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 @ 5:35 PM
Ignite Modification Date:
2025-12-24 @ 5:35 PM
NCT ID:
NCT01773668
Eligibility Criteria:
Inclusion Criteria:
* Subject is 21-70 years of age at time of screening (age criteria chosen in order to comply with other studies in the same field of research).
* Subject has a clinical diagnose of type 1 or type 2 diabetes, as determined by investigator.
* Subject has one or more established insulin carbohydrate ratio.
* Subject has one or more established insulin correction ratio.
* Subject is a high bolus user (\>10 units/meal) for at least one meal a day.
* Subject is currently using a Medtronic insulin pump and has been so for a minimum of 3 months at time of enrollment.
* Subject has been using insulin for more than one year.
* Subject is willing to wear two pumps, one sensor, one infusion set and one Integrated sensor and infusion set at one time (first night).
* Subject is willing to perform frequent SMBGs during Visits 3 and 4.
* Subject is in good general health without other acute or chronic illnesses.
Exclusion Criteria:
* Vulnerable population will not be included in the study
* Subject is pregnant as per urine test or lactating (if female), as self-declared by patient.
* Subject plans to become pregnant during the course of the study.
* Subject is unable to tolerate tape adhesive in the area of sensor placement.
* Subject has any unresolved adverse skin condition in the area of sensor or device placement (e.g. psoriasis, rash, Staphylococcus infection).
* The subject has complications such as advanced autonomic neuropathy, legal blindness, or symptomatic cardiovascular disease as evidenced by a cardiovascular episode within the last six months.
* The subject has any major concomitant disease or any physical or psychological disorder within the last five years, which might be considered life threatening or which might confound the collection or interpretation of the study data.
* The subject has experienced two or more severe hypoglycemic events - seizures/coma requiring assistance in the past 6 months.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
21 Years
Maximum Age:
70 Years
Study:
NCT01773668
Study Brief:
Protocol Section:
NCT01773668