Clinical trial NCT00999856: Investigation of a Sub-Conjunctival Insert
Official title: Investigation of a Sub-Conjunctival Insert
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Diabetes Care
Keywords: medical device,
sub-conjunctival insert
photometer
fluorescence
subconjunctival interstitial fluid glucose
non-invasive measurement
Lead sponsor: EyeSense GmbH
Sponsor class: INDUSTRY
First posted: 2009-10-22
Enrollment: 28
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DEVICE_FEASIBILITY

Brief 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. The goal is to prove that the sensor signal correlates with the blood glucose of the patients determined by standard laboratory blood glucose measurement.


Eligibility criteria: 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.

Primary outcomes:
measure: short term and mid term performance of different versions of the insert
timeFrame: at 1 month, at 2 months, at 3 months
measure: recovery from surgery (wound healing)
timeFrame: at 1 month, at 2 months, at 3 months
measure: demonstrate correlation between the fluorescence reading of the insert and capillary blood glucose measurement
timeFrame: at 1 month, at 2 months, at 3 months
Secondary outcomes:
measure: subjective impressions
timeFrame: 1 year
measure: lag time between blood glucose and interstitial fluid glucose
timeFrame: at 1 month, at 2 months, at 3 months
measure: signal to noise ration, signal drift and stability of measurement
timeFrame: at 1 month, at 2 months, at 3 months
measure: conjunctival hyperemia
timeFrame: at 1 month, at 2 months, at 3 months
measure: duty of care
timeFrame: at 1 month, at 2 months, at 3 months
Other outcomes:
Locations:
city: Heidelberg
country: Germany
facility: Diabetes Instiut Heidelberg
Study officials:
affiliation: Diabetes Institut Heidelberg, Germany
name: Christoph Hasslacher, Prof. Dr. med.
role: PRINCIPAL_INVESTIGATOR
affiliation: University Hospital Heidelberg, Ophthalmology, Heidelberg, Germany
name: Gerd Auffarth, Prof. Dr. med.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.