Recruiting
Continuous Glucose Metrics in Patients With Gastroparesis in Type 1 or Type 2 Diabetes
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.
ClinicalTrials.gov IDNCT06046833
PhaseNA
Enrollment50
SponsorSamita Garg
Age18 Years
SexALL
Conditions studied
Diabetes Mellitus, Type 2, Diabetes Mellitus, Type 1, Gastroparesis With Diabetes Mellitus
About this study
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.
Interventions
- Device: FreeStyle Libre 3 continuous glucose monitoring sensor — The Freestyle Libre 3 sensor is a small real-time continuous glucose monitor device that measures glucose levels every minute
- Other: Nutritional drink — Balanced nutritional drink (Boost plus 8 ounces/237 mL)
Primary outcomes
- Time-in-Range (TIR) (28 days of monitoring)
- Time-in-Tight Range (TITR) (28 days of monitoring)
- Time Below Range (TBR) (28 days of monitoring)
- Time Above Range (TAR) (28 days of monitoring)
- Metrics of Glucose Variability (28 days of monitoring)
Eligibility information
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.
Study locations
- Cleveland Clinic Foundation, Cleveland, Ohio 44195 United States
Before you participate: Varda Clinical is an independent discovery tool, not the study sponsor or a medical provider. Eligibility can only be determined by the official study team. Discuss potential risks and benefits with a qualified healthcare professional.
Source: ClinicalTrials.gov. Record last refreshed by Varda Clinical: 2026-09-29.