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

Study Overview
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Brief Summary
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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
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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.

Official Title
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Continuous Glucose Monitors in the Management of Youth With Prediabetes

Conditions
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PreDiabetes, Obesity, Insulin Resistance

Intervention / Treatment
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* Device: Abbott Freestyle Libre 2
* Other: Standard physical activity and nutritional counseling for prediabetes management


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 14 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Randomized, non-blinded, parallel, intervention vs control group
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: CGM + Traditional Counseling<br>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<br>* Subjects will be educated on use of Abbott Freestyle Libre 2 and educated on how daily activities impact glucose.<br>Other: Standard physical activity and nutritional counseling for prediabetes management<br>* Subjects will be advised on recommendations for nutrition and activity goals for preventing progression of prediabetes.<br>|
| Active Comparator: Control<br>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<br>* Subjects will be advised on recommendations for nutrition and activity goals for preventing progression of prediabetes.<br>|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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pediatrics, prediabetes, obesity