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 trial aims to help individuals with prediabetes prevent or delay type 2 diabetes by combining two approaches: group visits and continuous glucose monitors (CGMs). Group visits offer support and education on healthy eating, exercise, and stress management. CGMs, wearable devices, track blood sugar levels in real-time, illustrating how lifestyle choices impact the body. The study seeks participants diagnosed with prediabetes who can attend group meetings in Conroe, TX, and are comfortable using CGM devices. As an unphased trial, this study provides a unique opportunity to actively engage in innovative research that could enhance health and well-being.

Will I have to stop taking my current medications?

If you are currently taking glucose-lowering medications like GLP-1 or Metformin, you cannot participate in this trial. The protocol does not specify about other medications, so it's best to discuss with the trial team.

What prior data suggests that this combination of group sessions and CGM is safe for prediabetes management?

Research has shown that Continuous Glucose Monitors (CGMs) are generally safe for individuals with prediabetes. Studies have found that CGM devices help users manage blood sugar more effectively without major side effects. For instance, one study found that CGM users felt more confident in managing their condition and improved their health habits.

Another study noted increased activity levels among CGM users, with no reported negative effects. Overall, most people find CGMs easy to use, and they can help prevent type 2 diabetes. Group sessions focusing on healthy eating and lifestyle changes are also safe and beneficial for health improvement.12345

Why are researchers excited about this trial?

Unlike standard treatments for prediabetes, which often rely solely on medication and lifestyle advice, this innovative approach combines group sessions with real-time feedback using Continuous Glucose Monitoring (CGM). Researchers are excited about this treatment because it offers personalized insights into how diet, exercise, stress, and sleep affect blood sugar levels, empowering participants to make informed lifestyle changes. The integration of group support and expert guidance from nutritionists, exercise specialists, and behavioral health clinicians enhances motivation and accountability, potentially leading to more sustainable health improvements.

What evidence suggests that combining group sessions and CGM is effective for prediabetes?

Research has shown that using Continuous Glucose Monitors (CGMs) along with group sessions can benefit people with prediabetes. In this trial, participants will receive a combination of group sessions and CGM-based behavioral feedback. CGMs track blood sugar levels in real-time, allowing individuals to see how their eating and activity affect their bodies. This understanding can lead to better blood sugar control. For instance, one study found that using a CGM led to a noticeable drop in HbA1c, which measures average blood sugar levels, by about 0.4%. Group sessions provide support and teach healthy habits, further improving results. Together, these tools encourage healthier lifestyles and help prevent the development of type 2 diabetes.15678

Are You a Good Fit for This Trial?

This trial is for adults aged 18-75 who have been diagnosed with prediabetes but do not yet have diabetes. Participants must speak English, not be on diabetes medications, not be pregnant, and must be able to attend group meetings in Conroe, TX and use a wearable glucose monitor.

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.
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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

Trial Overview

The study tests whether combining regular group sessions about healthy habits with the use of continuous glucose monitors (CGMs) helps people with prediabetes lower their blood sugar and feel more confident managing their health.

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+

Citations

Behavior Modification in Prediabetes and Diabetes: Potential ...

Our study showed that intermediate use of RT-CGM serially over 3 months improved HbA1c by average of 1.0% in subjects with T2D on no prandial ...

Diabetes Prevention by Group Intervention and CGM Use ...

The purpose of this study is to evaluate whether combining continuous glucose monitoring (CGM) with group meetings produces improved outcomes in ...

Impact of real-time continuous glucose monitoring and ...

Real-time CGM with digital coaching improved glycemic control in T2DM and prediabetes. · High glycemic variability group showed the greatest HbA1c reduction ...

Impact of Continuous Glucose Monitoring–Guided ...

Objectives: To evaluate the effectiveness of CGM-guided behavioral interventions on preventing progression to T2DM and improving metabolic ...

Does CGM feedback change behavior outside of diabetes ...

Randomized controlled trials show CGM with behavior-change apps drives significant weight loss, improved HbA1c, reduced added sugar intake, and ...

The Impact of Self-Regulation Education Combined ... - PMC

Results: The CGM group demonstrated consistent diabetes self-efficacy, significant improvements in diabetes health behaviors, and a reduction in ...

The Effects of Continuous Glucose Monitoring on Patient ...

CGM participants exhibited a greater reduction in total PAID scores at 12 weeks vs baseline when compared with those not using CGM (p=0.03), with similar ...

Group Intervention + CGM for Prediabetes (CGM Trial)

This study is being done to find better ways to help people with prediabetes prevent or delay the development of type 2 diabetes.