Diabetes CareNCT00999856
Investigation of a Sub-Conjunctival Insert
A study testing GOMIS and Photometer in people with Diabetes Care, run by EyeSense GmbH at 1 site in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetes Care
- What is being tested?
- GOMIS and Photometer
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 1 siteGermany
- Study dates
- Aug 2008to May 2013
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Be of legal age
- Insulin dependent diabetes requiring daily finger pricking to monitor blood glucose
- Sign written Informed Consent
Who cannot join
- 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
Show all 10Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Diabetes Care
- Being tested
- GOMIS and Photometer
- Keywords
- medical device,, sub-conjunctival insert, photometer, fluorescence, subconjunctival interstitial fluid glucose, non-invasive measurement
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GOMIS and PhotometerDevice
Also called Ocular Mini Insert (OMI)
Insert is placed under the conjunctiva. During measurement sessions photometer will be placed in front of the eye in which the insert is located to perform the fluorescence measuring.
GOMIS and PhotometerDevice
Also called Ocular Mini Insert (OMI)
An improved insert is placed under the conjunctiva. During measurement sessions photometer will be placed in front of the eye in which the insert is located to perform the fluorescence measuring.
GOMIS and PhotometerDevice
Also called Ocular Mini Insert (OMI)
Insert is placed under the conjunctiva. During measurement sessions photometer version 2 will be placed in front of the eye in which the insert is located to perform the fluorescence measuring.
GOMIS and PhotometerDevice
Also called Ocular Mini Insert (OMI)
After comparing Photometer Version 1 and Version 2 the better one of them will be used for measurements in Cohort 4. A new insert will be implanted under the conjunctiva.
GOMIS and PhotometerDevice
Also called Ocular Mini Insert (OMI)
The insert version with the best results will be implanted. The photometer that was used in Cohort 4 will be taken again for fluorescence measurements.
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1 | Active comparator | 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. Receives: Device: GOMIS and Photometer |
| Cohort 2 | Active comparator | 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. Receives: Device: GOMIS and Photometer |
| Cohort 3 | Active comparator | Cohort 3 only differs in the used photometer from cohort 2. Receives: Device: GOMIS and Photometer |
| Cohort 4 | Active comparator | 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. Receives: Device: GOMIS and Photometer |
| Cohort 5 | Active comparator | The difference between Cohort 5 and Cohort 4 is that the best tested insert and the best evaluated photometer will be used. Receives: Device: GOMIS and Photometer |
What is being measured
The primary outcome is the main question the study is designed to answer.
short term and mid term performance of different versions of the insert
Measured: at 1 month, at 2 months, at 3 months
recovery from surgery (wound healing)
Measured: at 1 month, at 2 months, at 3 months
demonstrate correlation between the fluorescence reading of the insert and capillary blood glucose measurement
Measured: at 1 month, at 2 months, at 3 months
Secondary outcomes (5)
subjective impressions
Measured: 1 year
lag time between blood glucose and interstitial fluid glucose
Measured: at 1 month, at 2 months, at 3 months
signal to noise ration, signal drift and stability of measurement
Measured: at 1 month, at 2 months, at 3 months
conjunctival hyperemia
Measured: at 1 month, at 2 months, at 3 months
duty of care
Measured: at 1 month, at 2 months, at 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Oct 2009 (estimated)
- Study startAug 2008
- Primary completionMar 2012
- Study completionMay 2013
Why it stopped: Two cohorts successfully completed; further cohorts not needed; no safety issue!
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Diabetes CareStudies 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
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- EyeSense GmbH
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Christoph Hasslacher, Prof. Dr. med., Principal investigator, Diabetes Institut Heidelberg, GermanyGerd Auffarth, Prof. Dr. med., Principal investigator, University Hospital Heidelberg, Ophthalmology, Heidelberg, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00999856
- Sponsor's protocol ID
- P-2.1-C-01
- Status last verified
- Mar 2025
- First submitted
- 28 Sep 2009
- Last updated
- 6 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
Publications
Hasslacher C, Auffarth G, Platten I, Rabsilber T, Smith B, Kulozik F, Knuth M, Nikolaus K, Muller A. Safety and accuracy of a new long-term subconjunctival glucose sensor. J Diabetes. 2012 Sep;4(3):291-6. doi: 10.1111/j.1753-0407.2012.00192.x.
PubMed 22341132
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 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
- NCT00999856
- Acronym / sponsor ID
- P-2.1-C-01
- Conditions
- Diabetes Care
- Keywords
- medical device,, sub-conjunctival insert, photometer, fluorescence, subconjunctival interstitial fluid glucose, non-invasive measurement
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Two cohorts successfully completed; further cohorts not needed; no safety issue!
