NCT05505565

Tolerability, Acceptance, and Utility of Intermittent CGM Use in Youth With Prediabetes

Continuous Glucose Monitors in the Management of Youth With Prediabetes

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 33 (actual)
• Sponsor: University of Alabama at Birmingham · Academic / Other
• Sex: All
• Age: 11 Years
• Healthy volunteers: Not accepted

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).

Detailed description

The purpose of this research study is to test if CGMs are tolerable to youth with pre-diabetes (PD) and their caregivers. We are also evaluating if CGMs add benefit to standard treatment in youth with prediabetes. The CGM in question, Abbott Freestyle Libre 2 is approved by the Food and Drug Administration (FDA) to treat patients aged 4 and up with diabetes. We want to determine if this CGM may benefit people who have PD. People who enter the study will either receive standard medical care for prediabetes or receive standard medical care for prediabetes plus use a CGM for 2 weeks each month to receive real-time biofeedback on their glucose levels during the day. There will be 3 visits over a 6-month period, baseline, 3-month, and 6-month visits. At each visit fasting labs will be obtained including: complete metabolic panel, lipid panel, pro-insulin, c-peptide, insulin. Anthropomorphics including body mass index, waist circumference, and hip circumference will be monitored.

Conditions

• PreDiabetes
• Obesity
• Insulin Resistance

Interventions

Type	Name	Description
DEVICE	Abbott Freestyle Libre 2	Subjects will be educated on use of Abbott Freestyle Libre 2 and educated on how daily activities impact glucose.
OTHER	Standard physical activity and nutritional counseling for prediabetes management	Subjects will be advised on recommendations for nutrition and activity goals for preventing progression of prediabetes.

Timeline

• Start date: 2023-06-05
• Primary completion: 2025-05-15
• Completion: 2025-05-15
• First posted: 2022-08-17
• Last updated: 2025-08-08

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study