PrediabetesCGMNCT07639593
Trial of CGM Technology in Persons Living With Prediabetes
A study testing Stelo CGM in people with Prediabetes, run by Wake Forest University Health Sciences at 1 site in United States.
Trial summary
Continuous glucose monitor (CGM) technology has become increasingly prevalent in the population and has the ability to transform care of patients living with prediabetes. While the technology was initially utilized primarily by patients living with type 1 diabetes using insulin pump therapy, it has become more widely… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Prediabetes
- What is being tested?
- Stelo CGM
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2027to Nov 2027
- Phase
- Interventional
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
- Subjects affiliated with one of the two institutional ambulatory clinics participating in this study who are meeting criteria for prediabetes listed on American Diabetes Association website, which includes A1c = or > than 5.7% and < or = 6.4%, who also have reliable access to a smartphone device compatible with the CGM application
- Greater than or equal to 18 years old
Who cannot join
- Subjects who have been diagnosed with type 1 or type 2 diabetes mellitus, as defined as A1c > or = 6.5%
- Subjects who do not have reliable access to a smartphone device compatible with the CGM application
- Pregnant patients
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
Wake Forest University Health Sciences
Winston-Salem, North Carolina, 27157
Meghan Willoughby, MD, 317-938-5421, meghan.willoughby@advocatehealth.org
Catherine Price, MD, 912-682-0558, Catherine.Price@wfusm.edu
About this study
Official title: Trial of Continuous Glucose Monitoring (CGM) Technology in Persons Living With Prediabetes
Continuous glucose monitor (CGM) technology has become increasingly prevalent in the population and has the ability to transform care of patients living with prediabetes. While the technology was initially utilized primarily by patients living with type 1 diabetes using insulin pump therapy, it has become more widely used as part of care in patients living with type 1 or 2 diabetes on any kind of insulin therapy.
Read the detailed description
Additional investigation is strongly needed to further evaluate the health impacts of CGM technology in persons living with prediabetes. This study is looking to study the impact that CGM technology could have on glycemic control in patients with prediabetes, as well as secondary outcomes, such as blood pressure, weight, and patient insight into their condition and the effect on lifestyle interventions on glycemic control. The primary objective of this study is to determine the effect of CGM technology on glycemic control in patients with prediabetes, measured by the endpoints of A1c and CGM data. Specifically, CGM data will include Time-In-Range (TIR), Time-AboveRange (TAR), Time-Below-Range (TBR), Glycemic management indicator (GMI), and variability measures. Secondary endpoints include blood pressure, weight, and standardized survey data assessing behavioral modifications as a result of CGM technology.
- Conditions
- Prediabetes
- Being tested
- Stelo CGM
- Keywords
- Continuous Glucose Monitoring, A1C (or HbA1c), diabetes
- Medical subject headings
- Prediabetic State, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Stelo CGMDevice
Also called Simple Sugar Tracking
The Stelo Glucose Biosensor is built on the most accurate continuous glucose monitoring technology from Dexcom and is simple and painless to apply. By sending glucose levels directly to your smartphone,* it gives you just the right amount of information to work with.
| Study group | Role | What they receive |
|---|---|---|
| Stelo CGM Device | Experimental | 50 subjects will receive the Stelo CGM and utilize device for a duration of 3 months while enrolled in the study. Receives: Device: Stelo CGM |
| Control Group - no Device | No intervention | 50 subjects will be treated as standard of care with no CGM interventions. |
What is being measured
The primary outcome is the main question the study is designed to answer.
A1c value
An A1C test measures your average blood sugar levels over the past 2 to 3 months. It is reported as a percentage. A result below 5.7% is considered normal, 5.7% to 6.4% indicates prediabetes, and 6.5% or higher indicates diabetes - the lower the value is more normal
Measured: Baseline
A1c value
An A1C test measures your average blood sugar levels over the past 2 to 3 months. It is reported as a percentage. A result below 5.7% is considered normal, 5.7% to 6.4% indicates prediabetes, and 6.5% or higher indicates diabetes - the lower the value is more normal
Measured: Month 3
CGM value
Continuous Glucose Monitor (CGM) data tracks your interstitial glucose levels every few minutes, 24/7. It reveals exactly how meals, exercise, medications, and sleep impact your blood sugar in real-time, helping you and your healthcare provider identify specific patterns and trends Time in Range (TIR): The percentage of time spent in your target range (typically 70-180 mg/dL). Goal: Above 70%.Time Above Range (TAR): Time spent with high blood sugar (Levels 1 and 2). Goal: Keep as low as possible. Time Below Range (TBR): Time spent with low blood sugar (hypoglycemia). Goal: Less than 4% of the time, to eliminate dangerous lows.
