Diabetes (DM)OMINCT07105332
Feasibility Trial of a Sub-conjunctival Insert
A study testing OMI and Photometer in people with Diabetes (DM), run by EyeSense GmbH.
Trial 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. Read more about this study
- Who is it for?
- Ages 16 years and olderHealthy volunteers can take part
- Conditions the study is for
- Diabetes (DM)
- What is being tested?
- OMI and Photometer
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- No sites listed yet
- Study dates
- Dec 2006to Jul 2008
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Be of legal age or alternatively above 16 with written persmission of legal guardian.
- Signed written Informed Consent.
Who cannot join
- Pregnant or lactating females.
- Poorly controlled diabetes mellitus with prior hemoglobin A1C greater than 10% or fasting glucose over 150 mg/dl.
- Any known allergies, especially iodine.
- Glaucoma patient.
- Any acute disease.
- Any present condition that would prevent from fasting or glucose challenge.
- Any present condition that would prevent from insertion.
About this study
Official title: Investigation of a Sub-Conjunctival Insert
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)
- Being tested
- OMI and Photometer
- Keywords
- sub-conjunctival implant, flash glucose monitoring, EyeSense, eye implant, glucose measurement in the eye
- Medical subject headings
- Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OMI and PhotometerDevice
A glucose sensitive ocular mini insert (OMI) is placed sub-conjunctivaly. When exited by photometer the glucose concentration is measured.
| Study group | Role | What they receive |
|---|---|---|
| Cohort - Healthy subjects | Experimental | 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). Receives: Device: OMI and Photometer |
| Cohort - Diabetic patients | Experimental | 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. Receives: Device: OMI and Photometer |
What is being measured
The primary outcome is the main question the study is designed to answer.
Correlation between OMI signal and blood glucose
Correlation between OMI fluorescence readings of subconjunctival interstitial fluid glucose concentration and capillary blood glucose level
Measured: 1-2 times weekly for 10 weeks after insertion
Adverse Events Reporting
wound healing and conjunctival hyperaemia
Measured: at each visit, up to 10 months
Secondary outcomes (5)
Sensitivity and signal to noise ratio of the photometer
Measured: 1-2 times weekly for 10 weeks after insertion
Long term stability of insert
signal drift and stability of measurement
Measured: 1-2 times weekly for 10 weeks after insertion
Targeting of measurement beam
Measured: 1-2 times weekly for 10 weeks after insertion
Subjective impressions
subjecs has to answer a questionnaire
Measured: 10 months
Lag time
evaluation between device readings and blood glucose concentration
Measured: 1-2 times weekly for 10 weeks after insertion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2025
- Study startDec 2006
- Primary completionJun 2008
- Study completionJul 2008
Why it stopped: terminated after the concept feasibility was succesfully proved, no safety issues
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes (DM)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- EyeSense GmbH
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Holger Mietz, Prof. Dr., Principal investigator, 63739 Aschaffenburg, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07105332
- Sponsor's protocol ID
- P-1.1-C-01
- Acronym
- OMI
- Status last verified
- Mar 2025
- First submitted
- 5 Sep 2022
- Last updated
- 5 Aug 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of a Sub-Conjunctival Insert
- ClinicalTrials.gov ID
- NCT07105332
- Acronym / sponsor ID
- OMI / P-1.1-C-01
- Conditions
- Diabetes (DM)
- Keywords
- sub-conjunctival implant, flash glucose monitoring, EyeSense, eye implant, glucose measurement in the eye
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: terminated after the concept feasibility was succesfully proved, no safety issues
- Enrolment
- 8 participants (actual)
- Lead sponsor
- EyeSense GmbHIndustry (pharma, biotech, devices)
- Study start
- Dec 2006 (actual)
- Primary completion
- Jun 2008 (actual)
- Study completion
- Jul 2008 (actual)
- First posted
- 5 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cohort - Healthy subjects | Experimental | Device: OMI and Photometer2 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). |
| Cohort - Diabetic patients | Experimental | Device: OMI and Photometer8 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. |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Be of legal age or alternatively above 16 with written persmission of legal guardian.
- Signed written Informed Consent.
Key exclusion criteria (7 listed)
- Pregnant or lactating females.
- Poorly controlled diabetes mellitus with prior hemoglobin A1C greater than 10% or fasting glucose over 150 mg/dl.
- Any known allergies, especially iodine.
- Glaucoma patient.
- Any acute disease.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| OMI and PhotometerA glucose sensitive ocular mini insert (OMI) is placed sub-conjunctivaly. When exited by photometer the glucose concentration is measured. | Device | Cohort - Diabetic patients, Cohort - Healthy subjects |
Primary outcome
Correlation between OMI signal and blood glucose
Time frame: 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
Time frame: at each visit, up to 10 months
wound healing and conjunctival hyperaemia
5 secondary outcomes
Sensitivity and signal to noise ratio of the photometer
Time frame: 1-2 times weekly for 10 weeks after insertion
Long term stability of insert
Time frame: 1-2 times weekly for 10 weeks after insertion
Targeting of measurement beam
Time frame: 1-2 times weekly for 10 weeks after insertion
Subjective impressions
Time frame: 10 months
Lag time
Time frame: 1-2 times weekly for 10 weeks after insertion
Results and safety
The study was stopped early (reason given: terminated after the concept feasibility was succesfully proved, no safety issues). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Aug 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Holger Mietz, Prof. Dr. principal investigator
63739 Aschaffenburg, Germany
Questions about this trial
What is this clinical trial studying?
A study testing OMI and Photometer in people with Diabetes (DM), run by EyeSense GmbH.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 5 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: terminated after the concept feasibility was succesfully proved, no safety issues). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Correlation between OMI signal and blood glucose (time frame: 1-2 times weekly for 10 weeks after insertion). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Aug 2025.