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NCT06046833Recruiting

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

Source: ClinicalTrials.gov · Last updated 3 Aug 2026

Brief summary (registry, in English)

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.

Status (registry)
Recruiting
Study type
Interventional
Enrollment
50 (estimated)
First submitted
6 Sept 2023
Start date
8 Jan 2024
Primary completion date
Dec 2026
Lead sponsor
Samita Garg
NCT number
NCT06046833

What you commit to

  • Study type: Interventional
  • Planned participants: 50
  • From 8 Jan 2024 to the primary completion date, Dec 2026
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Post-transplant patients.
  • 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.
  • Patient previously participated in the study.

Other illness

  • Advanced and significant cardiovascular disease or unstable angina.
  • History of gastric surgery.
  • Patients with symptoms secondary to celiac disease (e.g. diarrhea, nausea, vomiting, abdominal pain) at the time of the enrollment.

Lab values

  • 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 liver disease that may affect glucose profiles.
  • Patients on steroids or immunomodulators or chemoradiation that might affect glucose profiles.

Age

  • Pregnancy or women of reproductive age group not taking adequate precautions for pregnancy for 28 days.

Other

  • Clinically significant abnormalities on upper GI endoscopy.
  • Presence of imaging evidence of gastric or intestinal obstruction.

Who the study is looking for

  • 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.

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Cleveland Clinic Foundation
Coordinator of this site? Confirm its status
ClevelandUnited StatesRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.