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 @ 3:03 AM
Ignite Modification Date:
2025-12-25 @ 3:03 AM
NCT ID:
NCT04936633
Eligibility Criteria:
Inclusion Criteria:
* Men or women aged 19 to 75 years old
* Patients with type 1 diabetes
* Patients on multiple daily insulin-injection or continuous subcutaneous insulin infusion therapy for more than 1 year
* Patients with HbA1c ≥ 7.0% at screening
* Patients willing to use a FSGM system
* Patients with informed consent
Exclusion Criteria:
* Gestational diabetes patients
* Patients within 1 year of diabetic diagnosis
* Patients taking drugs for severe cognitive impairment or psychiatric problems
* Patients who received oral or parenteral corticosteroid therapy for more than 7 consecutive days within 1 month before screening test
* Patients with severe infection, before and after surgery, and severe trauma
* Patients on dialysis at the end of renal failure
* Patients who have a history of substance abuse or alcoholism within 12 weeks through patient history taking, diagnosis records, and past treatment records
* Pregnant or lactating women
* Participating in other clinical trials under R\&D other than this clinical trial, or if other clinical trial drugs are administered within 4 weeks before the trial
* Patients who are using a CGMS/FSGM or who have been using it within 12 weeks
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
19 Years
Maximum Age:
75 Years
Study:
NCT04936633
Study Brief:
Protocol Section:
NCT04936633