Investigation of a Sub-Conjunctival Insert

February 24, 2015 updated by: EyeSense GmbH
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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

28

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Heidelberg, Germany, 69115
        • Diabetes Instiut Heidelberg

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Be of legal age
  • Insulin dependent diabetes requiring daily finger pricking to monitor blood glucose
  • Sign written Informed Consent

Exclusion Criteria:

  • Inability to follow the protocol schedule
  • Participating in another clinical study
  • Pregnant or lactating females
  • Any ongoing condition that would prevent from proper handling of the instrument (e.g. blindness, strong impaired vision, impaired motor skills)
  • Any known hypersensitivity to any of the products to be used in the study, including preservatives etc.
  • Malignancies requiring therapy during the study
  • Severe chronic diseases e.g. renal failure, liver cirrhosis etc. which may interfere with the conduct or completion of the study
  • Poorly controlled diabetes mellitus with prior hemoglobin A1C greater than 10%
  • Any ocular disease requiring topical medication besides those permitted by this protocol.
  • Ocular or other condition which increase the risk of ocular surgery, e.g. acute or chronic conjunctivitis or blepharitis, corneal disorders, previous eye surgery or eye surgery within the following 12 weeks, coagulation disorders.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: DIAGNOSTIC
  • Allocation: RANDOMIZED
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: Cohort 1
In the Cohort 1 an uncoated Insert and the photometer version 1 is used. Twelve trial subjects are appointed into 4 subgroups. The difference between these subgroups is the wearing time of the insert.
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.
Other Names:
  • Ocular Mini Insert (OMI)
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.
Other Names:
  • Ocular Mini Insert (OMI)
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.
Other Names:
  • Ocular Mini Insert (OMI)
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.
Other Names:
  • Ocular Mini Insert (OMI)
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.
Other Names:
  • Ocular Mini Insert (OMI)
ACTIVE_COMPARATOR: Cohort 2
Cohort 2 consists of 12 trial subjects who are appointed to 2 subgroups. One group will wear the insert for a minimum of 12 month and the other group for a minimum duration of 18 month. In Cohort 2 an improved insert is used. The photometer will be the same than in cohort 1.
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.
Other Names:
  • Ocular Mini Insert (OMI)
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.
Other Names:
  • Ocular Mini Insert (OMI)
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.
Other Names:
  • Ocular Mini Insert (OMI)
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.
Other Names:
  • Ocular Mini Insert (OMI)
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.
Other Names:
  • Ocular Mini Insert (OMI)
ACTIVE_COMPARATOR: Cohort 3
Cohort 3 only differs in the used photometer from cohort 2.
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.
Other Names:
  • Ocular Mini Insert (OMI)
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.
Other Names:
  • Ocular Mini Insert (OMI)
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.
Other Names:
  • Ocular Mini Insert (OMI)
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.
Other Names:
  • Ocular Mini Insert (OMI)
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.
Other Names:
  • Ocular Mini Insert (OMI)
ACTIVE_COMPARATOR: Cohort 4
Twelve trial subjects are appointed to two subgroups that differ in the minimum wearing duration of the insert (12 month and 18 month). In Cohort 4 a new insert will be tested together with a better photometer.
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.
Other Names:
  • Ocular Mini Insert (OMI)
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.
Other Names:
  • Ocular Mini Insert (OMI)
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.
Other Names:
  • Ocular Mini Insert (OMI)
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.
Other Names:
  • Ocular Mini Insert (OMI)
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.
Other Names:
  • Ocular Mini Insert (OMI)
ACTIVE_COMPARATOR: Cohort 5
The difference between Cohort 5 and Cohort 4 is that the best tested insert and the best evaluated photometer will be used.
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.
Other Names:
  • Ocular Mini Insert (OMI)
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.
Other Names:
  • Ocular Mini Insert (OMI)
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.
Other Names:
  • Ocular Mini Insert (OMI)
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.
Other Names:
  • Ocular Mini Insert (OMI)
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.
Other Names:
  • Ocular Mini Insert (OMI)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
short term and mid term performance of different versions of the insert
Time Frame: at 1 month, at 2 months, at 3 months
at 1 month, at 2 months, at 3 months
recovery from surgery (wound healing)
Time Frame: at 1 month, at 2 months, at 3 months
at 1 month, at 2 months, at 3 months
demonstrate correlation between the fluorescence reading of the insert and capillary blood glucose measurement
Time Frame: at 1 month, at 2 months, at 3 months
at 1 month, at 2 months, at 3 months

Secondary Outcome Measures

Outcome Measure
Time Frame
subjective impressions
Time Frame: 1 year
1 year
lag time between blood glucose and interstitial fluid glucose
Time Frame: at 1 month, at 2 months, at 3 months
at 1 month, at 2 months, at 3 months
signal to noise ration, signal drift and stability of measurement
Time Frame: at 1 month, at 2 months, at 3 months
at 1 month, at 2 months, at 3 months
conjunctival hyperemia
Time Frame: at 1 month, at 2 months, at 3 months
at 1 month, at 2 months, at 3 months
duty of care
Time Frame: at 1 month, at 2 months, at 3 months
at 1 month, at 2 months, at 3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

EyeSense GmbH

Investigators

  • Principal Investigator: Christoph Hasslacher, Prof. Dr. med., Diabetes Institut Heidelberg, Germany
  • Principal Investigator: Gerd Auffarth, Prof. Dr. med., University Hospital Heidelberg, Ophthalmology, Heidelberg, Germany

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2008

Primary Completion (ACTUAL)

March 1, 2012

Study Completion (ACTUAL)

May 1, 2013

Study Registration Dates

First Submitted

September 28, 2009

First Submitted That Met QC Criteria

October 21, 2009

First Posted (ESTIMATE)

October 22, 2009

Study Record Updates

Last Update Posted (ESTIMATE)

February 25, 2015

Last Update Submitted That Met QC Criteria

February 24, 2015

Last Verified

October 1, 2011

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • P-2.1-C-01

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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