Glucose Tolerance Test + Continuous Glucose Monitoring for Postpartum High Blood Sugar

Recruiting at1 trial location

Age: 18 - 65

Sex: Female

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: University of Alabama at Birmingham

No Placebo Group

Trial Summary

What is the purpose of this trial?

This trial uses a device to track blood sugar levels in women who had diabetes during pregnancy. These women are at high risk for developing type 2 diabetes later. The study aims to understand their blood sugar patterns after childbirth and improve screening methods for diabetes.

Research Team

Eligibility Criteria

This trial is for women who had gestational diabetes during a single pregnancy with no fetal anomalies, diagnosed before 20 weeks or at/after 24 weeks and required medication. It's not for those with skin conditions affecting glucose monitor use, history of prediabetes, PCOS, or pregestational type 2 diabetes.

Inclusion Criteria

I was diagnosed with gestational diabetes before 20 weeks of pregnancy and needed medication.

I was diagnosed with gestational diabetes needing medication after 24 weeks of pregnancy.

I am 34-40 weeks pregnant with one healthy baby.

Exclusion Criteria

I cannot wear a glucose monitor due to skin conditions.

I have had type 2 diabetes before becoming pregnant.

I have a history of prediabetes or polycystic ovarian syndrome.

Treatment Details

Interventions

• 2-hour 75-g oral glucose tolerance test (Diagnostic Test)
• Dexcom G6 Pro continuous glucose monitor (Diagnostic Test)

Trial Overview The study tests how well two methods can track blood sugar levels after childbirth in women at risk for long-term high blood sugar. One method is a standard oral glucose tolerance test; the other uses a Dexcom G6 Pro continuous glucose monitor.

Participant Groups

Group I: Postpartum GDM Experimental Treatment 1 Intervention

Women with GDM diagnosed early (\< 20 weeks gestation) or with routine 3rd trimester screening (\>=24 weeks) will be enrolled in this longitudinal study. All enrolled women will complete a oral glucose tolerance test and wear a continuous glucose monitor for 10 days at the 3 designated study time points (0-4 days, 4-6 weeks, and 6 months after delivery).

Who Is Running the Clinical Trial?

University of Alabama at Birmingham

Lead Sponsor

Trials

1,677

Recruited

2,458,000+

Kierstin Kennedy

University of Alabama at Birmingham

Chief Medical Officer since 2022

MD

S. Dawn Bulgarella

University of Alabama at Birmingham

Chief Executive Officer since 2023

BSc in Commerce and Business Administration from the University of Alabama, MS in Health Administration from the University of Alabama at Birmingham

University of North Carolina, Chapel Hill

Collaborator

Trials

1,588

Recruited

4,364,000+

Dr. Peggy P. McNaull

University of North Carolina, Chapel Hill

Chief Medical Officer

MD from Louisiana State University School of Medicine

Dr. Lynne Fiscus

University of North Carolina, Chapel Hill

Chief Executive Officer since 2020

MD from Georgetown University, MPH from UNC