An interventional study of Stelo CGM in Prediabetes, sponsored by Wake Forest University Health Sciences. Not yet recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-23.
Sponsored by Wake Forest University Health Sciences · Not applicable, Interventional, and Supportive care
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.
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.
918 studies on the registry are indexed under Prediabetic State; 232 are open to participants now.
This study's planned enrollment of 100 is above the median of 62 across 762 interventional studies indexed under Prediabetic State.
Browse Prediabetic State studies →Wake Forest University Health Sciences is the lead sponsor of 1,351 studies on the registry; 201 are open to participants now.
Of its 332 completed or terminated interventional studies of FDA-regulated products, 251 (76%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
50 subjects will receive the Stelo CGM and utilize device for a duration of 3 months while enrolled in the study.
Device: Stelo CGM
50 subjects will be treated as standard of care with no CGM interventions.
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.
Also known as: Simple Sugar Tracking
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
Time frame: 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
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Month 3
Weight monitoring
Weight measurement will be collected
Time frame: Baseline
Weight monitoring
Weight measurement will be collected
Time frame: Month 1
Weight monitoring
Weight measurement will be collected
Time frame: Month 2
Weight monitoring
Weight measurement will be collected
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: Month 3
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
Time frame: Month 3
Plan to share: No
No publications or documents are linked to this record.
Start is estimated for Apr 2027; primary completion for Nov 2027, 7 months later.
Of 378 non-industry interventional studies with no phase under Prediabetic State, half reached primary completion within 25 months of starting (the median), counting those still running; a quarter within 12 and three quarters within 39. This study's planned 7 months is below that.
Counting every sponsor, half of 424 studies reached it within 23 months; a quarter within 11 and three quarters within 37.
Since we started tracking on Sep 25, 2026, the dates moved once, on Oct 23, 2026: start Oct 2026 → Apr 2027, primary completion May 2027 → Nov 2027 and completion May 2027 → Nov 2027.
Earlier changes are on the record history on ClinicalTrials.gov ↗
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in May 2026. You cannot join it, but the record below documents what was studied.
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