CGM and Lifestyle Changes in Patients With Impaired Glucose Tolerance
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age10-18
SponsorNemours Children's Clinic
About this trial
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.
Eligibility criteria
Qualifiers
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
Disqualifiers
Existing diagnosis of type 1 or type 2 diabetes
Prepubertal
Taking medications that affect insulin sensitivity (e.g.,chronic corticosteroids whether systemic or inhaled). Metformin allowed if stable dose.
Patients and/or families not willing to wear the CGM for the duration of the study period or lack of compliance after recruitment
Trial design
Treatments tested in this trial
- CGM
Treatment groups
15 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov