[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT07714759":3,"trial-entities:NCT07714759":126,"trial-summary:NCT07714759":133},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":6,"overall_status":7,"completion_date":8,"status_verified_date":9,"last_update_date":10,"start_date":11,"sponsor_name":12,"lead_sponsor_class":13,"has_dmc":14,"brief_summary":15,"detailed_description":16,"conditions":17,"keywords":21,"study_type":26,"primary_purpose":27,"phases":28,"enrollment_info":30,"interventions":33,"primary_outcomes":40,"secondary_outcomes":48,"sex":64,"minimum_age":65,"maximum_age":66,"healthy_volunteers":14,"eligibility_criteria":67,"std_ages":93,"locations":95,"central_contacts":117,"overall_officials":123,"references":124,"see_also_links":125},"NCT07714759","IRB202600180","A Study Comparing Continuous Glucose Monitoring Augmented Nutritional Counseling and Standard of Care Treatment Strategies in a Three-Month Nutrition Intervention","NOT_YET_RECRUITING","2028-08","2026-07","2026-07-20","2026-08","University of Florida","OTHER",false,"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.","Building on prior UF protocols and national ORBIT-model guidance for early-phase behavioral-treatment development, this study represents a Phase I\u002FIIa 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.",[18,19,20],"Obesity & Overweight","Obese Adolescents","Metabolic Abnormalities",[22,23,24,25],"continuous glucose monitor","obesity","overweight","Metabolic abnormality","INTERVENTIONAL","PREVENTION",[29],"NA",{"count":31,"type":32},100,"ESTIMATED",[34],{"type":35,"name":36,"description":37,"armGroupLabels":38},"DEVICE","Use of an unblinded CGM device","Open use of CGM device where patients can see their blood glucose values.",[39],"Open CGM use",[41,45],{"measure":42,"description":43,"timeFrame":44},"Total caloric intake","Total caloric intake as assessed from a validated 24-hour Dietary Recall","Baseline; 3 Months",{"measure":46,"description":47,"timeFrame":44},"Total grams of carbohydrates from sugar","Total grams of carbohydrates from sugar in food as assessed from a validated 24-hour Dietary Recall",[49,52,55,58,61],{"measure":50,"description":51,"timeFrame":44},"5-point Likert scale Questionnaire of child food understanding","Results from a questionnaire assessing the child's understanding of food on a 5-point likert scale",{"measure":53,"description":54,"timeFrame":44},"Metabolic outcome - Difference in Hba1c","Difference in Hba1c, tested per standard of care",{"measure":56,"description":57,"timeFrame":44},"Metabolic outcome - Difference in BMI Z score","Difference in BMI Z score, per standard of care",{"measure":59,"description":60,"timeFrame":44},"Metabolic outcome - Difference in complete metabolic panel","Difference in complete metabolic panel between baseline and 3 months, per standard of care",{"measure":62,"description":63,"timeFrame":44},"Differences in Fitness assessment scores","Difference in Fitness Assessment scores using an already published fitness assessment testing battery given to each patient","ALL","13 Years","17 Years",{"inclusion":68,"exclusion":80,"raw_text":92},[69,70,71,72,73,74,75,76,77,78,79],"Children aged 13-17 years.","BMI ≥ 95 percentile","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:","Race\u002Fethnicity 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\u002Fguardian 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.",[81,82,83,84,85,86,87,88,89,90,91],"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:","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.","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.",[94],"CHILD",[96],{"facility":12,"city":97,"state":98,"zip":99,"country":100,"contacts":101,"geoPoint":114},"Gainesville","Florida","32610","United States",[102,107,111],{"name":103,"role":104,"phone":105,"email":106},"Angelina Bernier, MD","CONTACT","508-558-0475","angelina@ufl.edu",{"name":108,"role":104,"phone":109,"email":110},"Jenifer Hosford, MPH","352-294-5759","jennifer.hosford@peds.ufl.edu",{"name":112,"role":113},"Shivani Berry, MD","SUB_INVESTIGATOR",{"lat":115,"lon":116},29.65163,-82.32483,[118,119],{"name":103,"role":104,"phone":105,"email":106},{"name":120,"role":104,"phone":121,"email":122},"Salvatore Anzalone, MD","610-587-1010","sanzalone@healthcareswfl.org",[],[],[],{"nct_id":4,"conditions":127,"biomarkers":131},[128,129,130],"Obesity","Overweight","Prediabetes",[132],"Hemoglobin A1C Measurement",{"nct_id":4,"found":134,"summary":135,"prompt_version":145},true,{"design":136,"status":137,"heading":138,"summary":139,"follow_up":140,"word_count":141,"commitments":142,"compensation":143,"drugs_mentioned":144},"This is an interventional study comparing two groups: one using a CGM device and one not. It is a feasibility and signal-of-efficacy trial, with 100 participants planned.","completed","Continuous Glucose Monitoring for Adolescents with Obesity","This study is looking at whether using a Continuous Glucose Monitor (CGM) can help teenagers with obesity and pre-diabetes (blood sugar levels higher than normal, but not yet diabetes) make healthier food choices. You would be between 13 and 17 years old and have a high Body Mass Index (BMI). Some participants will use an unblinded CGM device, which means they can see their blood sugar levels in real-time. The study aims to see if this awareness changes eating habits and blood sugar profiles. Researchers will measure your total calorie intake and the amount of sugar you eat at the beginning and after three months to see if the intervention is successful. The current recruitment status is unclear, and the study plans to enroll 100 participants.","Your total caloric intake and total grams of carbohydrates from sugar will be measured at the beginning and after 3 months.",126,"Not specified in the trial record.","Not stated in the trial record.",[],"v2"]