Diabetes Prevention by Group Intervention and CGM Use in Pre-diabetic Adults
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-75
SponsorSam Houston State University
About 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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Diagnosed with Prediabetes by a physician based on A1c, fasting glucose or American Diabetes Association (ADA) Type 2 risk test.
18 to 75 years old inclusive.
Disqualifiers
Non-English-Speaking individuals.
Diagnosed with Diabetes.
Use of glucose lowering medications (GLP-1, Metformin, etc.)
Pregnant women.
Trial design
Design model
Single group
Treatments tested in this trial
Combines group sessions and CGM-based behavioral feedback
Other interventionThe 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.
Treatment groups
20 Participants
are divided into 1 treatment groupGroup A: SMARTExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
That pairing real-time physiologic feedback from CGMs with the structured curriculum, peer accountability, and multidisciplinary support will facilitate meaningful lifestyle changes and better metabolic control in this population.
Among patients with prediabetes, does participation in a program that integrates CGMs with group meetings lead to improvements in clinical outcomes such as fasting glucose, HbA1c, and weight compared to baseline measures? Does the combined use of CGMs and SMAs enhance psychosocial outcomes such as self-efficacy, readiness to change, and adherence to lifestyle modifications in patients with prediabetes? Does the integration of CGMs into lifestyle change program increase participant engagement and attendance compared to program alone?
Time frame
25 weeksSponsors and contacts
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Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: