Trial of CGM Technology in Persons Living With Prediabetes (CGM)

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Prediabetes
• Intervention / Treatment: Device: Stelo CGM

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.

• Study Type: Interventional
• Enrollment (Estimated): 100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Meghan Willoughby, MD; Phone Number: 317-938-5421; Email: meghan.willoughby@advocatehealth.org
• Study Contact Backup: Name: Catherine Price, MD; Phone Number: 912-682-0558; Email: Catherine.Price@wfusm.edu

Study Locations

• United States
  • North Carolina
    • Winston-Salem, North Carolina, United States, 27157
      • Wake Forest University Health Sciences
      • Contact: Meghan Willoughby, MD; Phone Number: 317-938-5421; Email: meghan.willoughby@advocatehealth.org
      • Contact: Catherine Price, MD; Phone Number: 912-682-0558; Email: Catherine.Price@wfusm.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Stelo CGM Device; 50 subjects will receive the Stelo CGM and utilize device for a duration of 3 months while enrolled in the study.	Device: Stelo CGM; 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
No Intervention: Control Group - no Device; 50 subjects will be treated as standard of care with no CGM interventions.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	Month 3

Collaborators and Investigators

• Sponsor: Wake Forest University Health Sciences
• Investigators: Principal Investigator: Catherine Price, MD, Wake Forest University Health Sciences

Study record dates

Study Major Dates

• Study Start (Estimated): October 1, 2026
• Primary Completion (Estimated): May 1, 2027
• Study Completion (Estimated): May 1, 2027

Study Registration Dates

• First Submitted: June 5, 2026
• First Submitted That Met QC Criteria: June 5, 2026
• First Posted (Actual): June 10, 2026

Study Record Updates

• Last Update Posted (Actual): August 27, 2026
• Last Update Submitted That Met QC Criteria: August 26, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: diabetes; Continuous Glucose Monitoring; A1C (or HbA1c)
• Additional Relevant MeSH Terms: Endocrine System Diseases; Metabolic Diseases; Glucose Metabolism Disorders; Nutritional and Metabolic Diseases; Diabetes Mellitus; Prediabetic State
• Other Study ID Numbers: IRB00143795

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No