PreDiabetesCGM-DPPNCT07140848
CGM-Enhanced DPP to Prevent Type 2 Diabetes in Adults With Prediabetes
A study testing CGM-DPP in people with PreDiabetes, run by State University of New York at Buffalo at 1 site in United States.
Trial summary
Prediabetes affects over one-third of adults in the United States, placing them at a higher risk for developing type 2 diabetes and heart disease, which can lead to serious health complications and increased medical costs. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- PreDiabetes
- What is being tested?
- CGM-DPP
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 13 Apr 2026to Mar 2028
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- adults aged 18 years or older,
- diagnosis of prediabetes, as defined by current clinical guidelines (HbA1c 5.7% to 6.4%, fasting plasma glucose 100-125 mg/dL, or 2-hour plasma glucose 140-199 mg/dL following a 75g oral glucose tolerance test),
- body mass index (BMI) of at least 24 kg/m² (or 22 kg/m² for Asian Americans),
- willingness to comply with all aspects of the study protocol, including attending coaching sessions and using CGM devices.
Who cannot join
- Individuals will be excluded from the study if they
- have a diagnosis of type 1 or type 2 diabetes,
- are currently using CGMs or have medical contraindications to CGM use, such as severe skin allergies or implantable defibrillators, or
- are currently enrolled in another clinical trial for prediabetes. Additionally, using validated assessments, we will exclude participants with significant dementia, alcohol or drug abuse/dependency, active psychosis, or life expectancy less than 12 months as these conditions are likely to interfere with adherence to the intervention.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Division of Population Health, Department of Medicine
Buffalo, New York, 14203
Jennifer A Campbell, PhD, MPH, 716-829-5767, jcampbe@buffalo.edu
About this study
Official title: A Novel Continuous Glucose Monitoring Enhanced DPP Intervention to Prevent Type 2 Diabetes in Adults With Prediabetes
Prediabetes affects over one-third of adults in the United States, placing them at a higher risk for developing type 2 diabetes and heart disease, which can lead to serious health complications and increased medical costs. Although a program called the Diabetes Prevention Program (DPP) has been shown to lower the risk of diabetes through healthy lifestyle changes, many people find it difficult to stick with these changes over the long term. This study seeks to find out if combining DPP coaching with continuous glucose monitoring (CGM) technology can help people stay on track with their health goals.
Read the detailed description
CGM devices give individuals real-time information about their blood sugar levels, which can help them understand how their diet, exercise, and daily habits impact their health. By pairing CGM technology with support from trained DPP coaches, this approach aims to make it easier for participants to maintain healthy behaviors. The study will involve 214 adults with prediabetes who will follow a 12-month program with regular check-ins to measure improvements in blood sugar control, weight loss, physical activity, and overall quality of life.
The goal is to show whether using CGM in combination with coaching can lead to better health outcomes and whether it is a cost-effective way to prevent diabetes. If successful, this approach could be used in healthcare settings across the country, helping more people prevent diabetes and lead healthier lives.
- Conditions
- PreDiabetes
- Being tested
- CGM-DPP, Control
- Medical subject headings
- Prediabetic State
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CGM-DPPBehavioural
Participants in the DPP who receive personalized CGM coaching.
ControlBehavioural
Participants in control group will be referred to DPP.
| Study group | Role | What they receive |
|---|---|---|
| Control | Active comparator | Diabetes Prevention Program Receives: Behavioral: Control |
| Intervention | Experimental | Diabetes Prevention Program + Continuous Glucose Monitors/Coaching Receives: Behavioral: CGM-DPP |
What is being measured
The primary outcome is the main question the study is designed to answer.
Glycemic Control (HbA1c)
Blood specimens (10 cc of blood) will be obtain by trained phlebotomists or nurse for HbA1c.
Measured: Change from baseline HbA1c at 12 months post intervention follow-ups
Secondary outcomes (1)
Quality of Life as measured by SF-12
The SF-12 (Ware 1996) is a valid and reliable instrument to measure functional status and reproduces 90% of the variance in PCS-36 and MCS-36 scores.
Measured: Change from baseline quality of life measure at 12 months post intervention follow-ups
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2025
- Study start13 Apr 2026
- Primary completionMar 2028 (estimated)
- Study completionMar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PreDiabetesStudies of the same condition, open and under way.
