Investigation of a Sub-Conjunctival Insert

Study Overview
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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.

Official Title
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Investigation of a Sub-Conjunctival Insert

Conditions
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Diabetes Care

Intervention / Treatment
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* Device: GOMIS and Photometer
* Device: GOMIS and Photometer
* Device: GOMIS and Photometer
* Device: GOMIS and Photometer
* Device: GOMIS and Photometer


Participation Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Cohort 1<br>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<br>* 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.<br>* Other names: Ocular Mini Insert (OMI);|
| Active Comparator: Cohort 2<br>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<br>* 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.<br>* Other names: Ocular Mini Insert (OMI);|
| Active Comparator: Cohort 3<br>Cohort 3 only differs in the used photometer from cohort 2. | Device: GOMIS and Photometer<br>* 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.<br>* Other names: Ocular Mini Insert (OMI);|
| Active Comparator: Cohort 4<br>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<br>* 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.<br>* Other names: Ocular Mini Insert (OMI);|
| Active Comparator: Cohort 5<br>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<br>* 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.<br>* Other names: Ocular Mini Insert (OMI);|

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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medical device,, sub-conjunctival insert, photometer, fluorescence, subconjunctival interstitial fluid glucose, non-invasive measurement