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 @ 2:58 PM
Ignite Modification Date:
2025-12-24 @ 2:58 PM
NCT ID:
NCT01775059
Eligibility Criteria:
Inclusion Criteria:
* Subject is 18 years of age or older at time of screening
* Subject has a clinical diagnosis of insulin requiring diabetes, as determined by investigator.
* Subject is currently using a Medtronic Paradigm Sensor Augmented insulin pump and has been so for a minimum of 3 months at time of enrollment.
* Subject has Continuous Glucose Monitoring experience (min 30% of CGM use within the month prior to enrollment).
* Subject has an average of 3 SMBG per day (verified via CareLink) during the month prior to enrollment.
* Subject is willing to wear the study devices for the duration of the study
* Subject is willing to perform frequent (min 7 per day) SMBGs during study device wear
* Subject is willing to keep a short diary during the device wear.
Exclusion Criteria:
* Female subject is pregnant, per urine pregnancy test performed at time of enrollment in women of child bearing age.
* Female subject plans to become pregnant during the course of the study.
* Subject is unable to tolerate tape adhesive in the area of the placement of the study device.
* Subject has any unresolved adverse skin condition in the area of the placement of the study device (e.g. psoriasis, rash, Staphylococcus infection).
* The subject is not deemed to be an appropriate candidate for the study by the investigator for any reason.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01775059
Study Brief:
Protocol Section:
NCT01775059