Intermittent CGM Use for Prediabetes
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial aims to determine if occasional use of a continuous glucose monitor (CGM) can improve metabolic health in young people with prediabetes. Participants in one group will use the Abbott Freestyle Libre 2 CGM (a device for monitoring glucose levels) for two weeks each month and receive standard advice on nutrition and physical activity. The other group will receive the usual care for prediabetes. This trial suits English-speaking youth aged 11 and older with prediabetes, stable or no metformin use, and a higher-than-average body weight for their age. As an unphased trial, it offers a unique opportunity to contribute to understanding how CGM can benefit young people with prediabetes.
Do I need to stop my current medications for the trial?
The trial does not specify if you need to stop taking your current medications, but you must have a stable metformin dose for 1 month before joining or not be using metformin at all.
What prior data suggests that the Abbott Freestyle Libre 2 is safe for use in youth with pre-diabetes?
Research shows that the Abbott Freestyle Libre 2, a continuous glucose monitor (CGM), is safe to use. This device checks glucose levels every minute and is already used by many people with diabetes. Studies have found that it lowers the chances of hospital visits for heart problems in people with diabetes, indicating it is well-tolerated.
The Freestyle Libre 2 has FDA approval for people with diabetes, confirming it has passed safety tests for that condition. Although this study will focus on prediabetes, the existing approval provides some confidence in its safety. For any concerns, discussing them with a doctor is always advisable.12345Why are researchers excited about this trial?
Researchers are excited about using intermittent Continuous Glucose Monitoring (CGM) with the Abbott Freestyle Libre 2 for prediabetes because it offers a unique, hands-on way for individuals to manage their blood sugar levels. Unlike standard treatments that rely on sporadic lab tests or finger-prick blood glucose checks, this device provides real-time insights into glucose trends. This continuous feedback can empower users to make immediate lifestyle changes, potentially preventing the progression to type 2 diabetes. Additionally, the integration with a physical activity monitoring platform like Sworkit® encourages a holistic approach, combining dietary awareness with exercise, which is crucial for managing prediabetes effectively.
What evidence suggests that intermittent CGM use is effective for prediabetes?
Research shows that the Abbott Freestyle Libre 2 system can improve health for people with diabetes. Studies have found that it enhances blood sugar control over time by lowering HbA1c levels, a measure of average blood sugar. Users also experience less time with high blood sugar levels. Additionally, using the device is associated with fewer hospital visits for heart problems in people with diabetes. In this trial, participants in the "CGM + Traditional Counseling" arm will use the Abbott Freestyle Libre 2 intermittently, which may indicate potential benefits for those with prediabetes as well.23678
Who Is on the Research Team?
Jessica A Schmitt, MD
Principal Investigator
University of Alabama at Birmingham
Are You a Good Fit for This Trial?
This trial is for English-speaking youth aged 14 or older with prediabetes, indicated by an A1c level of 5.7-6.4%. Participants should be at a Tanner stage 3 or above and have a BMI in the 85th percentile or higher for their age. They must not use chronic steroids, have any type of diabetes other than prediabetes, or have a current or past cancer diagnosis.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Baseline
Initial assessments and baseline measurements including fasting labs and anthropomorphics
Treatment
Participants receive standard medical care for prediabetes, with the experimental group using CGM intermittently for 2 weeks each month
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Abbott Freestyle Libre 2
Trial Overview
The study tests if using the Abbott Freestyle Libre 2 CGM intermittently, along with standard advice on diet and exercise, helps improve metabolic health in young people with prediabetes compared to just counseling alone.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Active Control
Subjects in this arm will receive intermittent CGM to be used for 2-weeks each month for the 6-month study period. They will be required to wear a CGM during baseline, 3-month, and 6-month periods. Additional CGM sensors will be supplied for months 1, 2, 4, and 5 and will be optional. They will be provided with a Sworkit(R) account to monitor physical activity completed through the Sworkit(R) website/platform.
Subjects in this arm will receive standard medical care for pre-diabetes. They will be provided with a Sworkit(R) account to monitor physical activity completed through the Sworkit(R) website/platform.
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of Alabama at Birmingham
Lead Sponsor
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Collaborator
Published Research Related to This Trial
Citations
Adult & Pediatric Outcomes
Adult patients using the Libre app† platform experienced 5% greater TIR compared with adult patients using readers‡10: Less time in hyperglycemia.
2.
abbott.com
abbott.com/corpnewsroom/diabetes-care/diabetes-and-heart-risk-two-battles-one-device.htmlDiabetes and Heart Risk: Two Battles, One Device
Libre technology is linked with reduced cardiovascular disease-related hospitalization for people with diabetes.
Analysis of “Accuracy of a 14-Day Factory Calibrated ...
1. Abbott MediaRoom. New Real-World Data Show that Abbott's FreeStyle Libre System Delivers Positive Health Outcomes for People with Type 1 and Type 2 Diabetes.
FreeStyle Libre Clinical Evidence
The FreeStyle Libre portfolio helped reduce HbA1c*†1-13, hypoglycemia*†14-15, work absenteeism*†16-17, and resource utilization*†18-21, among patients with ...
Cost-Effectiveness of FreeStyle Libre for Glucose Self ...
The use of FreeStyle Libre has been found to improve glycated hemoglobin (HbA1c) levels, reduce hypoglycemia, and increase the time spent in the ...
FreeStyle Libre 2 Continuous Glucose Monitor
It's the longest-lasting integrated continuous glucose monitoring (iCGM) system on the market, giving you glucose readings every minute.
FreeStyle Libre Continuous Glucose Monitoring | FreeStyle ...
The FreeStyle Libre 3 Plus sensor lets you see your glucose levels in real time so you can make more confident choices 1 and lower your A1C.
8.
abbott.mediaroom.com
abbott.mediaroom.com/2025-05-15-Abbotts-Libre-R-Technology-is-First-Continuous-Glucose-Monitor-Associated-with-Reduced-Hospitalizations-for-Heart-Complications-in-People-with-DiabetesAbbott's Libre® Technology is First Continuous Glucose ...
New data reveal a 78% reduction in cardiovascular disease-related hospitalizations for people living with Type 1 diabetes with prior severe low ...
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