Postpartum Continuous Glucose Monitoring (CGM) Study

Mount Sinai Health System

Status

Completed

Conditions

Gestational Diabetes

Treatments

Device: Dexcom glucose sensor

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT05714761

STUDY-20-02062

Details and patient eligibility

About

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).

Enrollment

50 patients

Sex

Female

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

include diagnosis of gestational diabetes during a current or recent pregnancy
age 18 or older.

Exclusion criteria

include known pregestational diabetes,
known skin adhesive allergy which would prevent subject from wearing a CGM,
chronic glucocorticoid use which is planned to be ongoing after labor and delivery discharge.