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Investigation of a Sub-Conjunctival Insert

NCT00999856 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 28

Last updated 2025-03-06

No results posted yet for this study

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

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.

Sponsors & Collaborators

  • EyeSense GmbH

    lead INDUSTRY

Principal Investigators

  • Christoph Hasslacher, Prof. Dr. med. · Diabetes Institut Heidelberg, Germany

  • Gerd Auffarth, Prof. Dr. med. · University Hospital Heidelberg, Ophthalmology, Heidelberg, Germany

Study Design

Allocation
NA
Purpose
DEVICE_FEASIBILITY
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-08-31
Primary Completion
2012-03-31
Completion
2013-05-31

Countries

  • Germany

Study Locations

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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 NCT00999856 on ClinicalTrials.gov