Closed-Loop insulin delivery during pregnancy in women with type 1 diabetes

Stewart, Zoe A. and Wilinska, Malgorzata E. and Hartnell, Sara and Temple, Rosemary C. and Rayman, Gerry and Stanley, Katharine P. and Simmons, David and Law, Graham and Scott, Eleanor M. and Hovorka, Roman (2016) Closed-Loop insulin delivery during pregnancy in women with type 1 diabetes. New England Journal of Medicine, 375 (7). pp. 644-654. ISSN 0028-4793

Full content URL: http://doi.org/10.1056/NEJMoa1602494

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Closed-Loop insulin delivery during pregnancy in women with type 1 diabetes
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Abstract

BACKGROUND In patients with type 1 diabetes who are not pregnant, closed-loop (automated) insulin delivery can provide better glycemic control than sensor- Augmented pump therapy, but data are lacking on the efficacy, safety, and feasibility of closed-loop therapy during pregnancy. METHODS We performed an open-label, randomized, crossover study comparing overnight closed-loop therapy with sensor- Augmented pump therapy, followed by a continuation phase in which the closed-loop system was used day and night. Sixteen pregnant women with type 1 diabetes completed 4 weeks of closed-loop pump therapy (intervention) and sensor- Augmented pump therapy (control) in random order. During the continuation phase, 14 of the participants used the closed-loop system day and night until delivery. The primary outcome was the percentage of time that overnight glucose levels were within the target range (63 to 140 mg per deciliter 3.5 to 7.8 mmol per liter). RESULTS The percentage of time that overnight glucose levels were in the target range was higher during closed-loop therapy than during control therapy (74.7% vs. 59.5%; absolute difference, 15.2 percentage points; 95% confidence interval, 6.1 to 24.2; P = 0.002). The overnight mean glucose level was lower during closed-loop therapy than during control therapy (119 vs. 133 mg per deciliter 6.6 vs. 7.4 mmol per liter, P = 0.009). There were no significant differences between closed-loop and control therapy in the percentage of time in which glucose levels were below the target range (1.3% and 1.9%, respectively; P = 0.28), in insulin doses, or in adverseevent rates. During the continuation phase (up to 14.6 additional weeks, including antenatal hospitalizations, labor, and delivery), glucose levels were in the target range 68.7% of the time; the mean glucose level was 126 mg per deciliter (7.0 mmol per liter). No episodes of severe hypoglycemia requiring third-party assistance occurred during either phase. CONCLUSIONS Overnight closed-loop therapy resulted in better glucose control than sensor- Augmented pump therapy in pregnant women with type 1 diabetes. Women receiving day- And-night closed-loop therapy maintained glycemic control during a high proportion of the time in a period that encompassed antenatal hospital admission, labor, and delivery. © Copyright 2016 Massachusetts Medical Society. All rights reserved.

Keywords:antidiabetic agent, glucose blood level, insulin, adult, blood, clinical trial, comparative study, controlled study, crossover procedure, Diabetes Mellitus, Type 1, female, human, insulin infusion, metabolism, multicenter study, pregnancy, Pregnancy in Diabetics, randomized controlled trial, Adult, Blood Glucose, Cross-Over Studies, Humans, Hypoglycemic Agents, Insulin, Insulin Infusion Systems, NotOAChecked
Subjects:B Subjects allied to Medicine > B100 Anatomy, Physiology and Pathology
Divisions:College of Social Science > School of Health & Social Care
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ID Code:26509
Deposited On:20 Apr 2017 08:40

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