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:
2025-12-26 @ 11:00 AM
Ignite Modification Date:
2025-12-26 @ 11:00 AM
NCT ID:
NCT05594706
Eligibility Criteria:
Inclusion Criteria:
* Type 1 diabetes with positive autoantibodies against islets, insulin, islet antigen 2 (IA2), glutamic acid decarboxylase (GAD) 65 or zinc transporter (ZnT)8.
* Treatment with continuous subcutaneous insulin infusion (CSII) with or without automated insulin delivery (AID).
* Monitoring with a continuous glucose measurement system (CGMS) or flash glucose monitor (FGM).
* Patient willing to keep the same type of CGMS or FGM during the year of observation
* Ability to give informed consent as documented by signature
Exclusion Criteria:
* Patients treated with multiple daily injections (MDI) or not willing to wear a CGMS of FGM
* Patients changing the type of CGMS during the course of the study.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
2 Years
Maximum Age:
18 Years
Study:
NCT05594706
Study Brief:
Protocol Section:
NCT05594706