Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 11:28 PM
Ignite Modification Date:
2025-12-24 @ 11:28 PM
NCT ID:
NCT00999856
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.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00999856
Study Brief:
Protocol Section:
NCT00999856