RecruitingNot ApplicableNCT06046833

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

Sponsor

Samita Garg

Enrollment

50 participants

Start Date

Jan 8, 2024

Study Type

INTERVENTIONAL

Conditions

Diabetes Mellitus, Type 2 Diabetes Mellitus, Type 1 Gastroparesis With Diabetes Mellitus

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

Min Age: 18 Years

Inclusion Criteria8

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 Criteria15

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.