Group Intervention + CGM for Prediabetes

(CGM Trial)

Not yet recruiting at 1 trial location
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This study is being done to find better ways to help people with prediabetes prevent or delay the development of type 2 diabetes. Prediabetes means your blood sugar is higher than normal, but not high enough to be diagnosed with diabetes. It is often silent, but without changes in diet and activity, many people progress to a diagnosis of diabetes within a few years.

The study combines two strategies:

1. Group visits - small, regular meetings where patients learn about healthy eating, physical activity, and stress management.

2. Continuous Glucose Monitors (CGMs) - small wearable sensors that measure blood sugar all day and show how food, movement, and sleep affect it in real time.

By bringing these two tools together, the research hopes to help participants better understand their own bodies and make lasting lifestyle changes.

What is the purpose of this research?

The purpose of this research is to find out whether using a CGM device together with group sessions can help people with prediabetes lower their average blood sugar (measured by A1C) and improve confidence in managing their health.

Are You a Good Fit for This Trial?

Inclusion Criteria

Diagnosed with Prediabetes by a physician based on A1c, fasting glucose or American Diabetes Association (ADA) Type 2 risk test
I am between 18 and 75 years old.

Exclusion Criteria

Non-English-Speaking individuals
I am taking medication to lower my blood sugar.
I have been diagnosed with diabetes.
See 3 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants engage in group sessions and use CGMs for behavioral feedback. Group sessions occur twice in month 1 and monthly thereafter, covering nutrition, movement, stress, sleep, and habit formation.

25 weeks
2 visits in month 1, monthly visits thereafter

CGM Monitoring

Participants use CGMs during weeks 3-6 and 13-14 or 13-16 to receive real-time feedback on lifestyle choices and glycemic responses.

4 weeks (weeks 3-6) and 1-3 weeks (weeks 13-14 or 13-16)

Follow-up

Participants are monitored for improvements in clinical outcomes such as fasting glucose, HbA1c, and weight compared to baseline measures.

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Combines group sessions and CGM-based behavioral feedback

How Is the Trial Designed?

1

Treatment groups

Experimental Treatment

Group I: SMARTExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Sam Houston State University

Lead Sponsor

Trials
6
Recruited
1,200+