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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:
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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Combines group sessions and CGM-based behavioral feedback | Other | The study combines two strategies:
By bringing these two tools together, the research hopes to help participants better understand their own bodies and make lasting lifestyle changes. |
| 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. | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| SHSU College of Osteopathic Medicine | Conroe | Texas | 77304 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Background | 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 |
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| ID | Term |
|---|---|
| D018149 | Glucose Intolerance |
| D006943 | Hyperglycemia |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| SHSU Physician's Clinic | Conroe | Texas | 77304 | United States |
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