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 @ 7:02 PM
Ignite Modification Date:
2025-12-24 @ 7:02 PM
NCT ID:
NCT00985257
Eligibility Criteria:
Inclusion Criteria:
* Type 1 or Type 2 diabetes
* Age 4 to 24 years
* Routinely performs blood glucose testing at home
* If age 18 or older at time informed consent is signed, subject must be able to speak, read, and understand English.
* If younger than age 18, subject's parent/guardian must be able to speak, read, and understand English, and is able to provide appropriate supervision.
* Is willing to complete all study procedures, with or without parent / guardian supervision, if appropriate
Exclusion Criteria:
* Currently pregnant
* Hemophilia or any other bleeding disorder
* Taking prescription anticoagulants (such as Warfarin or heparin) or has clotting problems that may prolong bleeding. Taking Plavix or aspirin daily is not excluded
* Infection with a blood borne pathogen (e.g., HIV, hepatitis)
* Subject or parent/guardian is employee of competitive medical device company
* Cognitive disorder or other condition, which in the opinion of the investigator, would put the person at risk or seriously compromise the integrity of the study
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
4 Years
Maximum Age:
24 Years
Study:
NCT00985257
Study Brief:
Protocol Section:
NCT00985257