PrediabetesNCT07455435
Continuous Glucose Monitoring in Prediabetes
A study testing CGM Access in people with Prediabetes, run by University of Hartford.
Trial summary
This research explores how wearable glucose monitors might help prevent type 2 diabetes in people at risk of developing the disease. Type 2 diabetes affects more than 1 in 10 Americans and costs the nation $327 billion annually. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Prediabetes
- What is being tested?
- CGM Access
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- 21 Mar 2026to 1 May 2027
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults aged 18 years or older Prediabetes confirmed by the recent lab tests (within three month). If not available, it will be confirmed at lab Body mass index (BMI) >= 25 kg/m2 Ability to provide informed consent Ownership of a smartphone compatible with Dexcom G6 application Willing and able to comply with study procedures for 20 days
Who cannot join
- Diabetes and Glycemic Management:
- Diagnosed type 1 or type 2 diabetes mellitus
- Current use of glucose-lowering medications (metformin, sulfonylureas, GLP-1 agonists, SGLT2 inhibitors, insulin, etc.)
- HbA1c >= 6.5% or fasting plasma glucose >= 126 mg/dL
- Cardiovascular Conditions:
- History of cardiovascular disease (myocardial infarction, stroke, heart failure, coronary artery disease)
Show all 30Show fewer
- Peripheral artery disease
- Uncontrolled hypertension (systolic BP > 160 mmHg or diastolic BP > 100 mmHg)
- Raynaud phenomenon or other conditions affecting peripheral vascular assessment
- Atrial fibrillation or other arrhythmias affecting pulse wave velocity measurement
- Medications Affecting Vascular Function:
- Current use of vasoactive medications (nitrates, phosphodiesterase inhibitors)
- Recent changes (< 4 weeks) in antihypertensive medications
- Chronic use of non-steroidal anti-inflammatory drugs (NSAIDs)
- Systemic corticosteroid use
- Physical Activity Limitations:
- Physical disability or musculoskeletal condition preventing normal ambulation
- Use of mobility aids (wheelchair, walker, cane)
- Medical advice to limit physical activity
- Other Exclusions:
- Pregnancy or lactation
- Active cancer or cancer treatment within the past 5 years (excluding non-melanoma skin cancer)
- Chronic kidney disease (eGFR < 60 mL/min/1.73m2)
- Liver disease (ALT or AST > 3x upper limit of normal)
- Thyroid disease (unless stable on treatment for > 3 months)
- Current participation in a weight loss program or clinical trial
- Skin conditions preventing CGM sensor placement
- Known allergy to CGM adhesive
- Shift work or irregular sleep schedule (may affect CGM patterns)
- Planned travel during study period that would interfere with study visits
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Continuous Glucose Monitoring as a Tool to Promote Physical Activity in Prediabetes
This research explores how wearable glucose monitors might help prevent type 2 diabetes in people at risk of developing the disease. Type 2 diabetes affects more than 1 in 10 Americans and costs the nation $327 billion annually. Even though it's clear that physical activity helps prevent diabetes, and that even small increases in daily movement (like walking or climbing stairs) can significantly lower risk, getting people to be more active remains challenging.
A device called a continuous glucose monitor (CGM) might offer a solution. This small wearable sensor tracks blood sugar levels throughout the day and sends the information to a phone or watch. While these devices are already helping people who have diabetes manage their condition better, the investigators want to study if wearing a CGM may encourage at-risk people to become more physically active. The investigators are particularly interested in seeing whether real-time blood sugar data plus education can be an effective tool to promote lifestyle changes, such as walk more steps every day.
The study also aims to examine whether using a CGM helps stabilize blood sugar levels in prediabetes. The researchers believe that even short-term use of these monitors could lead to increased physical activity and more stable blood sugar levels, potentially helping prevent diabetes development.
Read the detailed description
The current research landscape shows Type 2 diabetes (T2D) as a major public health challenge, affecting more than 10% of Americans with staggering annual costs of $327 billion. Research has clearly established the protective role of physical activity in T2D prevention, with studies showing that even modest increases in daily activity (14 minutes) can reduce T2D risk by 9%, while sedentary behavior like television viewing can significantly increase risk by 30%. These findings underscore the critical importance of physical activity in diabetes prevention strategies.
