Investigation of a Sub-Conjunctival Insert

EyeSense GmbH28 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

Purpose

DEVICE_FEASIBILITY

Enrollment

Conditions

Diabetes Care

Interventions

GOMIS and PhotometerDEVICE

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.

GOMIS and PhotometerDEVICE

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.

GOMIS and PhotometerDEVICE

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.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (1)

Diabetes Instiut Heidelberg

Heidelberg, Germany