A Study Comparing Continuous Glucose Monitoring Augmented Nutritional Counseling and Standard of Care Treatment Strategies in a Three-Month Nutrition Intervention
14. juli 2026 opdateret af: University of Florida
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.
Studieoversigt
Status
Ikke rekrutterer endnu
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
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.
Undersøgelsestype
Interventionel
Tilmelding (Anslået)
100
Fase
- Ikke anvendelig
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiekontakt
- Navn: Angelina Bernier, MD
- Telefonnummer: 508-558-0475
- E-mail: angelina@ufl.edu
Undersøgelse Kontakt Backup
- Navn: Salvatore Anzalone, MD
- Telefonnummer: 610-587-1010
- E-mail: sanzalone@healthcareswfl.org
Studiesteder
-
-
Florida
-
Gainesville, Florida, Forenede Stater, 32610
- University of Florida
-
Kontakt:
- Angelina Bernier, MD
- Telefonnummer: 508-558-0475
- E-mail: angelina@ufl.edu
-
Kontakt:
- Jenifer Hosford, MPH
- Telefonnummer: 352-294-5759
- E-mail: jennifer.hosford@peds.ufl.edu
-
Underforsker:
- Shivani Berry, MD
-
-
Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
- Barn
Tager imod sunde frivillige
Ingen
Beskrivelse
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.
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Forebyggelse
- Tildeling: Randomiseret
- Interventionel model: Sekventiel tildeling
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Aktiv komparator: Open CGM use
Use of a continuous glucose monitor where the patient can see all of their blood glucose data
|
Open use of CGM device where patients can see their blood glucose values.
|
|
Ingen indgriben: No CGM Use
Standard of care treatment with no CGM use
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Total caloric intake
Tidsramme: Baseline; 3 Months
|
Total caloric intake as assessed from a validated 24-hour Dietary Recall
|
Baseline; 3 Months
|
|
Total grams of carbohydrates from sugar
Tidsramme: Baseline; 3 Months
|
Total grams of carbohydrates from sugar in food as assessed from a validated 24-hour Dietary Recall
|
Baseline; 3 Months
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
5-point Likert scale Questionnaire of child food understanding
Tidsramme: Baseline; 3 Months
|
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
Tidsramme: Baseline; 3 Months
|
Difference in Hba1c, tested per standard of care
|
Baseline; 3 Months
|
|
Metabolic outcome - Difference in BMI Z score
Tidsramme: Baseline; 3 Months
|
Difference in BMI Z score, per standard of care
|
Baseline; 3 Months
|
|
Metabolic outcome - Difference in complete metabolic panel
Tidsramme: Baseline; 3 Months
|
Difference in complete metabolic panel between baseline and 3 months, per standard of care
|
Baseline; 3 Months
|
|
Differences in Fitness assessment scores
Tidsramme: Baseline; 3 Months
|
Difference in Fitness Assessment scores using an already published fitness assessment testing battery given to each patient
|
Baseline; 3 Months
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Anslået)
1. august 2026
Primær færdiggørelse (Anslået)
1. august 2027
Studieafslutning (Anslået)
1. august 2028
Datoer for studieregistrering
Først indsendt
8. juli 2026
Først indsendt, der opfyldte QC-kriterier
14. juli 2026
Først opslået (Faktiske)
20. juli 2026
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
20. juli 2026
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
14. juli 2026
Sidst verificeret
1. juli 2026
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- IRB202600180
- AGR00036900 (Andet bevillings-/finansieringsnummer: NCEF)
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
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Ingen
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Ja
produkt fremstillet i og eksporteret fra U.S.A.
Ingen
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