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 — OTHER
    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.

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: SMART
    The 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)

FacilityCityStateZIPSite coordinators
SHSU College of Osteopathic MedicineConroeTexas77304
Svetlana Gezalov
936-202-5279
Damian Chiandussi, MD
936-202-5279
Karen Nelson, PhD (PRINCIPAL_INVESTIGATOR)
SHSU Physician's ClinicConroeTexas77304
Svetlana Gezalov
936-202-5279
Damian Chiandussi, MD
936-202-5279
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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