[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100519690":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":34,"centralContacts":38,"locations":48,"responsibleParty":66,"collaborators":42,"id":70,"slug":71,"hasResults":72,"nctId":73,"briefTitle":74,"officialTitle":75,"acronym":42,"eligibilityCriteria":76,"healthyVolunteers":72,"sex":77,"minAge":78,"maxAge":42,"enrollmentInfo":79,"targetDuration":42,"studyType":82,"phases":83,"briefSummary":85,"conditions":86,"keywords":90,"overallStatus":51,"whyStopped":42,"lastUpdateSubmitDate":94,"lastUpdatePostDateStruct":95,"startDateStruct":98,"completionDateStruct":100,"leadSponsor":102,"locationsCount":103},{"fullName":5,"class":6},"The Cleveland Clinic","OTHER",[8,15],{"label":9,"type":10,"description":11,"interventionNames":12},"Patients with type 1 or type 2 diabetes and gastroparesis","EXPERIMENTAL","Both groups will have the same intervention.\n\n* FreeStyle Libre 3 sensor for Continuous Glucose Monitoring.\n* Balanced nutritional drink (Boost plus 8 ounces\u002F237 mL) for a standardized meal challenge.",[13,14],"Device: FreeStyle Libre 3 continuous glucose monitoring sensor","Other: Nutritional drink",{"label":16,"type":17,"description":18,"interventionNames":19},"Patients with type 1 or type 2 diabetes without gastroparesis","ACTIVE_COMPARATOR","Both groups will have the same intervention.\n\n* FreeStyle Libre 3 sensor for Continuous Glucose Monitoring.\n* Balanced nutritional drink (Boost plus 8 ounces\u002F237 mL) for a standardized meal challenge",[13,14],[21,28],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DEVICE","FreeStyle Libre 3 continuous glucose monitoring sensor","The Freestyle Libre 3 sensor is a small real-time continuous glucose monitor device that measures glucose levels every minute",[9,16],[27],"FreeStyle Libre 3 system",{"type":6,"name":29,"description":30,"armGroupLabels":31,"otherNames":32},"Nutritional drink","Balanced nutritional drink (Boost plus 8 ounces\u002F237 mL)",[9,16],[33],"Boost plus",[35],{"name":36,"affiliation":5,"role":37},"Samita Garg, MD","PRINCIPAL_INVESTIGATOR",[39,44],{"name":36,"role":40,"phone":41,"phoneExt":42,"email":43},"CONTACT","216-444-2384",null,"gargs@ccf.org",{"name":45,"role":40,"phone":46,"phoneExt":42,"email":47},"Jorge Araujo-Duran, MD","216-444-7935","araujoj@ccf.org",[49],{"facility":50,"status":51,"city":52,"state":53,"zip":54,"country":55,"countryCode":56,"cosmosGeoPoint":57,"geoPoint":62,"contacts":63},"Cleveland Clinic Foundation","RECRUITING","Cleveland","Ohio","44195","United States","US",{"type":58,"coordinates":59},"Point",[60,61],-81.69541,41.4995,{"lat":61,"lon":60},[64,65],{"name":36,"role":40,"phone":41,"phoneExt":42,"email":43},{"name":45,"role":40,"phone":46,"phoneExt":42,"email":47},{"type":67,"investigatorFullName":68,"investigatorTitle":69,"investigatorAffiliation":5,"oldNameTitle":42,"oldOrganization":42},"SPONSOR_INVESTIGATOR","Samita Garg","Principal Investigator","100519690","continuous-glucose-metrics-in-patients-with-gastroparesis-in-type-1-or-type-2-diabetes-100519690",false,"NCT06046833","Continuous Glucose Metrics in Patients With Gastroparesis in Type 1 or Type 2 Diabetes","Glucose Metrics Using Freestyle Libre 3 Real-Time Continuous Glucose Monitor (rtCGM) in Patients With Gastroparesis in Type 1 or Type 2 Diabetes: Investigator Initiated Pilot Study","Inclusion Criteria:\n\n* Over the age of 18 years.\n* Hemoglobin A1c ≤11% within the last 6 months.\n* Patients with diagnosis of type 1 Diabetes or type 2 Diabetes for at least one year.\n* Normal thyroid-stimulating hormone (TSH) within the last year.\n* No episodes of diabetic ketoacidosis (DKA), Hyperosmolar Hyperglycemic Status (HHS), or hypoglycemia in the past 2 weeks requiring ER visit or hospitalization.\n* Symptoms of gastroparesis have been present for at least the past 3 months, in patients with gastroparesis.\n* In patients with gastroparesis, documented delayed gastric emptying on scintigraphy and\u002For wireless motility capsule (Smart Pill) as defined by greater than 10% retention at 4 hours or greater than 4-hour gastric transit time (GTT) in the past five years.\n* Patients using a Smartphone (iPhone or Android) compatible with LibreView App.\n\nExclusion Criteria:\n\n* Hemoglobin A1c of \\>11% at enrollment.\n* Advanced chronic kidney disease (serum creatinine of \\>2 mg\u002FdL or estimated glomerular filtration rate (eGFR) \\\u003C30mL\u002Fmin\u002F1.73m² using Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) formula).\n* Advanced and significant cardiovascular disease or unstable angina.\n* Advanced liver disease that may affect glucose profiles.\n* Post-transplant patients.\n* History of gastric surgery.\n* Patients with symptoms secondary to celiac disease (e.g. diarrhea, nausea, vomiting, abdominal pain) at the time of the enrollment.\n* Pregnancy or women of reproductive age group not taking adequate precautions for pregnancy for 28 days.\n* Patients on steroids or immunomodulators or chemoradiation that might affect glucose profiles.\n* Patients on opiates or glucagon-like peptide-1 (GLP-1) agonists (Ozempic, Wegovy, Mounjaro, Trulicity). If previously taking these medications, patients can be enrolled after 2 weeks of the last dose.\n* Patient on recreational or illicit drugs (i.e., marijuana, opiates, cocaine, etc.).\n* Patients on motility medications such as Reglan (Metoclopramide), Motegrity (Prucalopride), Cisapride, Domperidone, Erythromycin. If previously taking any of these medications, patients can be enrolled after 1 week of the last dose.\n* Clinically significant abnormalities on upper GI endoscopy.\n* Presence of imaging evidence of gastric or intestinal obstruction.\n* Patient previously participated in the study.","ALL","18 Years",{"count":80,"type":81},50,"ESTIMATED","INTERVENTIONAL",[84],"NA","A pilot study to evaluate and compare glucose metrics using a real-time continuous glucose monitor (FreeStyle Libre 3 sensor) between patients with diabetes and gastroparesis and those with diabetes without gastroparesis.",[87,88,89],"Diabetes Mellitus, Type 2","Diabetes Mellitus, Type 1","Gastroparesis With Diabetes Mellitus",[91,92,93],"Gastroparesis","Diabetes","Continuous Glucose Monitor","2025-04-23",{"date":96,"type":97},"2025-04-25","ACTUAL",{"date":99,"type":97},"2024-01-08",{"date":101,"type":81},"2026-03",{"name":68,"class":6},1]