NCT07639593

Trial of CGM Technology in Persons Living With Prediabetes

Not Yet Recruiting
NAAges 18+InterventionalSupportive care
Wake Forest University Health Sciences
~100 participants
Updated 2026-06-24 on ClinicalTrials.gov
What's tested:Stelo CGM

At a glance

Recruiting sites
0 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
A1c value
Measured over Baseline
+13 more outcomes measured
Prediabetes
1 sites across 1 states
North Carolina1
  • Catherine Price, MD · PRINCIPAL_INVESTIGATOR · Wake Forest University Health Sciences

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Eligibility criteria

Inclusion

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

Exclusion

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
  • A1c valueBaseline

    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

  • A1c valueMonth 3

    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

  • CGM valueBaseline

    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.

  • CGM valueMonth 1

    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.

  • CGM valueMonth 2

    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.

  • CGM valueMonth 3

    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.

  • Weight monitoringBaseline

    Weight measurement will be collected

  • Weight monitoringMonth 1

    Weight measurement will be collected

  • Weight monitoringMonth 2

    Weight measurement will be collected

  • Weight monitoringMonth 3

    Weight measurement will be collected

  • Blood Pressure MonitoringBaseline

    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

  • Blood Pressure MonitoringMonth 1

    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

  • Blood Pressure MonitoringMonth 2

    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

  • Blood Pressure MonitoringMonth 3

    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