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

Continuous Glucose Monitors in the Management of Youth With Prediabetes

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).

Study Overview

• Status: Completed
• Conditions: Obesity; Insulin Resistance; PreDiabetes
• Intervention / Treatment: Device: Abbott Freestyle Libre 2; Other: Standard physical activity and nutritional counseling for prediabetes management

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 Type: Interventional
• Enrollment (Actual): 33
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Alabama
    • Birmingham, Alabama, United States, 35233
      • Children's of Alabama

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	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.
Active Comparator: 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.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
CGM Acceptability	Caregiver and patient acceptability of CGM use	6 months
Progression of prediabetes	change in hemoglobin A1c	6 months

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: University of Alabama at Birmingham
• Collaborators: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
• Investigators: Principal Investigator: Jessica A Schmitt, MD, University of Alabama at Birmingham

Study record dates

Study Major Dates

• Study Start (Actual): June 5, 2023
• Primary Completion (Actual): May 15, 2025
• Study Completion (Actual): May 15, 2025

Study Registration Dates

• First Submitted: August 15, 2022
• First Submitted That Met QC Criteria: August 15, 2022
• First Posted (Actual): August 17, 2022

Study Record Updates

• Last Update Posted (Actual): August 8, 2025
• Last Update Submitted That Met QC Criteria: August 4, 2025
• Last Verified: August 1, 2025

More Information

Terms related to this study

• Keywords: pediatrics; obesity; prediabetes
• Additional Relevant MeSH Terms: Endocrine System Diseases; Metabolic Diseases; Glucose Metabolism Disorders; Diabetes Mellitus; Hyperinsulinism; Hyperglycemia; Insulin Resistance; Prediabetic State; Glucose Intolerance
• Other Study ID Numbers: IRB-300009480; P30DK079626 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No