Continuous Glucose Monitoring (CGM) technology has emerged as a valuable tool in diabetes management, with the American Diabetes Association now recommending its use for diabetes self-management. While CGM's effectiveness in improving blood sugar control among diagnosed T2D patients is well-documented, there's a notable gap in research regarding its potential as a preventive tool. Specifically, no studies have examined whether real-time glucose feedback from CGM devices might encourage increased physical activity among people at risk for developing T2D.
Individuals at risk for type 2 diabetes, such as with prediabetes, were chosen as the study population for several strategic reasons. First, this aligns with a prevention-focused approach, as research shows that lifestyle interventions can effectively delay or prevent diabetes onset in high-risk populations. Second, there's a significant knowledge gap regarding CGM use in prevention - while its benefits for diagnosed diabetes patients are well-documented, its potential as a preventive tool remains unexplored. The study specifically targets individuals with pre-diabetes diagnosis and BMI > 25, while excluding those with prior CGM experience or who use glucose-affecting medications to ensure valid results. This population choice also addresses health equity concerns, as type 2 diabetes disproportionately affects underserved communities, making prevention strategies particularly valuable for these groups.
- Conditions
- Prediabetes
- Being tested
- CGM Access
- 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 AccessBehavioural
The intervention is the access to the real-time glucose via a CGM system.
| Study group | Role | What they receive |
|---|---|---|
| CGM Blind group | No intervention | The control group will wear the CGM for 20 days but without access to the real-time glucose data (blind mode). They will receive the data upon completion of the study. |
| CGM Unblind group | Experimental | The CGM unblind group will wear the CGM for 20 days. They will have the real time glucose data during the study. Receives: Behavioral: CGM Access |
What is being measured
The primary outcome is the main question the study is designed to answer.
Physical activity level
step count
Measured: from day 1 to day 20
Secondary outcomes (3)
endothelial function
flow mediated dilation
Measured: At day 1 and day 20
arterial stiffness
pulse wave velocity
Measured: at day 1 and day 20
blood glucose
average blood glucose from the CGM sensor
Measured: from day 1 to day 20
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2026
- Study start21 Mar 2026 (estimated)
- Primary completion31 Dec 2026 (estimated)
- Study completion1 May 2027 (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.
- 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
- Model description
- The eligible participants will be randomly allocated to a control group and an experimental group. Both groups will wear CGM for 20 days, with only the experimental group will receive real-time glucose data during the study period. The CGM in the control group will be in the blind mode.
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Hartford
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jinghui Yang, University of Hartford
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07455435
- Sponsor's protocol ID
- 25-01-397
- Status last verified
- Feb 2026
- First submitted
- 15 Feb 2026
- Last updated
- 6 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: I will share the coded data with the reviewer or editor if needed.
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Continuous Glucose Monitoring as a Tool to Promote Physical Activity in Prediabetes
- ClinicalTrials.gov ID
- NCT07455435
- Acronym / sponsor ID
- 25-01-397
- Conditions
- Prediabetes
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- University of HartfordUniversity, hospital or other
- Study start
- 21 Mar 2026 (estimated)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 1 May 2027 (estimated)
- First posted
- 6 Mar 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 research explores how wearable glucose monitors might help prevent type 2 diabetes in people at risk of developing the disease. Type 2 diabetes affects more than 1 in 10 Americans and costs the nation $327 billion annually. Even though it's clear that physical activity helps prevent diabetes, and that even small increases in daily movement (like walking or climbing stairs) can significantly lower risk, getting people to be more active remains challenging.
A device called a continuous glucose monitor (CGM) might offer a solution. This small wearable sensor tracks blood sugar levels throughout the day and sends the information to a phone or watch. While these devices are already helping people who have diabetes manage their condition better, the investigators want to study if wearing a CGM may encourage at-risk people to become more physically active. The investigators are particularly interested in seeing whether real-time blood sugar data plus education can be an effective tool to promote lifestyle changes, such as walk more steps every day.
