NCT05387551Completed
CGM and Lifestyle Changes in Patients With Impaired Glucose Tolerance
Effect of Adding Continuous Glucose Monitoring (CGM) to Lifestyle Changes on Insulin Sensitivity in Patients With Impaired Glucose Tolerance
Source: ClinicalTrials.gov · Last updated 7 Aug 2026
Brief summary (registry, in English)
The incidence of type 2 diabetes (T2D) in children is increasing, paralleling the rising incidence of obesity. Preventing children and adolescents from developing T2D is critical. The health benefits of lifestyle modifications are well documented in this population, but success rates are low. Obesity in children and adolescents increases the risk of not only T2D but other complications as well, such as hypertension, dyslipidemias and more. The investigators hypothesize that having real-time glucose data with the use of a continuous glucose monitor (CGM) in obese patients with impaired glucose tolerance will improve adherence to lifestyle modifications. As a result, a decrease in body mass index (BMI) is expected with subsequent improvement in insulin sensitivity, thus reducing risk of obesity-related complications later in childhood/adolescence and adulthood.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 12 (actual)
- First submitted
- 16 May 2022
- Start date
- 1 Dec 2022
- Primary completion date
- 25 Jun 2026
- Lead sponsor
- Nemours Children's Clinic
- Diseases
- Obesity
- NCT number
- NCT05387551
What you commit to
- Study type: Interventional
- Participants enrolled: 12
- From 1 Dec 2022 to the primary completion date, 25 Jun 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Taking medications that affect insulin sensitivity (e.g.,chronic corticosteroids whether systemic or inhaled). Metformin allowed if stable dose.
Other illness
- Existing diagnosis of type 1 or type 2 diabetes
Other
- Prepubertal
- Patients and/or families not willing to wear the CGM for the duration of the study period or lack of compliance after recruitment
Who the study is looking for
- Children 10 to \<18 years old (i.e., before their 18th birthday)
- Impaired glucose tolerance based on standardized oral glucose tolerance test (OGTT) or fasting glucose per American Diabetes Association criteria,
- Overweight or obese (BMI ≥85th percentile for age/sex)
- Patients are pubertal, defined as females with breast Tanner stage II or above, or males with testicular volume ≥4 mL
Age in the registry: 10 years to 18 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Nemours Children's Clinic Coordinator of this site? Confirm its status | Jacksonville | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.