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

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About this study

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.

Condition
Diabetes Mellitus, Type 2, Diabetes Mellitus, Type 1, Gastroparesis With Diabetes Mellitus
Tested
FreeStyle Libre 3 continuous glucose monitoring sensor, Nutritional drink
Sponsor
Samita Garg

Who can join

Age
18 years and older
Sex
All sexes
Healthy volunteers
Not accepted

Inclusion 10

  • Minimum age: 18 years
  • Study condition: Diabetes Mellitus, Type 2, Diabetes Mellitus, Type 1, Gastroparesis With Diabetes Mellitus
  • 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 15

  • 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

1 site, 1 recruiting

Cleveland Clinic Foundation

Cleveland, Ohio, United States

Recruiting

Contact

Potential match only. Final eligibility is determined by the study team.