Opening soonNot applicableInterventional
What this study is about
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.
A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.
Basic eligibility
Age13 Years to 17 Years
SexAll
Healthy volunteersNot accepted
ConditionObesity & Overweight, Obese Adolescents, Metabolic Abnormalities
Full registry 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.