The objective of this project is to determine the feasibility of introducing CGMs to adolescent patients with obesity and pre-diabetes (Hemoglobin A1C: HbA1C between 5.7-6.5%) to determine whether their eating habits and subsequent glucose profiles are modified by the timely awareness of glucose excursions above the diabetes threshold of 200 mg/dl.
Children aged 13-17 years.
BMI ≥ 95 percentile
Race/ethnicity Native American, African American, Latino, Asian American, Pacific Islander
Signs of insulin resistance or conditions associated with insulin resistance (acanthosis nigricans, hypertension, dyslipidemia, polycystic ovary syndrome, or small-for-gestational-age birth weight)
Diabetes by history or HbA1c ≥ 6.5 % in the medical record or at screening.
Unable or unwilling to provide consent or participate fully in study activities.
Conditions predisposing to diabetes or altering normal pubertal development.
Known syndromic or monogenic obesity.
Sequential
Use of an unblinded CGM device
DeviceOpen use of CGM device where patients can see their blood glucose values.
Total caloric intake
Total caloric intake as assessed from a validated 24-hour Dietary Recall
Total grams of carbohydrates from sugar
Total grams of carbohydrates from sugar in food as assessed from a validated 24-hour Dietary Recall
5-point Likert scale Questionnaire of child food understanding
Results from a questionnaire assessing the child's understanding of food on a 5-point likert scale
Metabolic outcome - Difference in Hba1c
Difference in Hba1c, tested per standard of care
Metabolic outcome - Difference in BMI Z score
Difference in BMI Z score, per standard of care
Metabolic outcome - Difference in complete metabolic panel
Difference in complete metabolic panel between baseline and 3 months, per standard of care
Click on the lead sponsor to view all of their trials.
University of Florida
Lead sponsor
Healthcare Network
Collaborator
Collier County Health Services
Collaborator
This trial is not recruiting at the moment. You can still explore other options:
