[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Samita Garg\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":45},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,1,0,[8],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":29,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":34,"lastUpdatePostDateStruct":35,"startDateStruct":38,"completionDateStruct":40,"leadSponsor":42,"locationsCount":5},"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":19,"type":20},50,"ESTIMATED","INTERVENTIONAL",[23],"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.",[26,27,28],"Diabetes Mellitus, Type 2","Diabetes Mellitus, Type 1","Gastroparesis With Diabetes Mellitus",[30,31,32],"Gastroparesis","Diabetes","Continuous Glucose Monitor","RECRUITING","2025-04-23",{"date":36,"type":37},"2025-04-25","ACTUAL",{"date":39,"type":37},"2024-01-08",{"date":41,"type":20},"2026-03",{"name":43,"class":44},"Samita Garg","OTHER",""]