Status:
RECRUITING
Continuous Glucose Metrics in Patients With Gastroparesis in Type 1 or Type 2 Diabetes
Lead Sponsor:
Samita Garg
Conditions:
Diabetes Mellitus, Type 2
Diabetes Mellitus, Type 1
Eligibility:
All Genders
18+ years
Phase:
NA
Brief 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 w...
Detailed Description
Investigators will analyze and compare various Glucose Metrics (GM) derived from a Continuous Glucose Monitor (CGM) between individuals with diabetes and gastroparesis and those with diabetes without ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
January 8 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 1 2026
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT06046833
Start Date
January 8 2024
End Date
March 1 2026
Last Update
April 25 2025
Active Locations (1)
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1
Cleveland Clinic Foundation
Cleveland, Ohio, United States, 44195