglycemic Agents therapeutic use, Insulin administration & dosage, Insulin adverse effects, Insulin therapeutic use, Insulin Infusion Systems adverse effects, Pregnancy in Diabetics blood, Pregnancy in Diabetics drug therapy
- Abstract
Background: Hybrid closed-loop insulin therapy has shown promise for management of type 1 diabetes during pregnancy; however, its efficacy is unclear., Methods: In 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., Results: A 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)., Conclusions: Hybrid 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.)
- Published
- 2023
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