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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
13 Years to 17 Years
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This 3-month study compares food counseling with a continuous glucose monitor (CGM) to usual care. A CGM tracks blood sugar throughout the day. The study is for teens ages 13–17 with obesity and prediabetes, and tests whether seeing high blood sugar readings helps change their eating habits and blood sugar levels.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Age 13–17.
  • Body mass index (BMI), a measure of weight for height, at or above the 95th percentile for age and sex; or above the 85th and below the 95th percentile with the listed risk factors.
  • Risk factors for the lower BMI range include type 2 diabetes in a close relative; Native American, African American, Latino, Asian American, or Pacific Islander background; or a mother who had diabetes during the pregnancy.
  • Other listed risk factors include signs that the body does not use insulin well: dark, thick skin patches, high blood pressure, unhealthy blood fat levels, polycystic ovary syndrome (a hormone condition), or low birth weight for the length of pregnancy.
  • Receive care at an HCN children's or family medicine clinic, with no structured food counseling program in the past 3 months.
  • A parent or guardian can give permission, and the child can agree to join.
  • Family has a smartphone or will use a study device to view CGM readings and communicate.
  • Willing to attend study visits, wear the CGM, and have lab tests.

Who can't join

  • History of diabetes, or an HbA1c of 6.5% or higher in medical records or at screening. HbA1c measures average blood sugar.
  • Unable or unwilling to give permission or fully take part; or speaks neither English nor Spanish, the languages used for study surveys.
  • A condition that raises diabetes risk or changes normal puberty; or obesity caused by a known genetic condition.
  • Current or planned use of medicines that affect blood sugar. This includes insulin, GLP-1 medicines, metformin, or other blood sugar or weight-loss medicines within 6 weeks before joining or during the study.
  • A blood disorder, such as anemia or an unusual form of hemoglobin, that affects HbA1c results; or major kidney, liver, or heart disease.
  • Past or planned weight-loss surgery.
  • Pregnant or planning pregnancy during the study.
  • Current or planned use of GnRH agonists (medicines that block certain hormones), estrogen, or testosterone.

Simplified for readability. The official criteria below are what the study team uses.

Official 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.

Study sites (1)

FL