[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100647953":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":18,"centralContacts":25,"locations":35,"responsibleParty":57,"collaborators":59,"id":65,"slug":66,"hasResults":67,"nctId":68,"briefTitle":69,"officialTitle":69,"acronym":18,"eligibilityCriteria":70,"healthyVolunteers":67,"sex":71,"minAge":72,"maxAge":73,"enrollmentInfo":74,"targetDuration":18,"studyType":77,"phases":78,"briefSummary":80,"conditions":81,"keywords":85,"overallStatus":90,"whyStopped":18,"lastUpdateSubmitDate":91,"lastUpdatePostDateStruct":92,"startDateStruct":95,"completionDateStruct":97,"leadSponsor":99,"locationsCount":100},{"fullName":5,"class":6},"University of Florida","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Open CGM use","ACTIVE_COMPARATOR","Use of a continuous glucose monitor where the patient can see all of their blood glucose data",[13],"Device: Use of an unblinded CGM device",{"label":15,"type":16,"description":17,"interventionNames":18},"No CGM Use","NO_INTERVENTION","Standard of care treatment with no CGM use",null,[20],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":18},"DEVICE","Use of an unblinded CGM device","Open use of CGM device where patients can see their blood glucose values.",[9],[26,31],{"name":27,"role":28,"phone":29,"phoneExt":18,"email":30},"Angelina Bernier, MD","CONTACT","508-558-0475","angelina@ufl.edu",{"name":32,"role":28,"phone":33,"phoneExt":18,"email":34},"Salvatore Anzalone, MD","610-587-1010","sanzalone@healthcareswfl.org",[36],{"facility":5,"status":18,"city":37,"state":38,"zip":39,"country":40,"countryCode":41,"cosmosGeoPoint":42,"geoPoint":47,"contacts":48},"Gainesville","Florida","32610","United States","US",{"type":43,"coordinates":44},"Point",[45,46],-82.32483,29.65163,{"lat":46,"lon":45},[49,50,54],{"name":27,"role":28,"phone":29,"phoneExt":18,"email":30},{"name":51,"role":28,"phone":52,"phoneExt":18,"email":53},"Jenifer Hosford, MPH","352-294-5759","jennifer.hosford@peds.ufl.edu",{"name":55,"role":56,"phone":18,"phoneExt":18,"email":18},"Shivani Berry, MD","SUB_INVESTIGATOR",{"type":58,"investigatorFullName":18,"investigatorTitle":18,"investigatorAffiliation":18,"oldNameTitle":18,"oldOrganization":18},"SPONSOR",[60,63],{"name":61,"class":62},"Healthcare Network","UNKNOWN",{"name":64,"class":62},"Collier County Health Services","100647953","a-study-comparing-continuous-glucose-monitoring-augmented-nutritional-counseling-and-standard-of-care-treatment-strategies-in-a-three-month-nutrition-intervention-100647953",false,"NCT07714759","A Study Comparing Continuous Glucose Monitoring Augmented Nutritional Counseling and Standard of Care Treatment Strategies in a Three-Month Nutrition Intervention","Inclusion Criteria:\n\n* Children aged 13-17 years.\n* BMI ≥ 95 percentile\n* BMI \\>85th and BMI \\\u003C 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:\n\n  * Race\u002Fethnicity Native American, African American, Latino, Asian American, Pacific Islander\n  * Signs of insulin resistance or conditions associated with insulin resistance (acanthosis nigricans, hypertension, dyslipidemia, polycystic ovary syndrome, or small-for-gestational-age birth weight)\n  * Maternal history of diabetes or gestational diabetes mellitus (GDM) during the child's gestation\n* Receiving care through HCN for pediatric or family medicine clinics.\n* No structured nutritional intervention in the past 3 months.\n* Parent\u002Fguardian able to provide informed consent and child able to assent.\n* Family has access to a smartphone or is willing to use a study-provided device for CGM viewing and communication.\n* Willingness to comply with study visits, CGM wear, and laboratory testing.\n\nExclusion Criteria:\n\nAn individual who meets any of the following criteria will be excluded from participation:\n\n* Diabetes by history or HbA1c ≥ 6.5 % in the medical record or at screening.\n* Unable or unwilling to provide consent or participate fully in study activities.\n* Conditions predisposing to diabetes or altering normal pubertal development.\n* Current or planned use of medications affecting glucose dynamics, including:\n\n  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.\n* Known syndromic or monogenic obesity.\n* Blood disorders that impact HbA1c interpretation (e.g., anemia, and hemoglobin variants).\n* Major systemic organ disease (renal, hepatic, or cardiac).\n* History or planned bariatric surgery.\n* Current pregnancy or plans for pregnancy during the study.\n* Use or planned use of GnRH agonists, estrogen, or testosterone.\n* Non-English- or non-Spanish-speaking individuals, as validated questionnaires are available only in these languages.","ALL","13 Years","17 Years",{"count":75,"type":76},100,"ESTIMATED","INTERVENTIONAL",[79],"NA","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\u002Fdl.",[82,83,84],"Obesity & Overweight","Obese Adolescents","Metabolic Abnormalities",[86,87,88,89],"continuous glucose monitor","obesity","overweight","Metabolic abnormality","NOT_YET_RECRUITING","2026-07-14",{"date":93,"type":94},"2026-07-20","ACTUAL",{"date":96,"type":76},"2026-08",{"date":98,"type":76},"2028-08",{"name":5,"class":6},1]