Day-and-night closed-loop in a broad population of pregnant women with type 1 diabetes: a randomized controlled crossover trial

Stewart, Zoe A., Wilinska, Malgorzata E., Hartnell, Sara, O’Neil, Leanne K, Rayman, Gerry, Scott, Eleanor M., Barnard, Katharine, Farrington, Conor, Hovorka, Roman and Murphy, Helen R. (2018) Day-and-night closed-loop in a broad population of pregnant women with type 1 diabetes: a randomized controlled crossover trial. Diabetes Care, 41 (4). pp. 1391-1399. ISSN 0149-5992

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Abstract

OBJECTIVE Despite advances in technology, optimal glucose control remains elusive and neonatal complications ubiquitous in type 1 diabetes (T1D) pregnancy. Our aim was to examine the safety, efficacy, and longer-term feasibility of day-and-night closed-loop insulin delivery.  RESEARCH DESIGN AND METHODS We recruited 16 pregnant women (mean [SD]: age 32.8 [5.0] years, T1D duration 19.4 [10.2] years, HbA1c 8.0% [1.1%], BMI 26.6 [4.4] kg/m2) to an open-label, randomized, crossover trial. Participants completed 28 days of closed-loop and sensor-augmented pump (SAP) insulin delivery separated by a washout period. Afterward, participants could continue to use the closed-loop system up to 6 weeks postpartum. The primary end point was the proportion of time with glucose levels within the target range (63–140 mg/dL).  RESULTS The proportion of time with glucose levels within target was comparable during closed-loop and SAP insulin delivery (62.3 vs. 60.1% [95% CI −4.1 to 8.3%]; P = 0.47). Mean glucose and time spent hyperglycemic >140 mg/dL also did not differ (131.4 vs. 131.4 mg/dL [P = 0.85] and 36.6 vs. 36.1% [P = 0.86], respectively). During closed-loop, fewer hypoglycemic episodes occurred (median [range] 8 [1–17] vs. 12.5 [1–53] over 28 days; P = 0.04) and less time at <63 mg/dL (1.6 vs. 2.7%; P = 0.02). Hypoglycemia <50 mg/dL (0.24 vs. 0.47%; P = 0.03) and low blood glucose index (1.0 vs. 1.4; P = 0.01) were lower. Less nocturnal hypoglycemia (2300–0700 h) during closed-loop therapy (1.1 vs. 2.7%; P = 0.008) and a trend toward higher overnight time in target (67.7 vs. 60.6%; P = 0.06) were found.  CONCLUSIONS Closed-loop insulin delivery was associated with comparable glucose control and significantly less hypoglycemia than SAP therapy. Larger, longer duration multicenter trials are now indicated to determine clinical efficacy of closed-loop insulin delivery in T1D pregnancy and the impact on neonatal outcomes.

Item Type: Article
Faculty \ School: Faculty of Medicine and Health Sciences > Norwich Medical School
Depositing User: Pure Connector
Date Deposited: 19 Apr 2018 09:30
Last Modified: 08 May 2020 23:53
URI: https://ueaeprints.uea.ac.uk/id/eprint/66804
DOI: 10.2337/dc17-2534

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