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Not yet recruiting NCT07714759

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

No phase Interventional Obesity & Overweight Obese Adolescents Metabolic Abnormalities

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Use of an unblinded CGM device.
Who it may be relevant to
Registry conditions: Obesity & Overweight, Obese Adolescents, Metabolic Abnormalities. Basic parameters: 13 years — 17 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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.

Interventions

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

Primary outcome measures

  • Total caloric intake [Time frame: Baseline; 3 Months]
  • Total grams of carbohydrates from sugar [Time frame: Baseline; 3 Months]
Secondary outcome measures (5)
  • 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]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Sequential
Masking
Open label
Primary purpose
Prevention

Study locations

United States · 1 center
  • University of Florida — Gainesville

Identifiers

NCT: NCT07714759 · IRB202600180 · AGR00036900

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