Continuous Glucose Metrics in Patients With Gastroparesis in Type 1 or Type 2 Diabetes

Recruiting now · Not applicable

Conditions studied: Diabetes Mellitus, Type 2, Diabetes Mellitus, Type 1, Gastroparesis With Diabetes Mellitus

In brief

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.

Key facts

Study ID

NCT06046833

Run by

Samita Garg

People needed

50

Starts

2024-01-08

Expected to finish

2026-12-01

Last updated by the study team

2026-08-03

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Cleveland Clinic Foundation — Cleveland, Ohio, United States (enrolling)

Full record on ClinicalTrials.gov

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