- More trials run by State University of New York at BuffaloThe sponsor's other registered studies.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- State University of New York at Buffalo
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Raphael Fraser, PhD, State University of New York at Buffalo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07140848
- Sponsor's protocol ID
- STUDY00009767
- Other IDs
- ADA Grant #7-25-ICTSPC-412
- Acronym
- CGM-DPP
- Status last verified
- Oct 2026
- First submitted
- 22 Aug 2025
- Last updated
- 3 Nov 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Novel Continuous Glucose Monitoring Enhanced DPP Intervention to Prevent Type 2 Diabetes in Adults With Prediabetes
- ClinicalTrials.gov ID
- NCT07140848
- Acronym / sponsor ID
- CGM-DPP / STUDY00009767
- Conditions
- PreDiabetes
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- State University of New York at BuffaloUniversity, hospital or other
- Study start
- 13 Apr 2026 (actual)
- Primary completion
- Mar 2028 (estimated)
- Study completion
- Mar 2028 (estimated)
- First posted
- 26 Aug 2025 (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.
Prediabetes affects over one-third of adults in the United States, placing them at a higher risk for developing type 2 diabetes and heart disease, which can lead to serious health complications and increased medical costs. Although a program called the Diabetes Prevention Program (DPP) has been shown to lower the risk of diabetes through healthy lifestyle changes, many people find it difficult to stick with these changes over the long term. This study seeks to find out if combining DPP coaching with continuous glucose monitoring (CGM) technology can help people stay on track with their health goals.
Detailed description
CGM devices give individuals real-time information about their blood sugar levels, which can help them understand how their diet, exercise, and daily habits impact their health. By pairing CGM technology with support from trained DPP coaches, this approach aims to make it easier for participants to maintain healthy behaviors. The study will involve 214 adults with prediabetes who will follow a 12-month program with regular check-ins to measure improvements in blood sugar control, weight loss, physical activity, and overall quality of life.
The goal is to show whether using CGM in combination with coaching can lead to better health outcomes and whether it is a cost-effective way to prevent diabetes. If successful, this approach could be used in healthcare settings across the country, helping more people prevent diabetes and lead healthier lives.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | Active comparator | Behavioral: ControlDiabetes Prevention Program |
| Intervention | Experimental | Behavioral: CGM-DPPDiabetes Prevention Program + Continuous Glucose Monitors/Coaching |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- adults aged 18 years or older,
- diagnosis of prediabetes, as defined by current clinical guidelines (HbA1c 5.7% to 6.4%, fasting plasma glucose 100-125 mg/dL, or 2-hour plasma glucose 140-199 mg/dL following a 75g oral glucose tolerance test),
- body mass index (BMI) of at least 24 kg/m² (or 22 kg/m² for Asian Americans),
- willingness to comply with all aspects of the study protocol, including attending coaching sessions and using CGM devices.
Key exclusion criteria (4 listed)
- Individuals will be excluded from the study if they
- have a diagnosis of type 1 or type 2 diabetes,
- are currently using CGMs or have medical contraindications to CGM use, such as severe skin allergies or implantable defibrillators, or
- are currently enrolled in another clinical trial for prediabetes. Additionally, using validated assessments, we will exclude participants with significant dementia, alcohol or drug abuse/dependency, active psychosis, or life expectancy less than 12 months as these conditions are likely to interfere with adherence to the intervention.
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 |
|---|---|---|
| CGM-DPPParticipants in the DPP who receive personalized CGM coaching. | Behavioural | Intervention |
| ControlParticipants in control group will be referred to DPP. | Behavioural | Control |
Primary outcome
Glycemic Control (HbA1c)
Time frame: Change from baseline HbA1c at 12 months post intervention follow-ups
Blood specimens (10 cc of blood) will be obtain by trained phlebotomists or nurse for HbA1c.
1 secondary outcome
Quality of Life as measured by SF-12
Time frame: Change from baseline quality of life measure at 12 months post intervention follow-ups
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 3 Nov 2026.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CGM-DPP in people with PreDiabetes, run by State University of New York at Buffalo at 1 site 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 4 inclusion and 4 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: looking for participants now, as of the sponsor's last update on 3 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Contact Raphael A Fraser, PhD, MS (7168295733, rfraser@buffalo.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Glycemic Control (HbA1c) (time frame: Change from baseline HbA1c at 12 months post intervention follow-ups). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 3 Nov 2026; AzTrials last refreshed its copy on 6 Nov 2026.