Continuous Glucose Metrics in Patients With Gastroparesis in Type 1 or Type 2 Diabetes
Diabetes Mellitus, Type 2, Diabetes Mellitus, Type 1, Gastroparesis With Diabetes Mellitus
About this trial
This is an interventional screening trial for Diabetes Mellitus, Type 2 focused on measuring Gastroparesis, Diabetes, Continuous Glucose Monitor
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 3 months 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. Presence of celiac disease. 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.
Sites / Locations
- Cleveland Clinic Foundation
Arms of the Study
Arm 1
Arm 2
Experimental
Active Comparator
Patients with type 1 or type 2 diabetes and gastroparesis
Patients with type 1 or type 2 diabetes without gastroparesis
Both groups will have the same intervention. FreeStyle Libre 3 sensor for Continuous Glucose Monitoring. Balanced nutritional drink (Boost plus 8 ounces/237 mL) for a standardized meal challenge.
Both groups will have the same intervention. FreeStyle Libre 3 sensor for Continuous Glucose Monitoring. Balanced nutritional drink (Boost plus 8 ounces/237 mL) for a standardized meal challenge