Stelo CGM for Prediabetes

(CGM Trial)

MW
CP
Overseen ByCatherine Price, MD
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Wake Forest University Health Sciences
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests the Stelo continuous glucose monitor (CGM) to determine its effectiveness in helping people with prediabetes manage their blood sugar levels. Participants will either use the Stelo CGM for three months or receive standard care without the device. The trial is ideal for individuals who meet the American Diabetes Association's criteria for prediabetes and have a smartphone compatible with the CGM app. As an unphased trial, it offers participants the chance to contribute to innovative research that could improve prediabetes management.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that the Stelo CGM device is safe for prediabetes?

Research has shown that the Stelo Continuous Glucose Monitor (CGM) is safe for adults. The FDA approved it for purchase without a prescription for individuals aged 18 and older, confirming it meets safety standards for general use. Studies have found that this device employs accurate technology developed by Dexcom, a leader in glucose monitoring for over 25 years.

Although the Stelo CGM is generally safe, it is not recommended for individuals who frequently experience hypoglycemia, a condition where blood sugar levels drop too low. Most users, however, find the device easy to use and reliable for monitoring glucose levels.

Overall, the technology in the Stelo CGM has maintained a strong safety record, making it a dependable choice for glucose monitoring.12345

Why are researchers excited about this trial?

Unlike traditional treatments for prediabetes that often focus on lifestyle changes like diet and exercise or medications like metformin, the Stelo CGM device offers a continuous glucose monitoring approach. This device provides real-time glucose level tracking, which can empower users with immediate feedback on how their lifestyle choices impact their glucose levels. Researchers are excited because this could lead to more proactive and personalized management of prediabetes, potentially preventing the progression to type 2 diabetes more effectively than current methods.

What evidence suggests that the Stelo CGM device is effective for prediabetes?

This trial will compare the Stelo CGM device with standard care for individuals with prediabetes. Research has shown that continuous glucose monitors (CGMs) like the Stelo can help people with diabetes better control their blood sugar. Studies have found that using a CGM can improve blood sugar levels, such as lowering hemoglobin A1c, which measures long-term blood sugar control. The Stelo device demonstrates a 93% accuracy rate compared to standard lab tests. For those with prediabetes, the goal is to use a CGM to manage blood sugar and prevent diabetes. Overall, CGMs are associated with greater satisfaction and improved blood sugar management.15678

Who Is on the Research Team?

CP

Catherine Price, MD

Principal Investigator

Wake Forest University Health Sciences

Are You a Good Fit for This Trial?

This trial is for adults diagnosed with prediabetes who are interested in using a continuous glucose monitor (CGM) to help manage their blood sugar. People with other serious health conditions or those already using CGMs may not be eligible.

Inclusion Criteria

Subjects affiliated with one of the two institutional ambulatory clinics participating in this study who meet criteria for prediabetes listed on American Diabetes Association website, including A1c between 5.7% and 6.4%, and have reliable access to a smartphone device compatible with the CGM application
I am 18 years old or older.

Exclusion Criteria

Subjects without reliable access to a smartphone device compatible with the CGM application
Pregnant patients
I have diabetes with an A1c of 6.5% or higher.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants in the experimental group receive the Stelo CGM device for 3 months, while the control group receives standard care without CGM interventions

12 weeks
Monthly visits for data collection

Follow-up

Participants are monitored for safety and effectiveness after treatment, focusing on glycemic control, blood pressure, weight, and behavioral modifications

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Stelo CGM

Trial Overview

The study is testing the use of the Stelo continuous glucose monitor (CGM) in people with prediabetes, aiming to see how well it helps track and manage blood sugar levels over time.

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Active Control

Group I: Stelo CGM DeviceExperimental Treatment1 Intervention
Group II: Control Group - no DeviceActive Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Wake Forest University Health Sciences

Lead Sponsor

Trials
1,432
Recruited
2,506,000+

Citations

Dexcom G7 and Stelo: Key Differences and Insights

Stelo's target glucose range for those without diabetes or prediabetes is between 70–140 mg/dL, aiming for 96% time in range (TIR). For individuals with type 2 ...

Advances in Continuous Glucose Monitoring: Clinical ... - PMC

Studies show that people with diabetes (PwD) using CGM achieve better glycemic outcomes and greater satisfaction with their diabetes management.

Continuous Glucose Monitoring for Prediabetes

CGM use has been demonstrated to lower hemoglobin A1c (HbA1c) in individuals with T1D or T2D,6 and the hope is that CGM can be used as illustrated in the Figure ...

How accurate is Stelo? | Stelo by Dexcom

Stelo glucose data has proven to be 93% accurate when compared to a gold standard laboratory blood glucose test, making it the most accurate biosensor ...

Trial of CGM Technology in Persons Living With Prediabetes

Continuous Glucose Monitor (CGM) data tracks your interstitial glucose levels every few minutes, 24/7. It reveals exactly how meals, exercise, ...

Stelo Wearable Glucose Biosensor | No prescription CGM ...

The Stelo Glucose Biosensor is built on the most accurate6 continuous glucose monitoring technology from Dexcom, an industry leader in CGM for over 25 years.

Continuous Glucose Monitoring, Mobile Technology ... - NCBI

The intervention group had a 2.6% median reduction in time <70 mg/dL compared to 0.3% in the control group (p<0.001), with benefits seen in both ...

FDA Clears First Over-the-Counter Continuous Glucose ...

The FDA previously cleared the Stelo Glucose Biosensor System OTC for individuals 18 years and older in March 2024. “Children deserve access to ...