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

NCT05505565 | Completed Results FDA Device

• 2 other identifiers: IRB-300009480P30DK079626
• Study Type: interventional
• Target: 54
• Locations: 1 country
• Sites: 1

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).

Conditions

PreDiabetes; Obesity; Insulin Resistance

Keywords

pediatrics; prediabetes; obesity

Outcome Measures

Primary Outcomes (2)

• CGM Acceptability

  Caregiver and patient acceptability of CGM use

  6 months

• Change in Measured % HbA1c From Baseline to 6-months

  The difference in measured percentage of glycosylated hemoglobin (hemoglobin A1c) was obtained by subtracting the 6-month value from the baseline value for all subjects with paired data available. A negative result indicates a reduction (improvement) in hemoglobin A1c over the period.

  6 months

Secondary Outcomes (4)

• Change in HOMA-IR From Baseline to 6-months.

  6 months

• Change in Triglyceride, HDL, LDL, and Total Cholesterol From Baseline to 6-month

  6 months

• Changes in Liver Enzymes From Baseline to 6-months.

  6 months

• Glycemic Metrics

  6 months

Study Arms (3)

CGM + Traditional Counseling

EXPERIMENTAL

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; Other: Standard physical activity and nutritional counseling for prediabetes management

Control

ACTIVE COMPARATOR

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

Caregivers of CGM + Traditional Counseling Group

NO INTERVENTION

Caregivers of those randomized to the intervention group were enrolled to give their feedback on the continuous glucose monitor via surveys at the 3-month and 6-month visits. Outside these surveys, there were no other inputs or interventions to this group.

Interventions

Abbott Freestyle Libre 2 DEVICE

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

CGM + Traditional Counseling

Standard physical activity and nutritional counseling for prediabetes management OTHER

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

CGM + Traditional Counseling; Control

Eligibility Criteria

• Age: 11 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• University of Alabama at Birmingham: lead
• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): collaborator

Study Sites (1)

Children's of Alabama

Birmingham, Alabama, 35233, United States

Location

MeSH Terms

Conditions

Prediabetic State; Obesity; Insulin Resistance

Interventions

Nutrition Assessment

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Overweight; Overnutrition; Nutrition Disorders; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Hyperinsulinism

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Epidemiologic Measurements; Public Health; Environment and Public Health

Limitations and Caveats

CGM data is limited due to the number of participants with data available at baseline and 6-month follow-up. While fasting labs were requested, participants were not supervised for the 8-hours prior to their study visits, so confounding by non-fasting is possible.

Results Point of Contact

• Title: Jessica Schmitt
• Organization: University of Alabama at Birmingham

jessicaschmitt@uabmc.edu

205-638-9107

Study Officials

• Jessica A Schmitt, MD

  University of Alabama at Birmingham

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: Randomized, non-blinded, parallel, intervention vs control group

Study Record Dates

• First Submitted: August 15, 2022
• First Posted: August 17, 2022
• Study Start: June 5, 2023
• Primary Completion: May 15, 2025
• Study Completion: May 15, 2025
• Last Updated: June 17, 2026
• Results First Posted: June 17, 2026

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)