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Feasibility Study to Evaluate an Intravascular Blood Continuous Glucose Sensor

NCT06764069 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2025-01-08

No results posted yet for this study

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?

Conditions

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.

Sponsors & Collaborators

  • Glucotrack

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
OTHER
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
21 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-12-13
Primary Completion
2025-02-04
Completion
2025-02-28
FDA Device
Yes

Countries

  • Brazil

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06764069 on ClinicalTrials.gov