Investigation of a Sub-Conjunctival Insert

E

EyeSense

Status

Terminated

Conditions

Diabetes Care

Treatments

Device: GOMIS and Photometer

Study type

Interventional

Funder types

Industry

Identifiers

NCT00999856

P-2.1-C-01

Details and patient eligibility

About

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.

Enrollment

28 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.

Trial design

28 participants in 5 patient groups

Cohort 1

Active Comparator group

Description:

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.

Treatment:

Device: GOMIS and Photometer

Cohort 2

Active Comparator group

Description:

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.

Treatment:

Device: GOMIS and Photometer

Cohort 3

Active Comparator group

Description:

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

Treatment:

Device: GOMIS and Photometer

Cohort 4

Active Comparator group

Description:

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.

Treatment:

Device: GOMIS and Photometer

Cohort 5

Active Comparator group

Description:

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

Treatment:

Device: GOMIS and Photometer

Trial contacts and locations

1

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