NCT00999856

Investigation of a Sub-Conjunctival Insert

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 28 (actual)
• Sponsor: EyeSense GmbH · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Diabetes Care

Interventions

Type	Name	Description
DEVICE	GOMIS and Photometer	Insert is placed under the conjunctiva. During measurement sessions photometer will be placed in front of the eye in which the insert is located to perform the fluorescence measuring.
DEVICE	GOMIS and Photometer	An improved insert is placed under the conjunctiva. During measurement sessions photometer will be placed in front of the eye in which the insert is located to perform the fluorescence measuring.
DEVICE	GOMIS and Photometer	Insert is placed under the conjunctiva. During measurement sessions photometer version 2 will be placed in front of the eye in which the insert is located to perform the fluorescence measuring.
DEVICE	GOMIS and Photometer	After comparing Photometer Version 1 and Version 2 the better one of them will be used for measurements in Cohort 4. A new insert will be implanted under the conjunctiva.
DEVICE	GOMIS and Photometer	The insert version with the best results will be implanted. The photometer that was used in Cohort 4 will be taken again for fluorescence measurements.

Timeline

• Start date: 2008-08-01
• Primary completion: 2012-03-01
• Completion: 2013-05-01
• First posted: 2009-10-22
• Last updated: 2025-03-06

Locations

1 site across 1 country: Germany