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Glucose Sensors With Nutrition Counseling for Teens With Obesity and Pre-Diabetes

Tests a continuous glucose monitor with nutrition counseling in teens with obesity and pre-diabetes.

Key facts

Who runs it
University of Florida
Where
Gainesville, United StatesSee the site
Trial code
Registry title
A Study Comparing Continuous Glucose Monitoring Augmented Nutritional Counseling and Standard of Care Treatment Strategies in a Three-Month Nutrition Intervention
Status
Not yet recruiting
People taking part
100 people, planned
Started
Aug 2026
Expected to end
Aug 2028
Type of study
Interventional, 2 groupsOne group gets an existing treatment, for comparison.
Treatments tested
  • Use of an unblinded CGM device
Record updated
20 July 2026

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for teenagers aged 13-17 with obesity and pre-diabetes. It tests whether a glucose sensor (CGM) with nutrition counseling changes eating habits over three months.

Age
13 to 17 years.
Sex
All sexes can join.
Disease stage
BMI at or above the 95th percentile; or BMI above the 85th and below the 95th percentile with certain risk factors (for example family history of type 2 diabetes, insulin resistance signs). HbA1c between 5.7-6.5% (39–48 mmol/mol) is the pre-diabetes range in the summary.
Earlier treatment
No structured nutritional intervention in the past 3 months. No insulin, GLP-1 receptor agonists, metformin or other glucose-lowering or weight-loss medicines within 6 weeks before enrollment.
Biomarker or test result
HbA1c below 6.5% (48 mmol/mol); the summary describes pre-diabetes as HbA1c between 5.7-6.5% (39–48 mmol/mol).

Main reasons for not taking part

  • Diabetes, or HbA1c of 6.5% (48 mmol/mol) or higher
  • Known syndromic or monogenic obesity
  • Blood disorders that affect HbA1c readings, such as anemia
  • Major kidney, liver or heart disease, or bariatric surgery
  • Current pregnancy or plans for pregnancy during the study

The registry criteria, word for word

Show all 20 criteriaShow less

Who can take part

  • 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

Who cannot take part

  • History or planned bariatric surgery
  • Conditions predisposing to diabetes or altering normal pubertal development
  • Major systemic organ disease (renal, hepatic, or cardiac)
  • 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)
  • 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

Check if you might fit

Answer for yourself. This is not a decision: only the study team can say whether you can take part.

  • Are you between 13 and 17 years old?

Where in United States

  • University of FloridaGainesville, United StatesContact: Angelina Bernier, MDNot yet recruiting

About the trial

What the trial wants to find out

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.

The 2 groups in the trial

  • Open CGM useExisting treatment, for comparison

    Use of a continuous glucose monitor where the patient can see all of their blood glucose data

    Treatment: Use of an unblinded CGM device

  • No CGM UseNo study treatment, for comparison

    Standard of care treatment with no CGM use

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov.
Official title
A Study Comparing Continuous Glucose Monitoring Augmented Nutritional Counseling and Standard of Care Treatment Strategies in a Three-Month Nutrition Intervention
Plain-language title
Glucose Sensors With Nutrition Counseling for Teens With Obesity and Pre-DiabetesGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 13 November 2026.
Fit questions
Built from NCT07714759, who can take part
Record updated
20 July 2026