An interventional study of Combines group sessions and CGM-based behavioral feedback in Pre Diabetic and Hyperglycaemia (Non Diabetic), sponsored by Sam Houston State University. Not yet recruiting at 2 sites in United States. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-04-21.
Sponsored by Sam Houston State University · Not applicable, Interventional, and Prevention
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.
793 studies on the registry are indexed under Glucose Intolerance; 115 are open to participants now.
This study's planned enrollment of 20 is below the median of 56 across 661 interventional studies indexed under Glucose Intolerance.
Browse Glucose Intolerance studies →Sam Houston State University is the lead sponsor of 11 studies on the registry; 7 are open to participants now.
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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.
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?
Time frame: 25 weeks
Plan to share: No
This study is not yet recruiting, as verified in Mar 2026. You cannot join it, but the record below documents what was studied.
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Sam Houston State University