Early Feasibility Study to Evaluate an Intravascular Blood Continuous Glucose Sensor in Adults with Diabetes Mellitus
Sponsor study identifier
interventional
10
1 country
1
Study Start
December 13, 2024
Actual (reported)Primary Completion
February 4, 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
February 28, 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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:
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
February 28, 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
December 13, 2024
Actual (reported)December 13, 2024
Actual (reported)January 8, 2025
Actual (reported)February 4, 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
February 28, 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Primary outcome: study device safety as evidence by absence of serious procedure or device related adverse event(s).
No procedure or device related serious adverse events from implant through the 7 days post-explant appointment.
From enrollment through 7-days (+/-3 days) post Sensor Lead removal.
One Glucotrack Sensor Lead will be inserted per Participant.
The Glucotrack Sensor Lead will be inserted into the subclavian vein, using a Seldinger technique, where it will continuously measure blood glucose levels.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Instituto do Coração (InCor) |
São Paulo, Brazil, 05403-000, Brazil
First Submitted
December 13, 2024
First Posted
January 8, 2025
Study Start
December 13, 2024
Actual (reported)Primary Completion
Contact the study team to confirm eligibility.
February 4, 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
February 28, 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
January 8, 2025
Record last verified: 2024-12
Participants will be identified by a participant ID only. Data that may be provided includes demographic data, as well as glucose results from the investigational and supporting commercial devices.
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Source: ClinicalTrials.gov.
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