Clinical trial

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

Opening soon · Not applicable · 1 countries · Registry ID NCT07714759

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.

Treatments and study arms

Use of an unblinded CGM device

Device

Open use of CGM device where patients can see their blood glucose values.

Primary outcomes

Total caloric intakeBaseline; 3 Months

Total caloric intake as assessed from a validated 24-hour Dietary Recall

Total grams of carbohydrates from sugarBaseline; 3 Months

Total grams of carbohydrates from sugar in food as assessed from a validated 24-hour Dietary Recall

Study locations

1 locations were listed when this page was built. The first 40 are shown.

University of Florida🇺🇸 Gainesville, Florida, United States
Angelina Bernier, MDContact
Jenifer Hosford, MPHContact
Shivani Berry, MDSub Investigator