NCT06046833

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

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
• Phase: N/A
• Study type: Interventional
• Enrollment: 50 (estimated)
• Sponsor: Samita Garg · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Investigators will analyze and compare various Glucose Metrics (GM) derived from a Continuous Glucose Monitor (CGM) between individuals with diabetes and gastroparesis and those with diabetes without gastroparesis over a period of 28 days and during two standardized meal challenge visits. Furthermore, the investigators aim to assess whether there is an association between gastroparesis and GM parameters. 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

• Diabetes Mellitus, Type 2
• Diabetes Mellitus, Type 1
• Gastroparesis With Diabetes Mellitus

Interventions

Type	Name	Description
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)

Timeline

• Start date: 2024-01-08
• Primary completion: 2026-03-01
• Completion: 2026-03-01
• First posted: 2023-09-21
• Last updated: 2025-04-25

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study