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:
2025-12-25 @ 4:59 AM
Ignite Modification Date:
2025-12-25 @ 4:59 AM
NCT ID:
NCT01076218
Eligibility Criteria:
Inclusion Criteria:
* History consistent with Type 1 diabetes for at least 2 years prior to enrollment;
* For at least 6 months prior to enrollment, insulin pump user or multiple daily insulin injections;
* At least 18 years of age;
* Available and capable of following the protocol instructions provided by the healthcare professional;
* Signed and dated Informed Consent form.
Exclusion Criteria:
* Pregnancy;
* Type 2, gestational, or secondary diabetes;
* Known allergy to medical grade adhesives or skin disinfectant;
* Skin abnormalities at the insertion sites that would confound the assessment of the effect of the device on the skin;
* Blood donation within 6 weeks prior to beginning study activities;
* Within past 6 months, severe hypoglycemic episode(s) resulting in hospitalization or loss of consciousness;
* Active myocardial ischemia;
* Previous history of stroke;
* Any other concomitant medical condition that in the opinion of the principal investigator would likely affect the evaluation of device performance and/or safety;
* Current participation in another clinical trial.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01076218
Study Brief:
Protocol Section:
NCT01076218