Postpartum Continuous Glucose Monitoring (CGM) Study

Gestational Diabetes Clinical Trial

Official title:

Postpartum Dysglycemia Screening With Continuous Glucose Monitoring

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05714761
• Other study ID #: STUDY-20-02062
• Status: Completed
• Phase: N/A
• Start date: February 16, 2023
• Est. completion date: March 11, 2024

Study information

• Verified date: May 2024
• Source: Icahn School of Medicine at Mount Sinai
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: March 11, 2024
• Est. primary completion date: February 3, 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Diabetes, Gestational
• Gestational Diabetes

Intervention

Device:
• Dexcom glucose sensor
Use of a Dexcom G6 Pro

Locations

Country	Name	City	State
United States	Icahn School of Medicine at Mount Sinai	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Icahn School of Medicine at Mount Sinai

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of participants with at least 72 hours of CGM data downloaded.	Percentage of participants with at least 72 hours of CGM data downloaded.	End of study, at 12 months
Secondary	Specificity	Specificity for CGM compared to oral glucose tolerance test for diagnosis of diabetes, impaired glucose tolerance and impaired fasting glucose. The specificity of a test is the proportion of people who test negative among all those who actually do not have that disease.	End of study, at 12 months
Secondary	Sensitivity	Sensitivity for CGM compared to oral glucose tolerance test for diagnosis of diabetes, impaired glucose tolerance and impaired fasting glucose. The sensitivity of a test is the proportion of people who test positive among all those who actually have the disease.	End of study, at 12 months
Secondary	Positive predictive value (PPV)	PPV for CGM compared to oral glucose tolerance test for diagnosis of diabetes, impaired glucose tolerance and impaired fasting glucose. Positive predictive value is the probability that following a positive test result, that individual will truly have that specific disease.	End of study, at 12 months
Secondary	Negative predictive value (NPV)	NPV for CGM compared to oral glucose tolerance test for diagnosis of diabetes, impaired glucose tolerance and impaired fasting glucose. Negative predictive value is the probability that following a negative test result, that individual will truly not have that specific disease.	End of study, at 12 months