Closed-Loop Insulin Delivery during Pregnancy in Women with Type 1 Diabetes
Open accessAbstract
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 adverse-event 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. (Funded by the National Institute for Health Research and others; Current Controlled Trials number, ISRCTN71510001.).
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First longitudinal CGM data demonstrated a 13 percentage point increase in TIR (43% to 56% TIR 70-140 mg/dL).
“The first longitudinal CGM data demonstrated a 13percentage point increase in TIR (43% to 56% TIR 70-140 mg/dL [3.9-7.8 mmol/L]) (61).”
From Clinical Targets for Continuous Glucose Monitoring Data Interpretation: Recommendations From the International Consensus on Time in Range (2019) · cites this paper as [61]
The Study Outcomes report different CGM time-in-range results: 59.5% to 74.7% overnight and 56.8% to 66.3% over 24 hours with closed-loop therapy. The paper defines its target range as 63–140 mg/dL, not 70–140 mg/dL; it does not report the claimed increase from 43% to 56%. (LLM, conf=0.88)
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Experimental — accuracy not yet measuredPregnant women with type 2 diabetes spend one third less time hyperglycemic than women with type 1 diabetes and achieve TIR of 90%.
“More data are needed to define the clinical CGM targets for pregnant women with type 2 diabetes, who spend one third less time hyperglycemic than women with type 1 diabetes, and achieve TIR of 90% (61).”
From Clinical Targets for Continuous Glucose Monitoring Data Interpretation: Recommendations From the International Consensus on Time in Range (2019) · cites this paper as [61]
The Study Participants section includes only pregnant women with type 1 diabetes. The Results report time in range for those women, while the References list a separate study of type 1 and type 2 glycemic profiles; our copy does not report that women with type 2 diabetes spend one third less time hyperglycemic or achieve 90% time in range. (LLM, conf=0.78)
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- Authors
- Stewart, Z. A., Wilinska, M. E., Hartnell, S., Temple, R. C., Rayman, G., Stanley, K. P., Simmons, D., Law, G. R., Scott, E. M., Hovorka, R., & Murphy, H. R.
- Affiliations
- University of East Anglia (GB)
- ORCID
- Venue
- New England Journal of Medicine
- Publisher
- Massachusetts Medical Society
- Published
- 2016-08-18
- Volume
- 375
- Issue
- 7
- Pages
- 644-654
- ISSN
- 0028-4793 (ISSN-L)
- 1533-4406
- OpenAlex
- W2509567006
- Cited by
- 279
- References
- 29
- Citations by year
- 2026: 16 · 2025: 36 · 2024: 30 · 2023: 32 · 2022: 23 · 2021: 28 · 2020: 21 · 2019: 35 · 2018: 31 · 2017: 22 · 2016: 4
- FWCI
- 30.80
- Type
- journal article
- Language
- en
- Open access
- bronze
- doi.org
- Locations
- New England Journal of Medicine (publishedVersion)
- PubMed (publishedVersion)
- Lincoln Repository (University of Lincoln) (acceptedVersion)
- White Rose Research Online (University of Leeds, The University of Sheffield, University of York) (acceptedVersion)
- UEA Digital Repository (University of East Anglia) (acceptedVersion)
- Figshare (submittedVersion, cc-by)
- Apollo (University of Cambridge) (submittedVersion, cc-by)
- Apollo
- Funders
- Wellcome Trust (100574/Z/12/Z, 100574/B/12/Z)
- National Institute for Health and Care Research (100574/Z/12/Z, PDF/01/036, ACF-2016-14-009, CDF-2013-06-035, 2013-06-035)
- Diabetes UK (07/0003551, BDA 07/0003551)
- University of Cambridge
- Cambridge Trust
- Gates Cambridge Trust
- NIHR Cambridge Biomedical Research Centre (100574/Z/12/Z)
- 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
- artificial pancreas, type 1 diabetes, pregnancy, sensor-augmented pump therapy, glycemic control, hypoglycemia, prenatal care, labor and delivery, continuous glucose monitoring, insulin pump therapy, time in range, insulin dose reduction, neonatal outcomes, maternal outcomes, neonatal hypoglycemia, neonatal hyperbilirubinemia
- MeSH terms
- Adult, Blood Glucose, Diabetes Mellitus, Type 1, Female, Humans, Hypoglycemic Agents, Insulin, Insulin Infusion Systems, Pregnancy, Pregnancy in Diabetics, Cross-Over Studies
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