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

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

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07543068
Acronym
CGM
Enrollment
20
Registered
2026-04-21
Start date
2026-04-01
Completion date
2026-12-01
Last updated
2026-04-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hyperglycaemia (Non Diabetic), Pre Diabetic

Keywords

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

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. 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.

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.

Interventions

OTHERCombines 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.

Sponsors

Sam Houston State University
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
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.25 weeksAmong 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?

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 22, 2026