NCT06046833 Continuous Glucose Metrics in Patients With Gastroparesis in Type 1 or Type 2 Diabetes
| NCT ID | NCT06046833 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Samita Garg |
| Condition | Diabetes Mellitus, Type 2 |
| Study Type | INTERVENTIONAL |
| Enrollment | 50 participants |
| Start Date | 2024-01-08 |
| Primary Completion | 2026-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 50 participants in total. It began in 2024-01-08 with a primary completion date of 2026-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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 without gastroparesis.
Eligibility Criteria
Inclusion 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. Exclusion Criteria: * 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.
Contact & Investigator
Samita Garg, MD
PRINCIPAL INVESTIGATOR
The Cleveland Clinic
Frequently Asked Questions
Who can join the NCT06046833 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Diabetes Mellitus, Type 2. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06046833 currently recruiting?
Yes, NCT06046833 is actively recruiting participants. Contact the research team at gargs@ccf.org for enrollment information.
Where is the NCT06046833 trial being conducted?
This trial is being conducted at Cleveland, United States.
Who is sponsoring the NCT06046833 clinical trial?
NCT06046833 is sponsored by Samita Garg. The principal investigator is Samita Garg, MD at The Cleveland Clinic. The trial plans to enroll 50 participants.
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