Feasibility Trial of a Sub-conjunctival Insert
NCT07105332 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 8
Last updated 2025-08-05
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.
Conditions
- Diabetes (DM)
Interventions
- DEVICE
-
OMI and Photometer
A glucose sensitive ocular mini insert (OMI) is placed sub-conjunctivaly. When exited by photometer the glucose concentration is measured.
Sponsors & Collaborators
-
EyeSense GmbH
lead INDUSTRY
Principal Investigators
-
Holger Mietz, Prof. Dr. · 63739 Aschaffenburg, Germany
Study Design
- Allocation
- NON_RANDOMIZED
- Purpose
- OTHER
- Masking
- NONE
- Model
- SEQUENTIAL
Eligibility
- Min Age
- 16 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2006-12-31
- Primary Completion
- 2008-06-30
- Completion
- 2008-07-31
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