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Provider Perspective on Automated Insulin Devices in Pregnancy and Considerations for Implementation in Clinical
1Division of Endocrinology, Diabetes, and Metabolism, Icahn School of Medicine at Mount Sinai, New York, NY, USA.
Journal of Diabetes Science and Technology
|May 8, 2025
Summary
Hybrid closed-loop (HCL) and advanced hybrid closed-loop (AHCL) systems show promise for managing type 1 diabetes mellitus (T1D) during pregnancy. Further research is needed to optimize their use and address regulatory gaps for improved maternal and neonatal outcomes.
Area of Science:
- Endocrinology
- Maternal-Fetal Medicine
- Diabetes Technology
Background:
- Pregnancy in type 1 diabetes mellitus (T1D) is associated with poor maternal and neonatal outcomes.
- Advancements in diabetes technology, including hybrid closed-loop (HCL) and advanced hybrid closed-loop (AHCL) systems, have improved T1D management.
- Pregnant individuals with T1D remain a high-risk group requiring further investigation, especially regarding advanced diabetes management systems.
Purpose of the Study:
- To review existing evidence on the use of closed-loop systems in pregnancies complicated by T1D.
- To discuss the implications and considerations for using HCL/AHCL systems during pregnancy.
- To highlight the current regulatory landscape and off-label use of these systems in different regions.
Main Methods:
- Literature review of studies evaluating closed-loop systems in pregnant individuals with T1D.
- Analysis of data on glycemic control, maternal, and neonatal outcomes.
- Discussion of system-specific benefits, limitations, and assistive techniques required for pregnancy.
Main Results:
- Existing trials show mixed results regarding the clinical benefits of closed-loop systems for glycemic control in pregnancy.
- One AHCL system is approved in the UK, Europe, and Australia, but no FDA-approved systems exist for pregnancy in the US.
- Off-label use in the US often necessitates additional strategies to achieve target glucose levels.
Conclusions:
- Closed-loop systems, including HCL/AHCL, may reduce the burden of care for pregnant individuals with T1D compared to multiple daily injections or sensor-augmented pump therapy.
- These systems can potentially help achieve tighter glucose control, which is crucial during pregnancy.
- Further research and regulatory approvals are essential to facilitate the safe and effective use of closed-loop systems in T1D pregnancies.
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