Investigation of a Sub-Conjunctival Insert
March 4, 2025 updated by: EyeSense GmbH
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 Overview
Status
Terminated
Conditions
Study Type
Interventional
Enrollment (Actual)
28
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Heidelberg, Germany, 69115
- Diabetes Instiut Heidelberg
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- Be of legal age
- Insulin dependent diabetes requiring daily finger pricking to monitor blood glucose
- Sign written Informed Consent
Exclusion Criteria:
- 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
- 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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Device Feasibility
- Allocation: N/A
- Interventional Model: Single Group Assignment
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Cohort 1
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.
|
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.
Other Names:
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.
Other Names:
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.
Other Names:
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.
Other Names:
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.
Other Names:
|
|
Active Comparator: Cohort 2
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.
|
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.
Other Names:
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.
Other Names:
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.
Other Names:
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.
Other Names:
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.
Other Names:
|
|
Active Comparator: Cohort 3
Cohort 3 only differs in the used photometer from cohort 2.
|
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.
Other Names:
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.
Other Names:
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.
Other Names:
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.
Other Names:
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.
Other Names:
|
|
Active Comparator: Cohort 4
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.
|
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.
Other Names:
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.
Other Names:
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.
Other Names:
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.
Other Names:
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.
Other Names:
|
|
Active Comparator: Cohort 5
The difference between Cohort 5 and Cohort 4 is that the best tested insert and the best evaluated photometer will be used.
|
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.
Other Names:
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.
Other Names:
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.
Other Names:
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.
Other Names:
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.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
short term and mid term performance of different versions of the insert
Time Frame: at 1 month, at 2 months, at 3 months
|
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
|
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
|
at 1 month, at 2 months, at 3 months
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
subjective impressions
Time Frame: 1 year
|
1 year
|
|
lag time between blood glucose and interstitial fluid glucose
Time Frame: at 1 month, at 2 months, at 3 months
|
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
|
at 1 month, at 2 months, at 3 months
|
|
conjunctival hyperemia
Time Frame: at 1 month, at 2 months, at 3 months
|
at 1 month, at 2 months, at 3 months
|
|
duty of care
Time Frame: at 1 month, at 2 months, at 3 months
|
at 1 month, at 2 months, at 3 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Christoph Hasslacher, Prof. Dr. med., Diabetes Institut Heidelberg, Germany
- Principal Investigator: Gerd Auffarth, Prof. Dr. med., University Hospital Heidelberg, Ophthalmology, Heidelberg, Germany
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
August 1, 2008
Primary Completion (Actual)
March 1, 2012
Study Completion (Actual)
May 1, 2013
Study Registration Dates
First Submitted
September 28, 2009
First Submitted That Met QC Criteria
October 21, 2009
First Posted (Estimated)
October 22, 2009
Study Record Updates
Last Update Posted (Actual)
March 25, 2025
Last Update Submitted That Met QC Criteria
March 4, 2025
Last Verified
March 1, 2025
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- P-2.1-C-01
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.