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

Status: Recruiting
Location: See location...
Intervention Type: Other, Device
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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.

Locations
United States
Ohio
Cleveland Clinic Foundation
RECRUITING
Cleveland
Contact Information
Primary
Samita Garg, MD
gargs@ccf.org
216-444-2384
Backup
Jorge Araujo-Duran, MD
araujoj@ccf.org
216-444-7935
Time Frame
Start Date: 2024-01-08
Estimated Completion Date: 2026-03
Participants
Target number of participants: 50
Treatments
Experimental: 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.
Active_comparator: 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
Sponsors
Leads: Samita Garg

This content was sourced from clinicaltrials.gov