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

Building on prior UF protocols and national ORBIT-model guidance for early-phase behavioral-treatment development, this study represents a Phase I/IIa feasibility and signal-of-efficacy trial. The study is a comparison of food choice and decision making between a NO CGM group and a Open-label CGM group. Several bio markers are used to determine the consequences of nutritional choices. This information is used in nutritional counselling sessions.

Inclusion criteria

• Children aged 13-17 years.
• BMI ≥ 95 percentile
• BMI >85th and BMI < 95th percentile for age and sex (CDC growth charts) if the risk factors below are present: Family history of type 2 diabetes in first or second degree relative:

• 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)
• Maternal history of diabetes or gestational diabetes mellitus (GDM) during the child's gestation
• Receiving care through HCN for pediatric or family medicine clinics.
• No structured nutritional intervention in the past 3 months.
• Parent/guardian able to provide informed consent and child able to assent.
• Family has access to a smartphone or is willing to use a study-provided device for CGM viewing and communication.
• Willingness to comply with study visits, CGM wear, and laboratory testing.

Exclusion criteria

An individual who meets any of the following criteria will be excluded from participation:

• 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.
• Current or planned use of medications affecting glucose dynamics, including:

o Insulin, glucagon-like peptide-1 (GLP-1) receptor agonists, metformin, or other glucose-lowering or weight-loss medications within 6 weeks prior to enrollment or planned during the study period.

• Known syndromic or monogenic obesity.
• Blood disorders that impact HbA1c interpretation (e.g., anemia, and hemoglobin variants).
• Major systemic organ disease (renal, hepatic, or cardiac).
• History or planned bariatric surgery.
• Current pregnancy or plans for pregnancy during the study.
• Use or planned use of GnRH agonists, estrogen, or testosterone.
• Non-English- or non-Spanish-speaking individuals, as validated questionnaires are available only in these languages.