Other Clinical Trial - Continuous Glucose Monitor Use in Pregnancy

Status Not yet recruiting

Clinical Trial Summary

The purpose of this study is to perform a randomized controlled trial among 180 pregnant women with type 2 diabetes mellitus (T2DM) comparing continuous glucose monitor (CGM) use to the standard of care of multiple daily fingerstick glucose monitoring and its impact on large for gestational age infants, maternal glycemic control, patient satisfaction, and additional adverse perinatal outcomes.

Clinical Trial Description

A continuous glucose monitor (CGM) can provide detailed insight into daily glucose fluctuations and individual glucose patterns, and it is advised for patients with type 1 diabetes mellitus and advanced type 2 diabetes mellitus (T2DM). Despite this recommendation, pregnant women are not receiving the same standard of care. It has been studied minimally in pregnant women with T2DM, despite preliminary studies showing improvement in adverse perinatal outcomes and glycemic control among pregnant women with type 1 diabetes. Therefore, there is a paucity of data regarding CGM use among pregnant women with T2DM, and significant potential to reduce the significant multigenerational effects associated with diabetes in pregnancy with this technology. The study team therefore propose to perform a randomized controlled trial among 180 pregnant women with T2DM comparing CGM use to the standard of care of multiple daily fingerstick glucose monitoring and its impact on large for gestational age infants, maternal glycemic control, patient satisfaction, and additional adverse perinatal outcomes. ;

Study Design

Related Conditions & MeSH terms

Diabetes Mellitus, Type 2
Pregnancy, High Risk
Type 2 Diabetes Treated With Insulin

Clinical Trial Details

NCT number	NCT05317585
Study type	Interventional
Source	University of Massachusetts, Worcester
Contact	Gianna L Wilkie, MD
Phone	7743642523
Email	Gianna.Wilkie@umassmemorial.org
Status	Not yet recruiting
Phase	N/A
Start date	October 1, 2024
Completion date	July 1, 2027

View Details

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