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

NCT07714759

Not Yet RecruitingNA

Sponsor: University of Florida

Conditions: Obesity & Overweight, Obese Adolescents, Metabolic Abnormalities

Interventions: Use of an unblinded CGM device

Countries: United States

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 overview

Sex: ALL

Age: 13 Years to 17 Years

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria

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.

Locations (1)

Gainesville, Florida, United States