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

Summary

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.

Eligibility

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.

Conditions4

Locations1 site

Browse More Trials