At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Continuous Glucose Monitors in the Management of Youth With Prediabetes
In Brief
A clinical study evaluating Abbott Freestyle Libre 2 and Standard physical activity and nutritional counseling for prediabetes management for PreDiabetes and 2 related conditions. Completed, enrolled 54 participants across 1 site.
Detailed Summary
We are evaluating whether intermittent use of continuous glucose monitors (CGMs) in addition to standard nutritional counseling and physical activity counseling is associated with improved metabolic health for youth with pre-diabetes (PD).
Study Details
Timeline
Arms & 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.
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.
Caregivers of those randomized to the intervention group were enrolled to give their feedback on the continuous glucose monitor via surveys at the 3-month and 6-month visits. Outside these surveys, there were no other inputs or interventions to this group.
Interventions
Subjects will be educated on use of Abbott Freestyle Libre 2 and educated on how daily activities impact glucose.
Subjects will be advised on recommendations for nutrition and activity goals for preventing progression of prediabetes.