Investigation of a Sub-Conjunctival Insert

The recruitment status of this study is unknown because the information has not been verified recently.
Verified October 2011 by EyeSense GmbH.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by (Responsible Party):
EyeSense GmbH
ClinicalTrials.gov Identifier:
NCT00999856
First received: September 28, 2009
Last updated: October 28, 2011
Last verified: October 2011
  Purpose

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.


Condition Intervention Phase
Diabetes Care
Device: GOMIS and Photometer
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Investigation of a Sub-Conjunctival Insert

Resource links provided by NLM:


Further study details as provided by EyeSense GmbH:

Primary Outcome Measures:
  • short term and mid term performance of different versions of the insert [ Time Frame: at 1 month, at 2 months, at 3 months ] [ Designated as safety issue: Yes ]
  • recovery from surgery (wound healing) [ Time Frame: at 1 month, at 2 months, at 3 months ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • subjective impressions [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
  • lag time between blood glucose and interstitial fluid glucose [ Time Frame: at 1 month, at 2 months, at 3 months ] [ Designated as safety issue: No ]
  • signal to noise ration, signal drift and stability of measurement [ Time Frame: at 1 month, at 2 months, at 3 months ] [ Designated as safety issue: No ]
  • conjunctival hyperemia [ Time Frame: at 1 month, at 2 months, at 3 months ] [ Designated as safety issue: Yes ]
  • duty of care [ Time Frame: at 1 month, at 2 months, at 3 months ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 65
Study Start Date: August 2008
Estimated Study Completion Date: June 2013
Estimated Primary Completion Date: March 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
Device: GOMIS and 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 Name: Ocular Mini Insert (OMI)
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.
Device: GOMIS and Photometer
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 Name: Ocular Mini Insert (OMI)
Active Comparator: Cohort 3
Cohort 3 only differs in the used photometer from cohort 2.
Device: GOMIS and Photometer
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 Name: Ocular Mini Insert (OMI)
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.
Device: GOMIS and Photometer
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 Name: Ocular Mini Insert (OMI)
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.
Device: GOMIS and Photometer
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 Name: Ocular Mini Insert (OMI)

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00999856

Locations
Germany
Diabetes Instiut Heidelberg
Heidelberg, Germany, 69115
Sponsors and Collaborators
EyeSense GmbH
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
  More Information

Additional Information:
No publications provided by EyeSense GmbH

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: EyeSense GmbH
ClinicalTrials.gov Identifier: NCT00999856     History of Changes
Other Study ID Numbers: P-2.1-C-01
Study First Received: September 28, 2009
Last Updated: October 28, 2011
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by EyeSense GmbH:
medical device,
sub-conjunctival insert
photometer
fluorescence
subconjunctival interstitial fluid glucose
non-invasive measurement

ClinicalTrials.gov processed this record on August 20, 2014