Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
NCT06046833

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

Led by Samita Garg · Updated on 2025-04-25

50

Participants Needed

1

Research Sites

111 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

Official Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Over the age of 18 years.
  • Hemoglobin A1c 6411% within the last 6 months.
  • Diagnosis of type 1 or type 2 diabetes for at least one year.
  • Normal thyroid-stimulating hormone (TSH) within the last year.
  • No episodes of diabetic ketoacidosis, hyperosmolar hyperglycemic status, or hypoglycemia requiring emergency room visit or hospitalization in the past 2 weeks.
  • Symptoms of gastroparesis present for at least the past 3 months, if applicable.
  • Documented delayed gastric emptying on scintigraphy or wireless motility capsule within the past five years for patients with gastroparesis.
  • Use of a smartphone compatible with the LibreView App (iPhone or Android).
Not Eligible

You will not qualify if you...

  • Hemoglobin A1c greater than 11% at enrollment.
  • Advanced chronic kidney disease (serum creatinine >2 mg/dL or eGFR <30 mL/min/1.73m).
  • Advanced or significant cardiovascular disease or unstable angina.
  • Advanced liver disease affecting glucose profiles.
  • Post-transplant patients.
  • History of gastric surgery.
  • Symptoms due to celiac disease at enrollment.
  • Pregnancy or women of reproductive age not using adequate pregnancy precautions for 28 days.
  • Use of steroids, immunomodulators, or chemoradiation affecting glucose profiles.
  • Use of opiates or GLP-1 agonists unless stopped at least 2 weeks before enrollment.
  • Use of recreational or illicit drugs.
  • Use of motility medications unless stopped at least 1 week before enrollment.
  • Clinically significant abnormalities on upper GI endoscopy.
  • Imaging evidence of gastric or intestinal obstruction.
  • Previous participation in this study.

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Cleveland Clinic Foundation

Cleveland, Ohio, United States, 44195

Actively Recruiting

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Research Team

S

Samita Garg, MD

CONTACT

J

Jorge Araujo-Duran, MD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NON_RANDOMIZED

Model

PARALLEL

Primary Purpose

SCREENING

Number of Arms

2

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