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
- Are there results?
- Not yet: the study is under way
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
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study Comparing Continuous Glucose Monitoring Augmented Nutritional Counseling and Standard of Care Treatment Strategies in a Three-Month Nutrition Intervention
- ClinicalTrials.gov ID
- NCT07714759
- Acronym / sponsor ID
- IRB202600180
- Keywords
- continuous glucose monitor, obesity, overweight, Metabolic abnormality
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University of FloridaUniversity, hospital or other
- Collaborators
- Healthcare Network, Collier County Health Services
- Study start
- Aug 2026 (estimated)
- Primary completion
- Aug 2027 (estimated)
- Study completion
- Aug 2028 (estimated)
- First posted
- 20 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Open CGM use | Active comparator | Device: Use of an unblinded CGM deviceUse of a continuous glucose monitor where the patient can see all of their blood glucose data |
| No CGM Use | No intervention | –Standard of care treatment with no CGM use |
Who may qualify
- Ages
- 13 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (11 listed)
- 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:
- Receiving care through HCN for pediatric or family medicine clinics.
- No structured nutritional intervention in the past 3 months.
Key exclusion criteria (13 listed)
- 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:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Use of an unblinded CGM deviceOpen use of CGM device where patients can see their blood glucose values. | Device | Open CGM use |
Primary outcome
Total caloric intake
Time frame: Baseline; 3 Months
Total caloric intake as assessed from a validated 24-hour Dietary Recall
Total grams of carbohydrates from sugar
Time frame: Baseline; 3 Months
Total grams of carbohydrates from sugar in food as assessed from a validated 24-hour Dietary Recall
5 secondary outcomes
5-point Likert scale Questionnaire of child food understanding
Time frame: Baseline; 3 Months
Metabolic outcome - Difference in Hba1c
Time frame: Baseline; 3 Months
Metabolic outcome - Difference in BMI Z score
Time frame: Baseline; 3 Months
Metabolic outcome - Difference in complete metabolic panel
Time frame: Baseline; 3 Months
Differences in Fitness assessment scores
Time frame: Baseline; 3 Months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jul 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
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.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 20 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Angelina Bernier, MD (508-558-0475, angelina@ufl.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total caloric intake (time frame: Baseline; 3 Months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jul 2026.