Using continuous glucose monitors to help kids with impaired glucose tolerance improve their health
Effect of Adding Continuous Glucose Monitoring (CGM) to Lifestyle Changes on Insulin Sensitivity in Patients With Impaired Glucose Tolerance
This study tests if using continuous glucose monitors can help kids with impaired glucose tolerance make healthier choices to improve their health and lower their risk of type 2 diabetes.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 15 (estimated) |
| Ages | 10 Years to 18 Years |
| Sex | All |
| Sponsor | Nemours Children's Clinic Academic / other |
| Locations | 1 site (Jacksonville, Florida) |
| Trial ID | NCT05387551 on ClinicalTrials.gov |
What this trial studies
This research evaluates the effectiveness of continuous glucose monitors (CGM) in aiding lifestyle modifications for children and adolescents with impaired glucose tolerance. By providing real-time blood sugar data, the study aims to enhance adherence to healthier lifestyle choices, potentially leading to weight loss and improved insulin sensitivity. Participants will wear a CGM device that tracks their glucose levels, which may help them make better dietary and activity choices. The ultimate goal is to reduce the risk of developing type 2 diabetes and other obesity-related complications.
Who should consider this trial
Good fit: Ideal candidates are children aged 10 to 16 years who are overweight or obese and have impaired glucose tolerance.
Not a fit: Patients with existing diagnoses of type 1 or type 2 diabetes or those who are prepubertal may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly lower the risk of type 2 diabetes and related health issues in children and adolescents.
How similar studies have performed: Other studies have shown promise in using continuous glucose monitoring for lifestyle interventions, suggesting potential success for this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Children 10 to \<18 years old (i.e., before their 18th 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
Where this trial is running
Jacksonville, Florida
- Nemours Children's Clinic — Jacksonville, Florida, United States (Recruiting)
Study contacts
- Principal investigator: Larry A Fox, MD — Nemours Children's Health
- Study coordinator: Larry Fox, MD
- Email: larry.fox@nemours.org
- Phone: 9046973674
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.