The study also aims to examine whether using a CGM helps stabilize blood sugar levels in prediabetes. The researchers believe that even short-term use of these monitors could lead to increased physical activity and more stable blood sugar levels, potentially helping prevent diabetes development.
Detailed description
The current research landscape shows Type 2 diabetes (T2D) as a major public health challenge, affecting more than 10% of Americans with staggering annual costs of $327 billion. Research has clearly established the protective role of physical activity in T2D prevention, with studies showing that even modest increases in daily activity (14 minutes) can reduce T2D risk by 9%, while sedentary behavior like television viewing can significantly increase risk by 30%. These findings underscore the critical importance of physical activity in diabetes prevention strategies.
Continuous Glucose Monitoring (CGM) technology has emerged as a valuable tool in diabetes management, with the American Diabetes Association now recommending its use for diabetes self-management. While CGM's effectiveness in improving blood sugar control among diagnosed T2D patients is well-documented, there's a notable gap in research regarding its potential as a preventive tool. Specifically, no studies have examined whether real-time glucose feedback from CGM devices might encourage increased physical activity among people at risk for developing T2D.
Individuals at risk for type 2 diabetes, such as with prediabetes, were chosen as the study population for several strategic reasons. First, this aligns with a prevention-focused approach, as research shows that lifestyle interventions can effectively delay or prevent diabetes onset in high-risk populations. Second, there's a significant knowledge gap regarding CGM use in prevention - while its benefits for diagnosed diabetes patients are well-documented, its potential as a preventive tool remains unexplored. The study specifically targets individuals with pre-diabetes diagnosis and BMI > 25, while excluding those with prior CGM experience or who use glucose-affecting medications to ensure valid results. This population choice also addresses health equity concerns, as type 2 diabetes disproportionately affects underserved communities, making prevention strategies particularly valuable for these groups.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- The eligible participants will be randomly allocated to a control group and an experimental group. Both groups will wear CGM for 20 days, with only the experimental group will receive real-time glucose data during the study period. The CGM in the control group will be in the blind mode.
| Arm | Type | Receives |
|---|---|---|
| CGM Blind group | No intervention | –The control group will wear the CGM for 20 days but without access to the real-time glucose data (blind mode). They will receive the data upon completion of the study. |
| CGM Unblind group | Experimental | Behavioral: CGM AccessThe CGM unblind group will wear the CGM for 20 days. They will have the real time glucose data during the study. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Adults aged 18 years or older Prediabetes confirmed by the recent lab tests (within three month). If not available, it will be confirmed at lab Body mass index (BMI) >= 25 kg/m2 Ability to provide informed consent Ownership of a smartphone compatible with Dexcom G6 application Willing and able to comply with study procedures for 20 days
Key exclusion criteria (30 listed)
- Diagnosed type 1 or type 2 diabetes mellitus
- Current use of glucose-lowering medications (metformin, sulfonylureas, GLP-1 agonists, SGLT2 inhibitors, insulin, etc.)
- HbA1c >= 6.5% or fasting plasma glucose >= 126 mg/dL
- History of cardiovascular disease (myocardial infarction, stroke, heart failure, coronary artery disease)
- Peripheral artery disease
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 AccessThe intervention is the access to the real-time glucose via a CGM system. | Behavioural | CGM Unblind group |
Primary outcome
Physical activity level
Time frame: from day 1 to day 20
step count
3 secondary outcomes
endothelial function
Time frame: At day 1 and day 20
arterial stiffness
Time frame: at day 1 and day 20
blood glucose
Time frame: from day 1 to day 20
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 6 Mar 2026.
- Individual participant dataSharing planned: Yes. I will share the coded data with the reviewer or editor if needed.
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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.
Questions about this trial
What is this clinical trial studying?
A study testing CGM Access in people with Prediabetes, run by University of Hartford.
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 1 inclusion and 30 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 6 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
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 Jinghui Yang, PT, MPT, PhD (347-429-0843, jiyang@hartford.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Physical activity level (time frame: from day 1 to day 20). 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 6 Mar 2026.