NCT07714759Not yet recruiting
A Study Comparing Continuous Glucose Monitoring Augmented Nutritional Counseling and Standard of Care Treatment Strategies in a Three-Month Nutrition Intervention
Source: ClinicalTrials.gov · Last updated 20 Jul 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Study type
- Interventional
- Enrollment
- 100 (estimated)
- First submitted
- 8 Jul 2026
- Start date
- 1 Aug 2026
- Primary completion date
- 31 Aug 2027
- Lead sponsor
- University of Florida
- Diseases
- Obesity
- NCT number
- NCT07714759
What you commit to
- Study type: Interventional
- Planned participants: 100
- From 1 Aug 2026 to the primary completion date, 31 Aug 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- History or planned bariatric surgery.
Other illness
- Conditions predisposing to diabetes or altering normal pubertal development.
- Major systemic organ disease (renal, hepatic, or cardiac).
Lab values
- Diabetes by history or HbA1c ≥ 6.5 % in the medical record or at screening.
- 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.
- Blood disorders that impact HbA1c interpretation (e.g., anemia, and hemoglobin variants).
Other
- An individual who meets any of the following criteria will be excluded from participation:
- Unable or unwilling to provide consent or participate fully in study activities.
- Known syndromic or monogenic obesity.
- 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.
Who the study is looking for
- 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.
Age in the registry: 13 years to 17 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University of Florida Coordinator of this site? Confirm its status | Gainesville | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.