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Feasibility Study to Evaluate an Intravascular Blood Continuous Glucose Sensor
Sponsor: Glucotrack
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?
Official title: Early Feasibility Study to Evaluate an Intravascular Blood Continuous Glucose Sensor in Adults with Diabetes Mellitus
Key Details
Gender
All
Age Range
21 Years - 75 Years
Study Type
INTERVENTIONAL
Enrollment
10
Start Date
2024-12-13
Completion Date
2025-02-28
Last Updated
2025-01-08
Healthy Volunteers
No
Conditions
Interventions
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.
Locations (1)
Instituto do Coração (InCor) |
São Paulo, Brazil, Brazil