Subcutaneous Immunoglobulin Therapy Effectiveness Monitoring in CIDP Patients Using Smart Devices
Design: This is a 12-month observational study with five main clinic visits (at 0, 3, 6, 9, and 12 months). After enrolling, participants will begin or continue subcutaneous immunoglobulin therapy as decided by their treating physician. Each visit includes standard clinical assessments and questionnaires. Participants will receive a smartwatch at the start of the study to continuously track their activity and sleep patterns. A follow-up phone call one week later will check that the device is working properly. Duration: Recruitment will last about 6 months, and each participant will be followed for 12 months. Why This Matters: By combining established clinical measures with continuous digital monitoring, the S.T.E.P.S. study may help improve understanding of disease activity and treatment response in CIDP. This could lead to more personalized therapy schedules and better long-term care for patients.
• Diagnosed typical or possible typical CIDP according to the 2021 EAN/PNS criteria
• Age ≥18 years
• Ability to use a smartwatch as decided by the investigator
• switched from IVIG to fSCIG within the prior 6 months or plan to switch during study recruitment phase
• on investigator-confirmed stable IVIG therapy pre-switch