Intermittent CGM Use for Prediabetes

Palo Alto (17 mi)

Overseen byJessica A Schmitt, MD

Age: Any Age

Sex: Any

Travel: May be covered

Time Reimbursement: Varies

Trial Phase: N/A

Waitlist Available

Sponsor: University of Alabama at Birmingham

No Placebo Group

Trial Summary

What is the purpose of this trial?This trial is testing if using a device that tracks blood sugar levels can help young people with pre-diabetes manage their condition better. The device gives real-time feedback on blood sugar levels. Researchers want to see if adding this device to standard care improves health outcomes for these youths. Monitoring blood sugar levels in real-time can help in managing diabetes more effectively.

Eligibility Criteria

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

My body has reached a moderate level of physical development.

My body shows moderate to full physical development.

I am 14 years old or older.

My BMI is in the top 85% for my age group.

My metformin dose has been the same for the last month or I don't take metformin.

Exclusion Criteria

I have or had cancer.

I have been diagnosed with diabetes.

I regularly use steroids for a long-term condition.

My BMI is below the 85th percentile for my age.

Treatment Details

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.

2Treatment groups

Experimental Treatment

Active Control

Group I: CGM + Traditional CounselingExperimental Treatment2 Interventions

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.

Group II: ControlActive Control1 Intervention

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.