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

Part of paid clinical trials in Cleveland, Ohio.

Sponsor
Samita Garg
Study ID
NCT06046833
Status
Recruiting

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • FreeStyle Libre 3 continuous glucose monitoring sensor — DEVICE
    The Freestyle Libre 3 sensor is a small real-time continuous glucose monitor device that measures glucose levels every minute
  • Nutritional drink — OTHER
    Balanced nutritional drink (Boost plus 8 ounces/237 mL)

Study Details

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.

Key Dates

Start date
Jan 8, 2024
Status verified
Apr 2025
Primary completion
Mar 31, 2026
Completion
Mar 31, 2026

Study Design

Enrollment
50 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SCREENING

Arms

  • 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

Primary Outcome Measure

Time-in-Range (TIR) [ Time Frame: 28 days of monitoring ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Cleveland Clinic FoundationClevelandOhio44195
Samita Garg, MD
216-444-2384
Jorge Araujo-Duran, MD
216-444-7935

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