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

Obesity Clinical Trial

Official title:

Continuous Glucose Monitors in the Management of Youth With Prediabetes

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05505565
• Other study ID #: IRB-300009480
• Status: Recruiting
• Phase: N/A
• Start date: June 5, 2023
• Est. completion date: January 30, 2025

Study information

• Verified date: June 2024
• Source: University of Alabama at Birmingham
• Contact: Jessica A Schmitt, MD
• Phone: 2056385033
• Email: jessicaschmitt[@]uabmc.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 33
• Est. completion date: January 30, 2025
• Est. primary completion date: January 30, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 14 Years and older

Eligibility

Inclusion Criteria:

• Age 14 or older

• English-speaking

• stable metformin dose for 1 month prior to enrollment or no metformin use

• baseline A1c of 5.7-6.4%

• tanner stage 3 or above

• 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

Related Conditions & MeSH terms

• Glucose Intolerance
• Insulin Resistance
• Obesity
• PreDiabetes
• Prediabetic State

Intervention

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.

Locations

Country	Name	City	State
United States	Children's of Alabama	Birmingham	Alabama

Sponsors (1)

Lead Sponsor	Collaborator
University of Alabama at Birmingham

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	CGM Acceptability	Caregiver and patient acceptability of CGM use	6 months
Primary	Progression of prediabetes	change in hemoglobin A1c	6 months
Secondary	Insulin sensitivity	HOMA-IR, fasting c-peptide, fasting pro-insulin	6 months
Secondary	Hyperlipidemia	LDL, triglyceride, HDL, total cholesterol measurements	6 months
Secondary	Transaminitis	AST, ALT	6 months
Secondary	Glycemic metrics	CGM data including: time in target range, time above target range, post-prandial glucose excursion	6 months