Trial of CGM Technology in Persons Living With Prediabetes

NCT07639593 | Not Yet Recruiting FDA Device

• 1 other identifier: IRB00143795
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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 used as part of care in patients living with type 1 or 2 diabetes on any kind of insulin therapy.

Conditions

Prediabetes

Keywords

Continuous Glucose Monitoring; A1C (or HbA1c); diabetes

Outcome Measures

Primary Outcomes (14)

• 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

  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

  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.

  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.

  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.

  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.

  Month 3

• Weight monitoring

  Weight measurement will be collected

  Baseline

• Weight monitoring

  Weight measurement will be collected

  Month 1

• Weight monitoring

  Weight measurement will be collected

  Month 2

• Weight monitoring

  Weight measurement will be collected

  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

  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

  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

  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

  Month 3

Secondary Outcomes (1)

• Continuous Glucose Monitoring As a Behavior Modification Tool Survey

  Month 3

Study Arms (2)

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.

Device: Stelo CGM

Control Group - no Device

NO INTERVENTION

50 subjects will be treated as standard of care with no CGM interventions.

Interventions

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.

Also known as: Simple Sugar Tracking

Stelo CGM Device

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Wake Forest University Health Sciences: lead

Study Sites (1)

Wake Forest University Health Sciences

Winston-Salem, North Carolina, 27157, United States

Location

MeSH Terms

Conditions

Prediabetic State; Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Catherine Price, MD

  Wake Forest University Health Sciences

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Meghan Willoughby, MD

CONTACT

317-938-5421; meghan.willoughby@advocatehealth.org

Catherine Price, MD

CONTACT

912-682-0558; Catherine.Price@wfusm.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: June 5, 2026
• First Posted: June 10, 2026
• Study Start: June 1, 2026
• Primary Completion (Estimated): March 1, 2027
• Study Completion (Estimated): March 1, 2027
• Last Updated: June 10, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)