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
This trial does not accept healthy volunteersQualifiers
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
Design model
Single group
Treatments tested in this trial
CGM
DeviceDexcom G7 sensor, transmitter and supplies will be provided to family for use. Participants will wear G7 and have real-time glucose data throughout the study.
Treatment groups
15 Participants
are divided into 1 treatment groupGroup A: CGM interventionExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Insulin Sensitivity Score (ISS)
Change in insulin sensitivity as measured by insulin sensitivity Score (ISS). The ISS directly correlates with insulin sensitivity. Higher scores indicate higher insulin sensitivity; lower scores indicate more insulin resistance.
Time frame
Baseline to 6 monthsSecondary outcomes
1
QUICKI insulin sensitivity
Change in insulin sensitivity as measured by QUICKI
Time frame
Baseline to 3 months2
QUICKI insulin sensitivity
Change in insulin sensitivity as measured by QUICKI
Time frame
Baseline to 6 months3
Insulin Sensitivity Score
Change in insulin sensitivity as measured by insulin sensitivity Score (ISS). The ISS directly correlates with insulin sensitivity. Higher scores indicate higher insulin sensitivity; lower scores indicate more insulin resistance.
Time frame
Baseline to 3 months4
Glycemic levels
Change in characteristics of glycemic levels obtained from the CGM data. This will include: * mean, standard deviation of glucose levels * time in range (glucose between 70-140 mg/dL) * percent of time with hyperglycemia (\>140 mg/dL) * percent of time with hypoglycemia (\<70 mg/dL)
Time frame
Baseline to 3 and 6 monthsSponsors and contacts
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Source ClinicalTrials.gov