Ignite Creation Date:
2025-12-24 @ 12:20 PM
Ignite Modification Date:
2025-12-24 @ 12:20 PM
Study NCT ID:
NCT05714761
Status:
COMPLETED
Last Update Posted:
2025-03-20
First Post:
2023-01-27
Is Possible Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Postpartum Continuous Glucose Monitoring (CGM) Study
Sponsor:
Icahn School of Medicine at Mount Sinai
Organization:
Study Overview
Official Title:
Postpartum Dysglycemia Screening With Continuous Glucose Monitoring
Status:
COMPLETED
Status Verified Date:
2025-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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).
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: