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

NCT07714759 | Not Yet Recruiting FDA Device

• 2 other identifiers: IRB202600180AGR00036900
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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 diabetes threshold of 200 mg/dl.

Conditions

Obesity & Overweight; Obese Adolescents; Metabolic Abnormalities

Keywords

continuous glucose monitor; obesity; overweight; Metabolic abnormality

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (5)

• 5-point Likert scale Questionnaire of child food understanding

  Baseline; 3 Months

• Metabolic outcome - Difference in Hba1c

  Baseline; 3 Months

• Metabolic outcome - Difference in BMI Z score

  Baseline; 3 Months

• Metabolic outcome - Difference in complete metabolic panel

  Baseline; 3 Months

• Differences in Fitness assessment scores

  Baseline; 3 Months

Study Arms (2)

Open CGM use

ACTIVE COMPARATOR

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

Device: Use of an unblinded CGM device

No CGM Use

NO INTERVENTION

Standard of care treatment with no CGM use

Interventions

Use of an unblinded CGM device DEVICE

Open use of CGM device where patients can see their blood glucose values.

Open CGM use

Eligibility Criteria

• Age: 13 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Florida: lead
• Healthcare Network: collaborator
• Collier County Health Services: collaborator

Study Sites (1)

University of Florida

Gainesville, Florida, 32610, United States

Location

MeSH Terms

Conditions

Obesity; Overweight

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Angelina Bernier, MD

CONTACT

508-558-0475; angelina@ufl.edu

Salvatore Anzalone, MD

CONTACT

610-587-1010; sanzalone@healthcareswfl.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 8, 2026
• First Posted: July 20, 2026
• Study Start: August 1, 2026
• Primary Completion (Estimated): August 1, 2027
• Study Completion (Estimated): August 1, 2028
• Last Updated: July 20, 2026

Record last verified: 2026-07

Locations

US (1)