Pre DiabeticCGMNCT07543068
Diabetes Prevention by Group Intervention and CGM Use in Pre-diabetic Adults
A study testing Combines group sessions and CGM-based behavioral feedback in people with Pre Diabetic and Hyperglycaemia (Non Diabetic), run by Sam Houston State University at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Pre Diabetic, Hyperglycaemia (Non Diabetic)
- What is being tested?
- Combines group sessions and CGM-based behavioral feedback
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 2 sitesUnited States
- Study dates
- Apr 2026to Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites
SHSU College of Osteopathic Medicine
Conroe, Texas, 77304
Svetlana Gezalov, 936-202-5279, sxg233@shsu.edu
Damian Chiandussi, MD, 936-202-5279, dac150@shsu.edu
SHSU Physician's Clinic
Conroe, Texas, 77304
Svetlana Gezalov, 936-202-5279, sxg233@shsu.edu
Damian Chiandussi, MD, 936-202-5279, dac150@shsu.edu
About this study
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:
Read more
- Group visits - small, regular meetings where patients learn about healthy eating, physical activity, and stress management.
- 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.
Read the 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.
- Conditions
- Pre Diabetic, Hyperglycaemia (Non Diabetic)
- Being tested
- Combines group sessions and CGM-based behavioral feedback
- Keywords
- CGM, Pre Diabetes, Elevated sugar, Hyperglycemia, Hyperglycaemia, Interventions
- Medical subject headings
- Glucose Intolerance, Hyperglycemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Combines group sessions and CGM-based behavioral feedbackOther
The study combines two strategies:
- Group visits - small, regular meetings where patients learn about healthy eating, physical activity, and stress management.
- 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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Combines group sessions and CGM-based behavioral feedback |
What is being measured
The primary outcome is the main question the study is designed to answer.
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?
Measured: 25 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Apr 2026
- Study startApr 2026 (estimated)
- Primary completionNov 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Pre DiabeticStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sam Houston State University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07543068
- Sponsor's protocol ID
- IRB-2025-386
- Acronym
- CGM
- Status last verified
- Mar 2026
- First submitted
- 15 Apr 2026
- Last updated
- 21 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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 at a glance
From the registry record, last updated by the sponsor on 21 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diabetes Prevention by Group Intervention and CGM Use in Pre-diabetic Adults
- ClinicalTrials.gov ID
- NCT07543068
- Acronym / sponsor ID
- CGM / IRB-2025-386
- Conditions
- Pre Diabetic, Hyperglycaemia (Non Diabetic)
- Keywords
- CGM, Pre Diabetes, Elevated sugar, Hyperglycemia, Hyperglycaemia, Interventions
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Sam Houston State UniversityUniversity, hospital or other
- Study start
- Apr 2026 (estimated)
- Primary completion
- Nov 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 21 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Group visits - small, regular meetings where patients learn about healthy eating, physical activity, and stress management.
- 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.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| SMART | Experimental | Other: Combines group sessions and CGM-based behavioral feedbackThe 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. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (6 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Combines group sessions and CGM-based behavioral feedbackThe 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. | Other | SMART |
Primary outcome
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?
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Apr 2026.
- Background1. 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
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Combines group sessions and CGM-based behavioral feedback in people with Pre Diabetic and Hyperglycaemia (Non Diabetic), run by Sam Houston State University at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 21 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07543068, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Apr 2026.