Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
NA
8 participants
INTERVENTIONAL
2006-12-31
2008-07-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SEQUENTIAL
OTHER
NONE
Study Groups
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Cohort - Healthy subjects
2 healthy subjects will test OMI and Photometer for a period of up to 5 months: with sub-conjunctivaly implanted OMI participating on in-clinic sessions to optimize and adjust the measurement system (photometer).
OMI and Photometer
A glucose sensitive ocular mini insert (OMI) is placed sub-conjunctivaly. When exited by photometer the glucose concentration is measured.
Cohort - Diabetic patients
8 diabetic patients will test OMI and Photometer: wearing sub-conjunctivaly implanted OMI for a period of up to 10 months and participating on up to 20 in-clinic sessions with blood glucose challenge to measure the performance of the system.
OMI and Photometer
A glucose sensitive ocular mini insert (OMI) is placed sub-conjunctivaly. When exited by photometer the glucose concentration is measured.
Interventions
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OMI and Photometer
A glucose sensitive ocular mini insert (OMI) is placed sub-conjunctivaly. When exited by photometer the glucose concentration is measured.
Eligibility Criteria
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Inclusion Criteria
2. Signed written Informed Consent.
Exclusion Criteria
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.
16 Years
ALL
Yes
Sponsors
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EyeSense GmbH
INDUSTRY
Responsible Party
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Principal Investigators
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Holger Mietz, Prof. Dr.
Role: PRINCIPAL_INVESTIGATOR
63739 Aschaffenburg, Germany
Other Identifiers
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P-1.1-C-01
Identifier Type: -
Identifier Source: org_study_id
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