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

The University of Alabama at Birmingham

Status: Completed

Conditions: Insulin Resistance; Obesity; PreDiabetes

Treatments: Device: Abbott Freestyle Libre 2; Other: Standard physical activity and nutritional counseling for prediabetes management

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT05505565

IRB-300009480

P30DK079626 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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).

Full 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.

Enrollment: 33 patients

Sex: All

Ages: 11+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Age 11 or older
• English-speaking
• stable metformin dose for 1 month prior to enrollment or no metformin use
• baseline A1c of 5.7-6.4%
• 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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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33 participants in 2 patient groups

CGM + Traditional Counseling

Experimental group

Description:

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.

Treatment:

Other: Standard physical activity and nutritional counseling for prediabetes management

Device: Abbott Freestyle Libre 2

Control

Active Comparator group

Description:

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.

Treatment:

Other: Standard physical activity and nutritional counseling for prediabetes management