Obesity & OverweightNCT07714759
A Study Comparing Continuous Glucose Monitoring Augmented Nutritional Counseling and Standard of Care Treatment Strategies in a Three-Month Nutrition Intervention
A study testing Use of an unblinded CGM device in people with Obesity & Overweight and Obese Adolescents, run by University of Florida at 1 site in United States.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 13 to 17 years
- Conditions the study is for
- Obesity & Overweight, Obese Adolescents, Metabolic Abnormalities
- What is being tested?
- Use of an unblinded CGM device
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2026to Aug 2028
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 13 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
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- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
University of Florida
Gainesville, Florida, 32610
Angelina Bernier, MD, 508-558-0475, angelina@ufl.edu
Jenifer Hosford, MPH, 352-294-5759, jennifer.hosford@peds.ufl.edu
About this study
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.
Read the detailed description
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.
- Being tested
- Use of an unblinded CGM device
- Keywords
- continuous glucose monitor, obesity, overweight, Metabolic abnormality
- Medical subject headings
- Obesity, Overweight
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Use of an unblinded CGM deviceDevice
Open use of CGM device where patients can see their blood glucose values.
| Study group | Role | What they receive |
|---|---|---|
| Open CGM use | Active comparator | Use of a continuous glucose monitor where the patient can see all of their blood glucose data Receives: Device: Use of an unblinded CGM device |
| No CGM Use | No intervention | Standard of care treatment with no CGM use |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total caloric intake
Total caloric intake as assessed from a validated 24-hour Dietary Recall
Measured: Baseline; 3 Months
Total grams of carbohydrates from sugar
Total grams of carbohydrates from sugar in food as assessed from a validated 24-hour Dietary Recall
Measured: Baseline; 3 Months
Secondary outcomes (5)
5-point Likert scale Questionnaire of child food understanding
Results from a questionnaire assessing the child's understanding of food on a 5-point likert scale
Measured: Baseline; 3 Months
Metabolic outcome - Difference in Hba1c
Difference in Hba1c, tested per standard of care
Measured: Baseline; 3 Months
Metabolic outcome - Difference in BMI Z score
Difference in BMI Z score, per standard of care
Measured: Baseline; 3 Months
Metabolic outcome - Difference in complete metabolic panel
Difference in complete metabolic panel between baseline and 3 months, per standard of care
Measured: Baseline; 3 Months
Differences in Fitness assessment scores
Difference in Fitness Assessment scores using an already published fitness assessment testing battery given to each patient
Measured: Baseline; 3 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2026
- Study startAug 2026 (estimated)
- Primary completionAug 2027 (estimated)
- Study completionAug 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obesity & OverweightStudies of the same condition, open and under way.
- More trials run by University of FloridaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Florida
- Sponsor type
- University, hospital or other
- Collaborators
- Healthcare Network, Collier County Health Services
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07714759
- Sponsor's protocol ID
- IRB202600180
- Other IDs
- AGR00036900
- Status last verified
- Jul 2026
- First submitted
- 8 Jul 2026
- Last updated
- 20 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes