Continuous Glucose Metrics in Patients With Gastroparesis in Type 1 or Type 2 Diabetes
NCT ID: NCT06046833
Last Updated: 2025-04-25
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
50 participants
INTERVENTIONAL
2024-01-08
2026-03-31
Brief Summary
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Detailed Description
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The objective is to propose a new tool (Diabetic Gastroparesis Index or Score) to assess for early gastroparesis in patients with diabetes using the identified and analyzed GM. This may help patients and providers to recognize gastroparesis early and facilitate necessary medical interventions.
Hyperglycemia and hypoglycemia episodes will be monitored throughout the study for both groups and their association with GM and gastroparesis will be evaluated.
The Gastroparesis Cardinal Symptom Index (GCSI) and the Gastrointestinal Quality of Life Index (GIQLI) questionnaires will be performed to assess the association of gastroparesis symptoms with GM.
Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
SCREENING
NONE
Study Groups
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Patients with type 1 or type 2 diabetes and gastroparesis
Both groups will have the same intervention.
* FreeStyle Libre 3 sensor for Continuous Glucose Monitoring.
* Balanced nutritional drink (Boost plus 8 ounces/237 mL) for a standardized meal challenge.
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
Nutritional drink
Balanced nutritional drink (Boost plus 8 ounces/237 mL)
Patients with type 1 or type 2 diabetes without gastroparesis
Both groups will have the same intervention.
* FreeStyle Libre 3 sensor for Continuous Glucose Monitoring.
* Balanced nutritional drink (Boost plus 8 ounces/237 mL) for a standardized meal challenge
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
Nutritional drink
Balanced nutritional drink (Boost plus 8 ounces/237 mL)
Interventions
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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
Nutritional drink
Balanced nutritional drink (Boost plus 8 ounces/237 mL)
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
ALL
No
Sponsors
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Samita Garg
OTHER
Responsible Party
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Samita Garg
Principal Investigator
Principal Investigators
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Samita Garg, MD
Role: PRINCIPAL_INVESTIGATOR
The Cleveland Clinic
Locations
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Cleveland Clinic Foundation
Cleveland, Ohio, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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23-594
Identifier Type: -
Identifier Source: org_study_id
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