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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether continuous glucose monitoring (CGM) can improve health outcomes for mothers and their babies when diagnosing gestational diabetes. It also examines if CGM can lower healthcare costs compared to the usual testing method. Participants will either use CGM or undergo a one-hour glucose tolerance test. This trial targets pregnant individuals between 24-30 weeks of gestation who are being screened for gestational diabetes. As an unphased trial, it offers participants the chance to contribute to innovative research that could enhance future healthcare practices.

Do I have to stop taking my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that Continuous Glucose Monitoring is safe for gestational diabetes?

Research has shown that continuous glucose monitoring (CGM) during pregnancy is generally safe. Studies have found that CGM provides accurate, real-time information about blood sugar levels, aiding in effective management. Pregnant individuals using CGM have found it safe and acceptable. It offers a non-invasive method (meaning it doesn't enter the body) to continuously monitor glucose levels, making it user-friendly. No major negative effects have been widely reported, indicating that CGM is well-tolerated. This makes it a promising tool for managing gestational diabetes. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about Continuous Glucose Monitoring (CGM) for gestational diabetes because it offers a real-time, dynamic way to track glucose levels, unlike traditional methods that rely on periodic testing. This continuous tracking allows for more precise management of blood sugar levels, which can lead to better outcomes for both the mother and baby. Additionally, CGM can provide insights into glucose fluctuations throughout the day and night, offering a more comprehensive picture of glucose control compared to standard glucose tolerance tests.

What evidence suggests that Continuous Glucose Monitoring is effective for gestational diabetes?

Research has shown that Continuous Glucose Monitoring (CGM), a method tested in this trial, can help manage gestational diabetes. CGM provides detailed, real-time information about blood sugar levels, aiding pregnant women in maintaining control. One study found that CGM use, instead of traditional finger-prick tests, lowered hemoglobin A1c levels, a marker for long-term blood sugar control. Another study in pregnant women with gestational and type 2 diabetes demonstrated better blood sugar management with CGM. This trial will compare CGM screening with the one-hour Glucose Tolerance Test (GCT) to evaluate their effectiveness in managing gestational diabetes. CGM may offer a more accurate way to track and manage blood sugar, potentially improving health outcomes for both mothers and their babies. ^{3 4 6 7 8}

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

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12335106/

Continuous glucose monitoring system in diabetes ... A retrospective cohort study evaluating 65 pregnant women with T2D and GDM found that both isCGM and rtCGM improved glycemic control. However, ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12470761/

Exploring Continuous Glucose Monitoring in Gestational ... (4) Conclusions: the CGMS offers a more detailed assessment of both maternal and fetal exposure to high glucose levels, which could lead to ...

3. ajog.org ajog.org/article/S0002-9378(25)00217-0/fulltext

Evidence for improved glucose metrics and perinatal ... Usage of continuous glucose monitoring (vs self-monitoring of blood glucose) reduces hemoglobin A1c and possibly large for gestational age across diabetes in ...

4. sciencedirect.com sciencedirect.com/science/article/pii/S0168822725004036

Continuous glucose monitoring in gestational diabetes ... Advantages of CGM include providing users and healthcare providers with immediate, real-time glucose data, future glucose trajectories with the use of trend ...

5. nejm.org nejm.org/doi/full/10.1056/NEJMoa2205650

Intermittently Scanned Continuous Glucose Monitoring for ... The use of intermittently scanned continuous glucose monitoring with optional alarms for high and low blood glucose levels resulted in significantly lower ...

6. e-enm.org e-enm.org/journal/view.php?number=2600

Advances in Continuous Glucose Monitoring: Clinical ... Studies show that people with diabetes (PwD) using CGM achieve better glycemic outcomes and greater satisfaction with their diabetes management.

7. dom-pubs.onlinelibrary.wiley.com dom-pubs.onlinelibrary.wiley.com/doi/10.1111/dom.15999

Use of continuous glucose monitoring and hybrid closed‐loop ... Real-time CGM (rtCGM) continuously collects glucose data and transmits it every 5 min to a receiver, insulin pump, or smartphone application, ...

8. liebertpub.com liebertpub.com/doi/full/10.1089/dia.2023.0300

Continuous Glucose Monitoring Metrics in High-Risk ... Intermittently scanned CGM (isCGM) has been shown to be acceptable and safe, with seemingly similar efficacy for glucose control during ...