Investigation of a Sub-Conjunctival Insert

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

28 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-08-31

Study Completion Date

2013-05-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Diabetes Care

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DEVICE_FEASIBILITY

Study Groups

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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.

Group Type ACTIVE_COMPARATOR

GOMIS and Photometer

Intervention Type DEVICE

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.

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.

Group Type ACTIVE_COMPARATOR

GOMIS and Photometer

Intervention Type DEVICE

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.

Cohort 3

Cohort 3 only differs in the used photometer from cohort 2.

Group Type ACTIVE_COMPARATOR

GOMIS and Photometer

Intervention Type DEVICE

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.

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.

Group Type ACTIVE_COMPARATOR

GOMIS and Photometer

Intervention Type DEVICE

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.

Cohort 5

The difference between Cohort 5 and Cohort 4 is that the best tested insert and the best evaluated photometer will be used.

Group Type ACTIVE_COMPARATOR

GOMIS and Photometer

Intervention Type DEVICE

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.

Interventions

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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.

Intervention Type 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.

Intervention Type 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.

Intervention Type 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.

Intervention Type 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.

Intervention Type DEVICE

Other Intervention Names

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Ocular Mini Insert (OMI) Ocular Mini Insert (OMI) Ocular Mini Insert (OMI) Ocular Mini Insert (OMI) Ocular Mini Insert (OMI)

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No