NCT06764069

Feasibility Study to Evaluate an Intravascular Blood Continuous Glucose Sensor

Early Feasibility Study to Evaluate an Intravascular Blood Continuous Glucose Sensor in Adults with Diabetes Mellitus

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 10 (estimated)
• Sponsor: Glucotrack · Industry
• Sex: All
• Age: 21 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

The goal of this early first in man clinical trial is to evaluate the safety of an implantable continuous blood glucose monitoring system in participants with Diabetes Mellitus. Safety will be assessed by looking at the absence of procedure or device related adverse events. Additionally, the surgical procedure and device performance will be evaluated. Key Research Questions: 1. Were there any adverse events associated with the insertion of the Sensor Lead? 2. Did Participants experience any device-related adverse events from the Sensor Lead insertion through the 96-hour observation period and subsequent removal of the Sensor Lead? 3. How effectively did the device capture data during the 96-hour wear period?

Detailed description

Eligible Participants will be inserted with the Sensor Lead of the investigational continuous blood glucose monitoring device and stay in the hospital for a 96-hour observation period. Glucose measurements, medications and food will be tracked throughout the 96-hour Observation period. Two 3-hour frequent sample tests (sampling every 15-min for glucose measurement) will occur during the 96-hour Observation period. After approximately 96-hours is complete the participant will have the Sensor Lead removed and will be discharged after an hour observation post removal. A final follow-up visit will occur approximately 1-week post sensor removal to check on the removal site and formally exit that participant from the study. All safety events will be recorded.

Conditions

• Diabetes Mellitus

Interventions

Type	Name	Description
DEVICE	Sensor Lead	The Glucotrack Sensor Lead will be inserted into the subclavian vein, using a Seldinger technique, where it will continuously measure blood glucose levels.

Timeline

• Start date: 2024-12-13
• Primary completion: 2025-02-04
• Completion: 2025-02-28
• First posted: 2025-01-08
• Last updated: 2025-01-08

Locations

1 site across 1 country: Brazil

Regulatory

• FDA-regulated device study