Evaluating glucose metrics in diabetes patients with and without gastroparesis
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
This study is testing how glucose levels change in people with diabetes who have gastroparesis compared to those who don’t, using a continuous glucose monitor to help spot early signs of gastroparesis.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 50 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | The Cleveland Clinic Academic / other |
| Locations | 1 site (Cleveland, Ohio) |
| Trial ID | NCT06046833 on ClinicalTrials.gov |
What this trial studies
This pilot study aims to evaluate and compare glucose metrics using a real-time continuous glucose monitor (FreeStyle Libre 3 sensor) in patients with diabetes who have gastroparesis versus those who do not. Over a 28-day period, participants will undergo two standardized meal challenges while their glucose metrics are monitored. The study seeks to develop a new tool, the Diabetic Gastroparesis Index, to help identify early signs of gastroparesis in diabetic patients. Additionally, the study will assess the relationship between glucose metrics and symptoms of gastroparesis using validated questionnaires.
Who should consider this trial
Good fit: Ideal candidates include adults over 18 with type 1 or type 2 diabetes and symptoms of gastroparesis for at least three months.
Not a fit: Patients with advanced chronic kidney disease or those with poorly controlled diabetes (A1c >11%) may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to earlier recognition and management of gastroparesis in diabetic patients, improving their overall health outcomes.
How similar studies have performed: While this approach is innovative, similar studies have shown promise in using continuous glucose monitoring for diabetes management, but the specific focus on gastroparesis is less explored.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Cleveland, Ohio
- Cleveland Clinic Foundation — Cleveland, Ohio, United States (Recruiting)
Study contacts
- Principal investigator: Samita Garg, MD — The Cleveland Clinic
- Study coordinator: Samita Garg, MD
- Email: gargs@ccf.org
- Phone: 216-444-2384
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.