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

Not Applicable

Active, not recruiting

• Conditions: PreDiabetes; Obesity; Insulin Resistance
• Interventions: Device: Abbott Freestyle Libre 2; Other: Standard physical activity and nutritional counseling for prediabetes management

• Registration Number: NCT05505565
• Lead Sponsor: University of Alabama at Birmingham

Brief 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.

Study Timeline

• Study First Submitted: 2022-08-15
• Study First Submitted QC: 2022-08-15
• Study First Posted: 2022-08-17
• Study Start: 2023-06-05
• Status Verified: 2024-08
• Last Update Submitted: 2025-04-14
• Last Update Posted: 2025-04-16
• Primary Completion: 2025-05-15
• Study Completion: 2025-05-15

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 33

Inclusion Criteria

• Age 14 or older
• English-speaking
• stable metformin dose for 1 month prior to enrollment or no metformin use
• baseline A1c of 5.7-6.4%
• tanner stage 3 or above
• BMI > = 85% for age

Exclusion Criteria

• BMI < 85% for age
• chronic steroid use
• diagnosis of type 1 diabetes, type 2 diabetes, other forms of diabetes
• current or history of malignancy

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
CGM + Traditional Counseling	Abbott Freestyle Libre 2	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.
Control	Standard physical activity and nutritional counseling for prediabetes management	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.
CGM + Traditional Counseling	Standard physical activity and nutritional counseling for prediabetes management	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.

Primary Outcome Measures

Name	Time	Method
CGM Acceptability	6 months	Caregiver and patient acceptability of CGM use
Progression of prediabetes	6 months	change in hemoglobin A1c

Secondary Outcome Measures

Name	Time	Method
Glycemic metrics	6 months	CGM data including: time in target range, time above target range, post-prandial glucose excursion
Hyperlipidemia	6 months	LDL, triglyceride, HDL, total cholesterol measurements
Transaminitis	6 months	AST, ALT
Insulin sensitivity	6 months	HOMA-IR, fasting c-peptide, fasting pro-insulin

Trial Locations

Locations (1)

Children's of Alabama; 🇺🇸 Birmingham, Alabama, United States