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

Part of paid clinical trials in Gainesville, Florida.

Sponsor
University of Florida
Study ID
NCT07714759
Status
Not Yet Recruiting

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Conditions

  • Metabolic Abnormalities
  • Obese Adolescents
  • Obesity & Overweight

Eligibility Criteria

Sex
ALL
Age
13 Years - 17 Years
Healthy Volunteers
Not accepted

Interventions

  • Use of an unblinded CGM device — DEVICE
    Open use of CGM device where patients can see their blood glucose values.

Study Details

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.

Key Dates

First listed
Jul 20, 2026
Start date
Aug 31, 2026
Status verified
Jul 2026
Primary completion
Aug 31, 2027
Completion
Aug 31, 2028

Study Design

Enrollment
100 participants (estimated)
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
PREVENTION

Arms

  • Active Comparator: Open CGM use
    Use of a continuous glucose monitor where the patient can see all of their blood glucose data
  • No Intervention: No CGM Use
    Standard of care treatment with no CGM use

Primary Outcome Measure

Total caloric intake [ Time Frame: Baseline; 3 Months ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of FloridaGainesvilleFlorida32610
Angelina Bernier, MD
[email protected]
508-558-0475
Jenifer Hosford, MPH
[email protected]
352-294-5759
Shivani Berry, MD (SUB_INVESTIGATOR)

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By research site
University of Florida· Gainesville, FL

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