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NCT Number: NCT07639593

Trial of 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.

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Key information

Conditions

PreDiabetes Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases Prediabetic State

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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 criteria

  • 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

Treatment and study plan

Stelo CGM

Device

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.

Other names: Simple Sugar Tracking

Primary outcomes

  1. A1c value

    Time frame: Baseline

    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

  2. A1c value

    Time frame: Month 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

  3. CGM value

    Time frame: Baseline

    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.

  4. CGM value

    Time frame: Month 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.

  5. CGM value

    Time frame: Month 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.

  6. CGM value

    Time frame: Month 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.

  7. Weight monitoring

    Time frame: Baseline

    Weight measurement will be collected

  8. Weight monitoring

    Time frame: Month 1

    Weight measurement will be collected

  9. Weight monitoring

    Time frame: Month 2

    Weight measurement will be collected

  10. Weight monitoring

    Time frame: Month 3

    Weight measurement will be collected

  11. Blood Pressure Monitoring

    Time frame: Baseline

    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

  12. Blood Pressure Monitoring

    Time frame: Month 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

  13. Blood Pressure Monitoring

    Time frame: Month 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

  14. Blood Pressure Monitoring

    Time frame: Month 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

Secondary outcomes

  1. Continuous Glucose Monitoring As a Behavior Modification Tool Survey

    Time frame: Month 3

    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

Study contacts

Contact information is provided by the study sponsor or research team.

Catherine Price, MD

CONTACT

[email protected]

912-682-0558

Meghan Willoughby, MD

CONTACT

[email protected]

317-938-5421

Sponsors and collaborators

Lead sponsor

Wake Forest University Health Sciences

Other

Registry information

Official study title

Trial of Continuous Glucose Monitoring (CGM) Technology in Persons Living With Prediabetes

Acronym: CGM

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Jun 10, 2026
Registry last updated
Jun 24, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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