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

NCT05505565 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 33

Last updated 2025-08-08

No results posted yet for this study

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).

Conditions

Interventions

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.

Sponsors & Collaborators

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

    collaborator NIH

  • University of Alabama at Birmingham

    lead OTHER

Principal Investigators

  • Jessica A Schmitt, MD · University of Alabama at Birmingham

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
11 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-06-05
Primary Completion
2025-05-15
Completion
2025-05-15
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05505565 on ClinicalTrials.gov