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Day-and-Night Closed-Loop Insulin Delivery in a Broad Population of Pregnant Women With Type 1 Diabetes: A Randomized Controlled Crossover Trial

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Stewart, Zoe A., Wilinska, Malgorzata E., Hartnell, Sara, O’Neil, Leanne K., Rayman, Gerry, Scott, Eleanor M., Barnard, Katharine, Farrington, Conor, Hovorka, Roman, Murphy, Helen R.·2018·Diabetes Care
DOI 10.2337/dc17-2534
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Abstract

OBJECTIVE Despite advances in technology, optimal glucose control remains elusive and neonatal complications remain 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], and 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 8 [range 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.

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Authors
Stewart, Z. A., Wilinska, M. E., Hartnell, S., O’Neil, L. K., Rayman, G., Scott, E. M., Barnard, K., Farrington, C., Hovorka, R., & Murphy, H. R.
Affiliations
  • University of Cambridge (GB)
  • Cambridge University Hospitals NHS Foundation Trust (GB)
  • Elsie-Bertram Diabetes Centre, Norfolk and Norwich University Hospitals NHS Foundation Trust, Norwich, U.K.
  • Ipswich Hospital (GB)
  • University of Leeds (GB)
  • Bournemouth University (GB)
  • University of East Anglia (GB)
Corresponding author
Murphy, Helen R.
ORCID
Venue
Diabetes Care
Publisher
American Diabetes Association
Published
2018-03-13
Volume
41
Issue
7
Pages
1391-1399
ISSN
  • 0149-5992 (ISSN-L)
  • 1935-5548
DOI
10.2337/dc17-2534
OpenAlex
W2794206338
Cited by
168
References
26
Citations by year
2026: 9 · 2025: 27 · 2024: 20 · 2023: 26 · 2022: 19 · 2021: 21 · 2020: 17 · 2019: 21 · 2018: 8
FWCI
13.32
Type
journal article
Language
en
Open access
Licence
www.diabetesjournals.org/content/license (vor, 101 d)
Locations
  • Diabetes Care (publishedVersion)
  • PubMed (publishedVersion)
  • White Rose Research Online (University of Leeds, The University of Sheffield, University of York) (acceptedVersion)
  • UEA Digital Repository (University of East Anglia) (acceptedVersion)
  • Apollo (University of Cambridge) (submittedVersion)
  • Apollo
Funders
  • Gates Cambridge Trust (PhD fellowship)
  • National Institute for Health Research (CDF-2013-06-035)
Topics
  • Health Sciences › Medicine › Endocrinology, Diabetes and Metabolism › Diabetes Management and Research
  • Health Sciences › Medicine › Obstetrics and Gynecology › Gestational Diabetes Research and Management
  • Health Sciences › Medicine › Endocrinology, Diabetes and Metabolism › Diabetes Management and Education
Keywords
type 1 diabetes in pregnancy, artificial pancreas, continuous glucose monitoring, sensor-augmented pump, glycemic control, hypoglycemia, nocturnal hypoglycemia, hyperglycemia, neonatal outcomes, insulin pump therapy, crossover trial, low blood glucose index, HbA1c, neonatal hypoglycemia, neonatal hyperbilirubinemia, neonatal hypocalcemia, neonatal hypotension
MeSH terms
Adolescent, Adult, Blood Glucose, Circadian Rhythm, Diabetes Mellitus, Type 1, Female, Humans, Hyperinsulinism, Hypoglycemia, Hypoglycemic Agents, Insulin, Insulin Infusion Systems, Middle Aged, Pregnancy, Pregnancy in Diabetics, Pregnancy Outcome, Time Factors, Treatment Outcome, Cross-Over Studies, Delivery, Obstetric, Postpartum Period, Young Adult

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