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

April 15, 2026 updated by: Sam Houston State University

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

The purpose of this study is to evaluate whether combining continuous glucose monitoring (CGM) with group meetings produces improved outcomes in patients with prediabetes. The central hypothesis is 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. Specifically, the research questions are:

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?

It is well known that long-term and personalized lifestyle support reduces T2DM. There is also demonstrated efficiency of continuous glucose monitors (CGM) in diabetic patients. CGMs can provide real-time feedback on lifestyle choices and glycemic responses, acting as a behavior changing tool. This study aims to combine shared medical appointments (SMA) and CGM feedback, focusing on prevention of diabetes.

Prediabetes is alarmingly common and often silent, with 25-50% of individuals with prediabetes progress to type 2 diabetes within 3-10 years. Early intervention makes reversal possible, but most patients receive insufficient guidance or resources.

This study, set in a primary care clinic setting, fills that gap by testing whether pairing SMAs with CGMs enhances patient engagement, lifestyle change, and metabolic outcomes in prediabetes. Benefits will accrue to patients at risk of diabetes (empowerment, better health trajectories), primary care teams (scalable, billable prevention models), and healthcare systems (cost- and outcome-efficient prevention strategies). If successful, this model could reshape early chronic disease management - transforming prediabetes from a silent precursor into an actionable turning point.

Study Type

Interventional

Enrollment (Estimated)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Texas
      • Conroe, Texas, United States, 77304
        • SHSU College of Osteopathic Medicine
        • Contact:
        • Contact:
        • Principal Investigator:
          • Karen Nelson, PhD
      • Conroe, Texas, United States, 77304
        • SHSU Physician's Clinic
        • Contact:
        • Contact:
        • Principal Investigator:
          • Karen Nelson, PhD
        • Sub-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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.
Other: Combines group sessions and CGM-based behavioral feedback

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 study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sam Houston State University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

  • 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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

April 1, 2026

Primary Completion (Estimated)

November 1, 2026

Study Completion (Estimated)

December 1, 2026

Study Registration Dates

First Submitted

April 15, 2026

First Submitted That Met QC Criteria

April 15, 2026

First Posted (Actual)

April 21, 2026

Study Record Updates

Last Update Posted (Actual)

April 21, 2026

Last Update Submitted That Met QC Criteria

April 15, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB-2025-386

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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