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

N/ANot Yet RecruitingNCT07714759

University of Florida100 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Enrollment

100

Conditions

Obesity & Overweight Obese Adolescents Metabolic Abnormalities

Eligibility

Sex: ALLMin age: 13 YearsMax age: 17 Years

Medical Language ↔ Plain English

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.