NCT05714761

Postpartum Continuous Glucose Monitoring (CGM) Study

Postpartum Dysglycemia Screening With Continuous Glucose Monitoring

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 50 (actual)
• Sponsor: Icahn School of Medicine at Mount Sinai · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This research study is being done to assess if using a glucose sensor (also known as a continuous glucose monitor) after childbirth can help identify women who are at risk of developing diabetes after having diabetes during pregnancy or gestational diabetes. Currently, screening for diabetes after childbirth is performed with an oral glucose tolerance test 6-12 weeks after delivery, but this is burdensome. This study will use a glucose sensor worn on the skin for 10 days. The data from the sensor will be compared to the standard oral glucose tolerance test. This is a single site study at the Icahn School of Medicine at Mount Sinai. The research team plans to enroll 50 participants aged 18years or older into the study. Participation in the study is expected to last up to 20 weeks and involves 4-5 visits depending on if enrollment is in the 3rd trimester of pregnancy or immediate postpartum. Study procedures include 1. Consent \& screening. 2.Sensor placement and download after 10 days of wear. 3. a second sensor placement 2-5 days before oral glucose tolerance test (OGTT).

Conditions

• Gestational Diabetes

Interventions

Type	Name	Description
DEVICE	Dexcom glucose sensor	Use of a Dexcom G6 Pro

Timeline

• Start date: 2023-02-16
• Primary completion: 2024-03-08
• Completion: 2024-03-08
• First posted: 2023-02-06
• Last updated: 2025-03-20
• Results posted: 2025-03-20

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study