Investigation of a Sub-Conjunctival Insert
Not Applicable
Terminated
- Conditions
- Diabetes Care
- Interventions
- Device: GOMIS and Photometer
- Registration Number
- NCT00999856
- Lead Sponsor
- EyeSense GmbH
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 28
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Cohort 1 GOMIS and Photometer 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. Cohort 2 GOMIS and Photometer 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. Cohort 3 GOMIS and Photometer Cohort 3 only differs in the used photometer from cohort 2. Cohort 4 GOMIS and Photometer 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. Cohort 5 GOMIS and Photometer The difference between Cohort 5 and Cohort 4 is that the best tested insert and the best evaluated photometer will be used.
- Primary Outcome Measures
Name Time Method recovery from surgery (wound healing) at 1 month, at 2 months, at 3 months short term and mid term performance of different versions of the insert 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
Name Time Method subjective impressions 1 year conjunctival hyperemia at 1 month, at 2 months, at 3 months 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
Trial Locations
- Locations (1)
Diabetes Instiut Heidelberg
🇩🇪Heidelberg, Germany