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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.
Abstract:
Pregnancy in people with type 1 diabetes mellitus (T1D) is well-known to be linked to adverse maternal and neonatal outcomes. Although advancements in diabetes technology, especially hybrid closed-loop (HCL) and advanced hybrid closed-loop (AHCL) systems, have greatly enhanced management for nonpregnant individuals with T1D, pregnant patients still represent a high-risk group that requires further research. Existing trials have shown mixed data in terms of clinically meaningful benefits in glycemic control, but these may be specific to the closed-loop system. Currently, there is one AHCL system approved and available for use in pregnancies complicated by diabetes in the United Kingdom, Europe, and Australia. However, there are no Food and Drug Administration (FDA)-approved closed-loop systems for use during pregnancy in the United States. Existing HCL/AHCL system use is off-label for pregnancy in the United States and often requires assistive techniques to target the tighter glucose levels needed during pregnancy. For patients struggling on multiple daily injections (MDIs) or sensor-augmented pump therapy (SAPT), studies have shown that HCL/AHCLs can reduce the burden of care and enable some people to achieve tighter glucose levels. This review aims to provide an overview of the existing evidence of closed-loop systems in pregnancies complicated by T1D and to discuss their implications and considerations with system use.
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