Diabetes (DM)
Conditions
Keywords
sub-conjunctival implant, flash glucose monitoring, EyeSense, eye implant, glucose measurement in the eye
Brief summary
The purpose of this single-centre, open label prospective study is to investigate a novel ocular mini insert (OMI) for detection of blood glucose levels in human subjects. First, the optimal technical parameters for measurement are determined on healthy subjects. Secondly, performance measurements follow investigating relationship between OMI signal and blood glucose in diabetes patients during short sessions with oral glucose tolerace test.
Interventions
DEVICEOMI and Photometer
A glucose sensitive ocular mini insert (OMI) is placed sub-conjunctivaly. When exited by photometer the glucose concentration is measured.
Sponsors
EyeSense GmbH
Study design
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
16 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
1. Be of legal age or alternatively above 16 with written persmission of legal guardian. 2. Signed written Informed Consent.
Exclusion criteria
1. Pregnant or lactating females. 2. Poorly controlled diabetes mellitus with prior hemoglobin A1C greater than 10% or fasting glucose over 150 mg/dl. 3. Any known allergies, especially iodine. 4. Glaucoma patient. 5. Any acute disease. 6. Any present condition that would prevent from fasting or glucose challenge. 7. Any present condition that would prevent from insertion.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Correlation between OMI signal and blood glucose | 1-2 times weekly for 10 weeks after insertion | Correlation between OMI fluorescence readings of subconjunctival interstitial fluid glucose concentration and capillary blood glucose level |
| Adverse Events Reporting | at each visit, up to 10 months | wound healing and conjunctival hyperaemia |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Targeting of measurement beam | 1-2 times weekly for 10 weeks after insertion | — |
| Sensitivity and signal to noise ratio of the photometer | 1-2 times weekly for 10 weeks after insertion | — |
| Lag time | 1-2 times weekly for 10 weeks after insertion | evaluation between device readings and blood glucose concentration |
| Subjective impressions | 10 months | subjecs has to answer a questionnaire |
| Long term stability of insert | 1-2 times weekly for 10 weeks after insertion | signal drift and stability of measurement |
Outcome results
None listed