Ignite Creation Date:
2025-12-24 @ 11:28 PM
Ignite Modification Date:
2026-01-04 @ 12:17 AM
Study NCT ID:
NCT00999856
Status:
TERMINATED
Last Update Posted:
2025-03-06
First Post:
2009-09-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Investigation of a Sub-Conjunctival Insert
Sponsor:
EyeSense GmbH
Organization:
Study Overview
Official Title:
Investigation of a Sub-Conjunctival Insert
Status:
TERMINATED
Status Verified Date:
2025-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Two cohorts successfully completed; further cohorts not needed; no safety issue!
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The study is intended to evaluate a non-invasive method of glucose measurement in diabetics. The medical device that is evaluated consists on a sensor-insert which is placed under the conjunctiva of the eye of diabetic patients and a photometer. The goal is to prove that the sensor signal correlates with the blood glucose of the patients determined by standard laboratory blood glucose measurement.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: