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

NCT ID: NCT05505565

Last Updated: 2025-08-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 33 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-06-05
• Study Completion Date: 2025-05-15

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.

Conditions

PreDiabetes; Obesity; Insulin Resistance

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

CGM + Traditional Counseling

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 Type: EXPERIMENTAL

Abbott Freestyle Libre 2

Intervention Type: DEVICE

Subjects will be educated on use of Abbott Freestyle Libre 2 and educated on how daily activities impact glucose.

Standard physical activity and nutritional counseling for prediabetes management

Intervention Type: OTHER

Subjects will be advised on recommendations for nutrition and activity goals for preventing progression of prediabetes.

Control

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.

Group Type: ACTIVE_COMPARATOR

Standard physical activity and nutritional counseling for prediabetes management

Intervention Type: OTHER

Subjects will be advised on recommendations for nutrition and activity goals for preventing progression of prediabetes.

Interventions

Abbott Freestyle Libre 2

Subjects will be educated on use of Abbott Freestyle Libre 2 and educated on how daily activities impact glucose.

Intervention Type: DEVICE

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.

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 11 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

NIH

Sponsor Role: collaborator

University of Alabama at Birmingham

OTHER

Sponsor Role: lead

Responsible Party

Jessica Schmitt

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jessica A Schmitt, MD

Role: PRINCIPAL_INVESTIGATOR

University of Alabama at Birmingham

Locations

Children's of Alabama

Birmingham, Alabama, United States

Countries

United States

Other Identifiers

P30DK079626

Identifier Type: NIH

Identifier Source: secondary_id

View Link

IRB-300009480

Identifier Type: -

Identifier Source: org_study_id