Investigation of a Sub-Conjunctival Insert

• short term and mid term performance of different versions of the insert [ Time Frame: at 1 month, at 2 months, at 3 months ] [ Designated as safety issue: Yes ]
• recovery from surgery (wound healing) [ Time Frame: at 1 month, at 2 months, at 3 months ] [ Designated as safety issue: Yes ]
• 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 ] [ Designated as safety issue: No ]

• subjective impressions [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
• lag time between blood glucose and interstitial fluid glucose [ Time Frame: at 1 month, at 2 months, at 3 months ] [ Designated as safety issue: No ]
• signal to noise ration, signal drift and stability of measurement [ Time Frame: at 1 month, at 2 months, at 3 months ] [ Designated as safety issue: No ]
• conjunctival hyperemia [ Time Frame: at 1 month, at 2 months, at 3 months ] [ Designated as safety issue: Yes ]
• duty of care [ Time Frame: at 1 month, at 2 months, at 3 months ] [ Designated as safety issue: Yes ]

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.

• 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 Name: 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 Name: 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 Name: 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 Name: 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 Name: Ocular Mini Insert (OMI)

• 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.
  Intervention: Device: GOMIS and Photometer
• 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.
  Intervention: Device: GOMIS and Photometer
• Active Comparator: Cohort 3
  Cohort 3 only differs in the used photometer from cohort 2.
  Intervention: Device: GOMIS and Photometer
• 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.
  Intervention: Device: GOMIS and Photometer
• 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.
  Intervention: Device: GOMIS and Photometer

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.