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

Description

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.

Conditions

Diabetes Mellitus, Type 2, Diabetes Mellitus, Type 1, Gastroparesis with Diabetes Mellitus

Study Overview

Study Details

Study overview

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.

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

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

Condition
Diabetes Mellitus, Type 2
Intervention / Treatment

-

Contacts and Locations

Cleveland

Cleveland Clinic Foundation, Cleveland, Ohio, United States, 44195

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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.
  • * 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.

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Samita Garg,

Samita Garg, MD, PRINCIPAL_INVESTIGATOR, The Cleveland Clinic

Study Record Dates

2025-03