Diabetes Care
Conditions
Keywords
medical device,, sub-conjunctival insert, photometer, fluorescence, subconjunctival interstitial fluid glucose, non-invasive measurement
Brief summary
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.
Interventions
DEVICEGOMIS 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.
Sponsors
EyeSense GmbH
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DEVICE_FEASIBILITY
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | 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
| Measure | Time frame |
|---|---|
| conjunctival hyperemia | at 1 month, at 2 months, at 3 months |
| subjective impressions | 1 year |
| duty of care | at 1 month, at 2 months, at 3 months |
| 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 |
Countries
Germany
Outcome results
None listed