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Continuous Glucose Metrics in Patients With Gastroparesis in Type 1 or Type 2 Diabetes
Recruiting
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
Who can join
Ages 18 and older · All sexes
Full eligibility criteria
Inclusion Criteria: * Over the age of 18 years. * Hemoglobin A1c ≤11% within the last 6 months. * Patients with diagnosis of type 1 Diabetes or type 2 Diabetes for at least one year. * Normal thyroid-stimulating hormone (TSH) within the last year. * No episodes of diabetic ketoacidosis (DKA), Hyperosmolar Hyperglycemic Status (HHS), or hypoglycemia in the past 2 weeks requiring ER visit or hospitalization. * Symptoms of gastroparesis have been present for at least the past 3 months, in patients with gastroparesis. * In patients with gastroparesis, documented delayed gastric emptying on scintigraphy and/or 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. * Patients using a Smartphone (iPhone or Android) compatible with LibreView App. Exclusion Criteria: * Hemoglobin A1c of \>11% at enrollment. * Advanced chronic kidney disease (serum creatinine of \>2 mg/dL or estimated glomerular filtration rate (eGFR) \<30mL/min/1.73m² using Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) formula). * Advanced and significant cardiovascular disease or unstable angina. * Advanced liver disease that may affect glucose profiles. * Post-transplant patients. * History of gastric surgery. * Patients with symptoms secondary to celiac disease (e.g. diarrhea, nausea, vomiting, abdominal pain) at the time of the enrollment. * Pregnancy or women of reproductive age group not taking adequate precautions for pregnancy for 28 days. * Patients on steroids or immunomodulators or chemoradiation that might affect glucose profiles. * 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. * Patient on recreational or illicit drugs (i.e., marijuana, opiates, cocaine, etc.). * 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. * Clinically significant abnormalities on upper GI endoscopy. * Presence of imaging evidence of gastric or intestinal obstruction. * Patient previously participated in the study.
About the study
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.
What is being tested
- FreeStyle Libre 3 continuous glucose monitoring sensor (device)
- Nutritional drink (other)
Sponsor: Samita Garg · Participants: 50 · Started: Jan 8, 2024
Contact the study team
- Samita Garg, MD · Phone: 216-444-2384
- Jorge Araujo-Duran, MD · Phone: 216-444-7935
Official record on ClinicalTrials.gov — NCT06046833
Locations in the U.S.
| Ohio | Cleveland Clinic Foundation, Cleveland |
Conditions
From ClinicalTrials.gov, data retrieved Sep 29, 2026. Each study sets its own eligibility; the study team decides who can join.