RECRUITING

Continuous Glucose Metrics in Patients with Gastroparesis in Type 1 or Type 2 Diabetes

Conditions

Diabetes Mellitus, Type 2 Diabetes Mellitus, Type 1 Gastroparesis with Diabetes Mellitus Gastroparesis Diabetes Continuous Glucose Monitor

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2024-01-08

Study Completion:2025-03

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06046833

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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.	* 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.

Inclusion Criteria

Exclusion 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.

* 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.

Contacts and Locations

Study Contact

Samita Garg, MD

CONTACT

216-444-2384

gargs@ccf.org

Jorge Araujo-Duran, MD

CONTACT

216-444-7935

araujoj@ccf.org

Principal Investigator

Samita Garg, MD

PRINCIPAL_INVESTIGATOR

The Cleveland Clinic

Study Locations (Sites)

Cleveland Clinic Foundation

Cleveland, Ohio, 44195

United States

Collaborators and Investigators

Sponsor: Samita Garg

Samita Garg, MD, PRINCIPAL_INVESTIGATOR, The Cleveland Clinic

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-01-08

Study Completion Date2025-03

Study Record Updates

Study Start Date2024-01-08

Study Completion Date2025-03

Terms related to this study

Keywords Provided by Researchers

Gastroparesis
Diabetes
Continuous Glucose Monitor

Additional Relevant MeSH Terms

Diabetes Mellitus, Type 2
Diabetes Mellitus, Type 1
Gastroparesis with Diabetes Mellitus