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 @ 4:17 PM
Ignite Modification Date:
2025-12-24 @ 4:17 PM
NCT ID:
NCT02655666
Eligibility Criteria:
Inclusion Criteria:
* Subject is age \< 18 years at time of screening
* Subject has a clinical diagnosis of type 1 diabetes
* Subject is willing to perform required sensor calibrations
* Subject is willing to wear the Medtronic MiniMed Paradigm® REAL Time System continuously throughout the study
* Subject is a participant in the Qingdao project.
Exclusion Criteria:
* Subject is actively participating in an investigational study (drug or device) wherein he/she has received diabetes treatment from an investigational study drug or investigational study devices in the last 2 weeks
* Subject has known hypersensitivity to insulin or insulin infusion set(including tape)
* Subject has used the insulin pump and/or real time CGM/sensor within 90 days before the screening visit for more than 10 days in the outpatient setting:
* For example, subjects who have used insulin pump and/or real time CGM/sensor in the inpatient setting will still be eligible for enrollment.
* For example, subjects who have used insulin pump and/or real time CGM/sensor for 8 days in the outpatient setting within 90 days before screening visit will still be eligible for enrollment.
* For example, subjects who have worn the insulin pump and/or real time CGM/sensor for 3 months in the outpatient setting a year before the screening visit will still be eligible for enrollment
* Subject has been treated with drugs with a known effect on BG within 8 weeks before enrollment other than diabetes medications such as insulin or oral anti-diabetic agents.
* Subject has any systemic disease or medical condition found on screening that may interfere with the safety of the patient and efficacy of the study treatment, in the opinion of the Investigator, may preclude him/her from participating in the study.
* Subject is being treated for hyperthyroidism at time of screening
* Subject has taken any oral, injectable, or IV steroids within 8 weeks from time of screening visit, or plans to take any oral, injectable, or IV steroids during the course of the study
* Subject is currently abusing alcohol9. Any condition that either the Investigator believes would interfere with study participation or evaluation of results.
Healthy Volunteers:
False
Sex:
ALL
Maximum Age:
18 Years
Study:
NCT02655666
Study Brief:
Protocol Section:
NCT02655666