- Enrolment
- 28 participants (actual)
- Lead sponsor
- EyeSense GmbHIndustry (pharma, biotech, devices)
- Study start
- Aug 2008
- Primary completion
- Mar 2012 (actual)
- Study completion
- May 2013 (actual)
- First posted
- 22 Oct 2009 (estimated)
- 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 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.
Study design
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 | Active comparator | Device: GOMIS and PhotometerIn 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 | Active comparator | Device: GOMIS and PhotometerCohort 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 | Active comparator | Device: GOMIS and PhotometerCohort 3 only differs in the used photometer from cohort 2. |
| Cohort 4 | Active comparator | Device: GOMIS and PhotometerTwelve 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 | Active comparator | Device: GOMIS and PhotometerThe difference between Cohort 5 and Cohort 4 is that the best tested insert and the best evaluated photometer will be used. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Be of legal age
- Insulin dependent diabetes requiring daily finger pricking to monitor blood glucose
- Sign written Informed Consent
Key exclusion criteria (10 listed)
- 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.
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 |
|---|---|---|
| GOMIS and PhotometerAlso: Ocular Mini Insert (OMI)Insert is placed under the conjunctiva. During measurement sessions photometer will be placed in front of the eye in which the insert is located to perform the fluorescence measuring. | Device | Cohort 1 |
| GOMIS and PhotometerAlso: Ocular Mini Insert (OMI)An improved insert is placed under the conjunctiva. During measurement sessions photometer will be placed in front of the eye in which the insert is located to perform the fluorescence measuring. | Device | Cohort 2 |
| GOMIS and PhotometerAlso: Ocular Mini Insert (OMI)Insert is placed under the conjunctiva. During measurement sessions photometer version 2 will be placed in front of the eye in which the insert is located to perform the fluorescence measuring. | Device | Cohort 3 |
| GOMIS and PhotometerAlso: Ocular Mini Insert (OMI)After comparing Photometer Version 1 and Version 2 the better one of them will be used for measurements in Cohort 4. A new insert will be implanted under the conjunctiva. | Device | Cohort 4 |
| GOMIS and PhotometerAlso: Ocular Mini Insert (OMI)The insert version with the best results will be implanted. The photometer that was used in Cohort 4 will be taken again for fluorescence measurements. | Device | Cohort 5 |
Primary outcome
short term and mid term performance of different versions of the insert
Time frame: at 1 month, at 2 months, at 3 months
recovery from surgery (wound healing)
Time frame: at 1 month, at 2 months, at 3 months
demonstrate correlation between the fluorescence reading of the insert and capillary blood glucose measurement
Time frame: at 1 month, at 2 months, at 3 months
5 secondary outcomes
subjective impressions
Time frame: 1 year
lag time between blood glucose and interstitial fluid glucose
Time frame: at 1 month, at 2 months, at 3 months
signal to noise ration, signal drift and stability of measurement
Time frame: at 1 month, at 2 months, at 3 months
conjunctival hyperemia
Time frame: at 1 month, at 2 months, at 3 months
duty of care
Time frame: at 1 month, at 2 months, at 3 months
Results and safety
The study was stopped early (reason given: Two cohorts successfully completed; further cohorts not needed; no safety issue!). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Mar 2025.
- Derived from this study: PubMed 22341132Hasslacher C, Auffarth G, Platten I, Rabsilber T, Smith B, Kulozik F, Knuth M, Nikolaus K, Muller A. Safety and accuracy of a new long-term subconjunctival glucose sensor. J Diabetes. 2012 Sep;4(3):291-6. doi: 10.1111/j.1753-0407.2012.00192.x.
- Publication of Study DataLink provided by the sponsor.
- EyeSense GmbHLink provided by the sponsor.
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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.
Christoph Hasslacher, Prof. Dr. med. principal investigator
Diabetes Institut Heidelberg, Germany
Gerd Auffarth, Prof. Dr. med. principal investigator
University Hospital Heidelberg, Ophthalmology, Heidelberg, Germany
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing GOMIS and Photometer in people with Diabetes Care, run by EyeSense GmbH at 1 site in Germany.
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 3 inclusion and 10 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 6 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
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: Two cohorts successfully completed; further cohorts not needed; no safety issue!). 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?
short term and mid term performance of different versions of the insert (time frame: at 1 month, at 2 months, at 3 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00999856, which also lists 1 linked publication.
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 6 Mar 2025.