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RECRUITING
NCT06764069
NA

Feasibility Study to Evaluate an Intravascular Blood Continuous Glucose Sensor

Sponsor: Glucotrack

View on ClinicalTrials.gov

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

Interventions

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.

Locations (1)

Instituto do Coração (InCor) |

São Paulo, Brazil, Brazil