A Study Comparing Continuous Glucose Monitoring Augmented Nutritional Counseling and Standard of Care Treatment Strategies in a Three-Month Nutrition Intervention

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age13-17
SponsorUniversity of Florida

About this trial

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.

Eligibility criteria

Qualifiers

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)

Disqualifiers

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.

Trial design

Treatments tested in this trial

  • Use of an unblinded CGM device

Treatment groups

100 Participants
are divided into 2 treatment groups

Sponsors and collaborators

University of Florida

Lead sponsor

Healthcare Network

Collaborator

Collier County Health Services

Collaborator