2-hour 75-g oral glucose tolerance test and Dexcom G6 Pro continuous glucose monitor for Gestational Diabetes

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Gestational Diabetes2-hour 75-g oral glucose tolerance test and Dexcom G6 Pro continuous glucose monitor - DiagnosticTest
Eligibility
18 - 45
Female
What conditions do you have?
Select

Study Summary

This trial is looking at a new way to screen for type 2 diabetes in women who are at high risk. The goal is to improve diagnostic strategies.

Eligible Conditions
  • Gestational Diabetes

Treatment Effectiveness

Study Objectives

0 Primary · 6 Secondary · Reporting Duration: 10 day wear period starting at 0-4 days, 4-6 weeks, and 6 months after delivery

Month 6
Pancreatic beta cell function
Month 6
Maternal and infant body fat composition
Month 6
Maternal glucose variability
Maternal glycemia measured by CGM
Maternal hyperglycemia measured by CGM
Month 6
Maternal diabetes mellitus

Trial Safety

Trial Design

1 Treatment Group

Postpartum GDM
1 of 1

Experimental Treatment

40 Total Participants · 1 Treatment Group

Primary Treatment: 2-hour 75-g oral glucose tolerance test and Dexcom G6 Pro continuous glucose monitor · No Placebo Group · N/A

Postpartum GDM
DiagnosticTest
Experimental Group · 1 Intervention: 2-hour 75-g oral glucose tolerance test and Dexcom G6 Pro continuous glucose monitor · Intervention Types: DiagnosticTest

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: 10 day wear period starting at 0-4 days, 4-6 weeks, and 6 months after delivery

Who is running the clinical trial?

University of Alabama at BirminghamLead Sponsor
1,435 Previous Clinical Trials
2,229,194 Total Patients Enrolled
University of North Carolina, Chapel HillOTHER
1,371 Previous Clinical Trials
3,930,644 Total Patients Enrolled

Eligibility Criteria

Age 18 - 45 · Female Participants · 2 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You are 20 weeks' or less gestational age at the time of diagnosis.
You are a singleton pregnancy at 34-40 weeks gestation.

Who else is applying?

What state do they live in?
North Carolina100.0%
How old are they?
18 - 65100.0%
What site did they apply to?
University of North Carolina at Chapel Hill100.0%
What portion of applicants met pre-screening criteria?
Did not meet criteria100.0%
References