Ignite Creation Date:
2025-12-24 @ 11:04 PM
Ignite Modification Date:
2026-01-01 @ 8:26 PM
Study NCT ID:
NCT06764069
Status:
RECRUITING
Last Update Posted:
2025-01-08
First Post:
2024-12-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Feasibility Study to Evaluate an Intravascular Blood Continuous Glucose Sensor
Sponsor:
Glucotrack
Organization:
Study Overview
Official Title:
Early Feasibility Study to Evaluate an Intravascular Blood Continuous Glucose Sensor in Adults with Diabetes Mellitus
Status:
RECRUITING
Status Verified Date:
2024-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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?
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.
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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
True
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?: