CGM and Lifestyle Changes in Patients with Impaired Glucose Tolerance

Launched by NEMOURS CHILDREN'S CLINIC · May 19, 2022

Keywords

ClinConnect Summary

This clinical trial is studying how using a continuous glucose monitor (CGM) can help children and teenagers with impaired glucose tolerance (a condition where blood sugar levels are higher than normal but not high enough to be diabetes) make healthier lifestyle choices. Researchers believe that having real-time data about their blood sugar levels may encourage these young people to stick to healthier eating and exercise habits. The goal is to help them lose weight and improve their insulin sensitivity, reducing their risk of developing type 2 diabetes and other health issues related to obesity.

To be eligible for this trial, participants should be between 10 and 16 years old, overweight or obese, and diagnosed with impaired glucose tolerance. They should also be going through puberty. The study is currently recruiting participants, and those who join will wear a CGM for the duration of the trial. This device will track their glucose levels continuously, allowing the researchers to see how it affects their lifestyle changes. Importantly, kids with type 1 or type 2 diabetes, or those who are not willing to wear the CGM, cannot participate. Overall, this trial aims to find effective ways to prevent diabetes in young people through better monitoring and lifestyle changes.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Children 10 to \<17 years old (i.e., before their 17th birthday)
• • 2. Impaired glucose tolerance based on standardized oral glucose tolerance test (OGTT) or fasting glucose per American Diabetes Association criteria,
• • 3. Overweight or obese (BMI ≥85th percentile for age/sex)
• • 4. Patients are pubertal, defined as females with breast Tanner stage II or above, or males with testicular volume ≥4 mL
• Exclusion Criteria:
• • 1. Existing diagnosis of type 1 or type 2 diabetes
• • 2. Prepubertal
• • 3. Taking medications that affect insulin sensitivity (e.g.,chronic corticosteroids whether systemic or inhaled). Metformin allowed if stable dose.
• • 4. Patients and/or families not willing to wear the CGM for the duration of the study period or lack of compliance after recruitment