NCT05317585

Continuous Glucose Monitor Use in Pregnancy

Continuous Glucose Monitor Use and Perinatal Outcomes Among Pregnant Women With Type 2 Diabetes Mellitus: A Randomized Controlled Trial

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 180 (estimated)
• Sponsor: University of Massachusetts, Worcester · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

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

Interventions

Type	Name	Description
DEVICE	Continuous Glucose Monitor	Continuous Glucose Monitor
DEVICE	Routine Capillary Blood Glucose Monitoring (Fingerstick Glucose)	Routine Capillary Blood Glucose Monitoring (Fingerstick Glucose)

Timeline

• Start date: 2024-05-23
• Primary completion: 2026-07-01
• Completion: 2027-07-01
• First posted: 2022-04-08
• Last updated: 2025-10-01

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study