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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Obesity & Overweight; Metabolic Abnormalities; Obese Adolescents
• Intervention / Treatment: Device: Use of an unblinded CGM device

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 Type: Interventional
• Enrollment (Estimated): 100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Angelina Bernier, MD; Phone Number: 508-558-0475; Email: angelina@ufl.edu
• Study Contact Backup: Name: Salvatore Anzalone, MD; Phone Number: 610-587-1010; Email: sanzalone@healthcareswfl.org

Study Locations

• United States
  • Florida
    • Gainesville, Florida, United States, 32610
      • University of Florida
      • Contact: Angelina Bernier, MD; Phone Number: 508-558-0475; Email: angelina@ufl.edu
      • Contact: Jenifer Hosford, MPH; Phone Number: 352-294-5759; Email: jennifer.hosford@peds.ufl.edu
      • Sub-Investigator: Shivani Berry, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Open CGM use; Use of a continuous glucose monitor where the patient can see all of their blood glucose data	Device: Use of an unblinded CGM device; Open use of CGM device where patients can see their blood glucose values.
No Intervention: No CGM Use; Standard of care treatment with no CGM use

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Total caloric intake	Total caloric intake as assessed from a validated 24-hour Dietary Recall	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	Baseline; 3 Months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	Baseline; 3 Months
Metabolic outcome - Difference in Hba1c	Difference in Hba1c, tested per standard of care	Baseline; 3 Months
Metabolic outcome - Difference in BMI Z score	Difference in BMI Z score, per standard of care	Baseline; 3 Months
Metabolic outcome - Difference in complete metabolic panel	Difference in complete metabolic panel between baseline and 3 months, per standard of care	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	Baseline; 3 Months

Collaborators and Investigators

• Sponsor: University of Florida
• Collaborators: Healthcare Network; Collier County Health Services

Study record dates

Study Major Dates

• Study Start (Estimated): August 1, 2026
• Primary Completion (Estimated): August 1, 2027
• Study Completion (Estimated): August 1, 2028

Study Registration Dates

• First Submitted: July 8, 2026
• First Submitted That Met QC Criteria: July 14, 2026
• First Posted (Actual): July 20, 2026

Study Record Updates

• Last Update Posted (Actual): July 20, 2026
• Last Update Submitted That Met QC Criteria: July 14, 2026
• Last Verified: July 1, 2026

More Information

Terms related to this study

• Keywords: obesity; overweight; continuous glucose monitor; Metabolic abnormality
• Additional Relevant MeSH Terms: Nutrition Disorders; Overnutrition; Body Weight; Pathological Conditions, Signs and Symptoms; Nutritional and Metabolic Diseases; Signs and Symptoms; Overweight; Obesity
• Other Study ID Numbers: IRB202600180; AGR00036900 (Other Grant/Funding Number: NCEF)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No