Diabetes Prevention by Group Intervention and CGM Use in Pre-diabetic Adults
Part of paid clinical trials in Conroe, Texas.
- Sponsor
- Sam Houston State University
- Study ID
- NCT07543068
- Status
- Not Yet Recruiting
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Conditions
- Hyperglycaemia (Non Diabetic)
- Pre Diabetic
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - 75 Years
- Healthy Volunteers
- Not accepted
Interventions
- Combines group sessions and CGM-based behavioral feedback — OTHERThe 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.
Study Details
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.
Key Dates
- Start date
- Apr 30, 2026
- Status verified
- Mar 2026
- Primary completion
- Nov 30, 2026
- Completion
- Dec 31, 2026
Study Design
- Enrollment
- 20 participants (estimated)
- Allocation
- NA
- Intervention model
- SINGLE_GROUP
- Primary purpose
- PREVENTION
Arms
- Experimental: SMARTThe intervention combines group sessions and CGM-based behavioral feedback. Group sessions will occur twice in month 1 and monthly thereafter at the SHSU clinic and will cover nutrition, movement, stress, sleep and habit formation. Study investigators will prepare and coordinate each meeting; additional presenters include a nutritionist, an exercise specialist (activity planning), and a behavioral health clinician. Participants will be using CGMs during the weeks 3-6 and 13-14 or 13-16.
Primary Outcome Measure
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. [ Time Frame: 25 weeks ]
Locations (2)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| SHSU College of Osteopathic Medicine | Conroe | Texas | 77304 | Karen Nelson, PhD (PRINCIPAL_INVESTIGATOR) |
| SHSU Physician's Clinic | Conroe | Texas | 77304 | Karen Nelson, PhD (PRINCIPAL_INVESTIGATOR) Svetlana Gezalov (SUB_INVESTIGATOR) Lauren Fell (SUB_INVESTIGATOR) Abigail Dorow (SUB_INVESTIGATOR) Priscila Martinez Avila (SUB_INVESTIGATOR) Stephanie Potter, DO (SUB_INVESTIGATOR) Damian Chiandussi, MD (SUB_INVESTIGATOR) |
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