Diabetes Prevention by Group Intervention and CGM Use in Pre-diabetic Adults

NCT07543068 | Not Yet Recruiting

• 1 other identifier: IRB-2025-386
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 2

Brief Summary

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. 1.Group visits - small, regular meetings where patients learn about healthy eating, physical activity, and stress management.
2. 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.

Conditions

Pre Diabetic; Hyperglycaemia (Non Diabetic)

Keywords

CGM; Pre Diabetes; Elevated sugar; Hyperglycemia; Hyperglycaemia; Interventions

Outcome Measures

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?

  25 weeks

Study Arms (1)

SMART

EXPERIMENTAL

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.

Other: Combines group sessions and CGM-based behavioral feedback

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.

SMART

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosed with Prediabetes by a physician based on A1c, fasting glucose or American Diabetes Association (ADA) Type 2 risk test.
• to 75 years old inclusive.

You may not qualify if:

• Non-English-Speaking individuals.
• Diagnosed with Diabetes.
• Use of glucose lowering medications (GLP-1, Metformin, etc.)
• Pregnant women.
• Unwilling to use Continuous Glucose Monitors (CGMs)
• Unable to assist to the Group meetings in Conroe, TX.

Sponsors & Collaborators

• Sam Houston State University: lead

Study Sites (2)

SHSU College of Osteopathic Medicine

Conroe, Texas, 77304, United States

Location

SHSU Physician's Clinic

Conroe, Texas, 77304, United States

Location

Related Publications (1)

• 1. Richardson, K. M., Schembre, S. M., da Silva, V., Blew, R. M., Behrens, N., Roe, D. J., Marvasti, F. F., & Hingle, M. (2024). Adding a Brief Continuous Glucose Monitoring Intervention to the National Diabetes Prevention Program: A Multimethod Feasibility Study. Journal of diabetes research, 2024, 7687694. https://doi.org/10.1155/2024/7687694 2. Zahalka, S. J., Akturk, H. K., Galindo, R. J., Shah, V. N., & Low Wang, C. C. (2025). Continuous Glucose Monitoring for Prediabetes: Roles, Evidence, and Gaps. Endocrine practice: official journal of the American College of Endocrinology and the American Association of Clinical Endocrinologists, 31(8), 1054-1060. https://doi.org/10.1016/j.eprac.2025.05.742 3. Ahn, Y. C., Kim, Y. S., Kim, B., Ryu, J. M., Kim, M. S., Kang, M., & Park, J. (2023). Effectiveness of Non-Contact Dietary Coaching in Adults with Diabetes or Prediabetes Using a Continuous Glucose Monitoring Device: A Randomized Controlled Trial. Healthcare (Basel, Switzerland), 11(2), 252. https://doi.org/10.3390/healthcare11020252 4. Portal Teixeira, P., Pozzer Zucatti, K., Strassburger Matzenbacher, L., Fink Wayerbacher, L., Zhang, M., Colpani, V., & Gerchman, F. (2024). Long-term lifestyle intervention can reduce the development of type 2 diabetes mellitus in subjects with prediabetes: A systematic review and meta-analysis. Diabetes research and clinical practice, 210, 111637. https://doi.org/10.1016/j.diabres.2024.111637

  BACKGROUND

MeSH Terms

Conditions

Glucose Intolerance; Hyperglycemia

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 15, 2026
• First Posted: April 21, 2026
• Study Start: April 1, 2026
• Primary Completion (Estimated): November 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: April 21, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)