Investigation of a Sub-Conjunctival Insert

NCT00999856 | Terminated

• 1 other identifier: P-2.1-C-01
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

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.

Conditions

Diabetes Care

Keywords

medical device,; sub-conjunctival insert; photometer; fluorescence; subconjunctival interstitial fluid glucose; non-invasive measurement

Outcome Measures

Primary Outcomes (3)

• short term and mid term performance of different versions of the insert

  at 1 month, at 2 months, at 3 months

• recovery from surgery (wound healing)

  at 1 month, at 2 months, at 3 months

• demonstrate correlation between the fluorescence reading of the insert and capillary blood glucose measurement

  at 1 month, at 2 months, at 3 months

Secondary Outcomes (5)

• subjective impressions

  1 year

• lag time between blood glucose and interstitial fluid glucose

  at 1 month, at 2 months, at 3 months

• signal to noise ration, signal drift and stability of measurement

  at 1 month, at 2 months, at 3 months

• conjunctival hyperemia

  at 1 month, at 2 months, at 3 months

• duty of care

  at 1 month, at 2 months, at 3 months

Study Arms (5)

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.

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.

Device: GOMIS and Photometer

Cohort 3

ACTIVE COMPARATOR

Cohort 3 only differs in the used photometer from cohort 2.

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.

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.

Device: GOMIS and Photometer

Interventions

GOMIS and Photometer DEVICE

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.

Also known as: Ocular Mini Insert (OMI)

Cohort 1

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Be of legal age
• Insulin dependent diabetes requiring daily finger pricking to monitor blood glucose
• Sign written Informed Consent

You may not qualify if:

• 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.

Sponsors & Collaborators

• EyeSense GmbH: lead

Study Sites (1)

Diabetes Instiut Heidelberg

Heidelberg, 69115, Germany

Location

Related Publications (1)

• 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.

  PMID: 22341132 DERIVED

Related Links

• Publication of Study Data
• EyeSense GmbH

Study Officials

• Christoph Hasslacher, Prof. Dr. med.

  Diabetes Institut Heidelberg, Germany

  PRINCIPAL INVESTIGATOR

• Gerd Auffarth, Prof. Dr. med.

  University Hospital Heidelberg, Ophthalmology, Heidelberg, Germany

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Purpose: DEVICE FEASIBILITY
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 28, 2009
• First Posted: October 22, 2009
• Study Start: August 1, 2008
• Primary Completion: March 1, 2012
• Study Completion: May 1, 2013
• Last Updated: March 6, 2025

Record last verified: 2025-03

Locations

DE (1)