Continuous Glucose Monitoring for Gestational Diabetes

Overseen By Sarah Nazeer

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: The University of Texas Health Science Center, Houston

Disqualifiers: Type I and II DM, Bariatric surgery, Major fetal anomalies, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 5 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 1

Duration: From enrollment to delivery

816 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

The purpose of this study is to evaluate whether Continuous glucose monitoring (CGM) for diagnosis of gestational diabetes mellitus (GDM) improves maternal and neonatal outcomes related to GDM and to evaluate whether CGM for GDM diagnosis reduces the health system costs for mother-infant dyads compared to usual care

Who Is on the Research Team?

Michal Fishel Bartal, MD

Principal Investigator

The University of Texas Health Science Center, Houston

Are You a Good Fit for This Trial?

This trial is for pregnant women between 24-30 weeks gestation who are being screened for gestational diabetes. It's not open to those with a known diagnosis of Type I or II diabetes, history of bariatric surgery, major fetal anomalies, or allergies to CGM components.

Inclusion Criteria

Pregnant individuals between 24 to 30 weeks of pregnancy getting checked for gestational diabetes.

Exclusion Criteria

You do not want to use continuous glucose monitoring for screening gestational diabetes.

I have had weight loss surgery in the past.

I have been diagnosed with Type 1 or Type 2 diabetes.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Treatment

Participants undergo continuous glucose monitoring (CGM) for diagnosis of gestational diabetes mellitus (GDM) to improve maternal and neonatal outcomes

From enrollment to delivery

Regular monitoring visits

Follow-up

Participants are monitored for safety and effectiveness after treatment, including evaluation of neonatal outcomes and maternal health

Up to 6 months postpartum

Multiple visits (in-person and virtual)

What Are the Treatments Tested in This Trial?

Interventions

• CGM

Trial Overview The study compares two methods: Group 1 will undergo the standard one-hour Glucose Challenge Test (GCT), while Group 2 will use Continuous Glucose Monitoring (CGM) devices. The goal is to see if CGM can improve outcomes and reduce healthcare costs.

How Is the Trial Designed?

Group I: CGM screening Experimental Treatment 1 Intervention

Group II: one-hour Glucose tolerance test (GCT) Active Control 1 Intervention

CGM is already approved in European Union, United States, Canada, Japan for the following indications:

Approved in European Union as Continuous Glucose Monitoring for:

• Type 1 diabetes
• Type 2 diabetes

Approved in United States as Continuous Glucose Monitoring for:

• Type 1 diabetes
• Type 2 diabetes

Approved in Canada as Continuous Glucose Monitoring for:

• Type 1 diabetes
• Type 2 diabetes

Approved in Japan as Continuous Glucose Monitoring for:

• Type 1 diabetes
• Type 2 diabetes

Who Is Running the Clinical Trial?

The University of Texas Health Science Center, Houston

Lead Sponsor

Trials

974

Recruited

361,000+

DexCom, Inc.

Industry Sponsor

Trials

151

Recruited

35,700+

Kevin Sayer

DexCom, Inc.

Chief Executive Officer since 2015

Bachelor’s and Master’s degrees in Accounting and Information Systems from Brigham Young University

Dr. Shelly Lane

DexCom, Inc.

Chief Medical Officer since 2023

MD from University of California, San Diego