Measured: Baseline
CGM value
Continuous Glucose Monitor (CGM) data tracks your interstitial glucose levels every few minutes, 24/7. It reveals exactly how meals, exercise, medications, and sleep impact your blood sugar in real-time, helping you and your healthcare provider identify specific patterns and trends Time in Range (TIR): The percentage of time spent in your target range (typically 70-180 mg/dL). Goal: Above 70%.Time Above Range (TAR): Time spent with high blood sugar (Levels 1 and 2). Goal: Keep as low as possible. Time Below Range (TBR): Time spent with low blood sugar (hypoglycemia). Goal: Less than 4% of the time, to eliminate dangerous lows.
Measured: Month 1
CGM value
Continuous Glucose Monitor (CGM) data tracks your interstitial glucose levels every few minutes, 24/7. It reveals exactly how meals, exercise, medications, and sleep impact your blood sugar in real-time, helping you and your healthcare provider identify specific patterns and trends Time in Range (TIR): The percentage of time spent in your target range (typically 70-180 mg/dL). Goal: Above 70%.Time Above Range (TAR): Time spent with high blood sugar (Levels 1 and 2). Goal: Keep as low as possible. Time Below Range (TBR): Time spent with low blood sugar (hypoglycemia). Goal: Less than 4% of the time, to eliminate dangerous lows.
Measured: Month 2
CGM value
Continuous Glucose Monitor (CGM) data tracks your interstitial glucose levels every few minutes, 24/7. It reveals exactly how meals, exercise, medications, and sleep impact your blood sugar in real-time, helping you and your healthcare provider identify specific patterns and trends Time in Range (TIR): The percentage of time spent in your target range (typically 70-180 mg/dL). Goal: Above 70%.Time Above Range (TAR): Time spent with high blood sugar (Levels 1 and 2). Goal: Keep as low as possible. Time Below Range (TBR): Time spent with low blood sugar (hypoglycemia). Goal: Less than 4% of the time, to eliminate dangerous lows.
Measured: Month 3
Weight monitoring
Weight measurement will be collected
Measured: Baseline
Weight monitoring
Weight measurement will be collected
Measured: Month 1
Weight monitoring
Weight measurement will be collected
Measured: Month 2
Weight monitoring
Weight measurement will be collected
Measured: Month 3
Blood Pressure Monitoring
Systolic (Top Number)Diastolic (Bottom Number)
Normal - Less than 120and Less than 80
Elevated - 120 - 129 and Less than 80
Hypertension Stage 1 - 130 - 139 or 80 - 89
Hypertension Stage 2 -140 or higher or 90 or higher
Hypertensive Crisis - Higher than 180 and/or Higher than 120
Measured: Baseline
Blood Pressure Monitoring
Systolic (Top Number)Diastolic (Bottom Number)
Normal - Less than 120and Less than 80
Elevated - 120 - 129 and Less than 80
Hypertension Stage 1 - 130 - 139 or 80 - 89
Hypertension Stage 2 -140 or higher or 90 or higher
Hypertensive Crisis - Higher than 180 and/or Higher than 120
Measured: Month 1
Blood Pressure Monitoring
Systolic (Top Number)Diastolic (Bottom Number)
Normal - Less than 120and Less than 80
Elevated - 120 - 129 and Less than 80
Hypertension Stage 1 - 130 - 139 or 80 - 89
Hypertension Stage 2 -140 or higher or 90 or higher
Hypertensive Crisis - Higher than 180 and/or Higher than 120
Measured: Month 2
Blood Pressure Monitoring
Systolic (Top Number)Diastolic (Bottom Number)
Normal - Less than 120and Less than 80
Elevated - 120 - 129 and Less than 80
Hypertension Stage 1 - 130 - 139 or 80 - 89
Hypertension Stage 2 -140 or higher or 90 or higher
Hypertensive Crisis - Higher than 180 and/or Higher than 120
Measured: Month 3
Secondary outcomes (1)
Continuous Glucose Monitoring As a Behavior Modification Tool Survey
The results will be discussed by describing the percent of patients that said "Yes," "No," or "I don't know" to the questions - percentage data
Measured: Month 3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jun 2026
- Study startApr 2027 (estimated)
- Primary completionNov 2027 (estimated)
- Study completionNov 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 50 subjects will receive the Stelo CGM and utilize device for a duration of 3 months while enrolled in the study. Control group: 50 subjects will be treated as standard of care with no CGM interventions.
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Wake Forest University Health Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Catherine Price, MD, Principal investigator, Wake Forest University Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07639593
- Sponsor's protocol ID
- IRB00143795
- Acronym
- CGM
- Status last verified
- May 2026
- First submitted
- 5 Jun 2026
- Last updated
- 23 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No