Using a smartwatch to monitor subcutaneous immunoglobulin treatment in CIDP
Official title: Subcutaneous Immunoglobulin Therapy Effectiveness Monitoring in CIDP Patients Using Smart Devices
Run by Heinrich-Heine University, Duesseldorf · NCT07273903 · Data updated 2026-11-12
This project will test whether smartwatch data like step counts and activity levels can show disease severity and treatment response in adults with CIDP who are switching from IVIG to subcutaneous immunoglobulin (fSCIG).
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 35 (estimated) |
| Sponsor | Heinrich-Heine University, Duesseldorf Academic / other |
| Locations | 2 sites (Düsseldorf, North Rhine-Westphalia and 1 other locations) |
| Status | Recruiting |
| Started | January 15, 2026 |
| Main results expected | January 2028 |
| Study ends | January 2028 |
| Registry record updated | June 10, 2026 |
| Trial ID | NCT07273903 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults (age ≥18) with typical or possible typical CIDP per 2021 EAN/PNS criteria who can use a smartwatch and have recently switched from IVIG to fSCIG or plan to switch during recruitment, with investigator-confirmed stable IVIG therapy before the switch.
✕Probably not a fit
People who cannot operate a smartwatch or smartphone, who are pregnant or breastfeeding, or who have CIDP variants are unlikely to benefit from this wearable-based monitoring approach.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This is an observational study that uses commercially available smartwatches to collect continuous activity data such as step counts and physical activity in adults with CIDP who are switching from IVIG to fSCIG or have switched within the past six months. Collected wearable metrics will be compared with standard clinical scores for inflammatory neuropathy to see if device data reflect disease severity and changes after treatment. Participants will use the smartwatch at home while receiving routine fSCIG care, and clinical visits at university hospitals will provide reference measurements. The study is being run at two German academic centers to capture real-world, between-visit variability in function.
Why it matters
Potential benefit: If successful, smartwatch monitoring could provide continuous, objective measures of function that help detect small changes earlier and better personalize immunoglobulin dosing.
How similar studies have gone: Wearable monitoring has shown promise in other neurological conditions but applying smartwatch activity data to track treatment response in CIDP is relatively new and not yet well established.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 Exclusion Criteria: * Age \< 18 years * Inability to operate smartwatch or smartphone device * current pregnancy and breastfeeding status * CIDP variants according to the 2021 EAN/PNS criteria
Where it's running
-
University Hospital Düsseldorf
Düsseldorf, North Rhine-Westphalia, Germany Recruiting -
University Hospital Münster
Münster, North Rhine-Westphalia, Germany Recruiting
Study contacts
- Principal investigator: Marc G Pawlitzki, PD Dr. med. — Department of Neurology, Heinrich-Heine University, and University Hospital Duesseldorf, Germany
- Study coordinator: Marc G Pawlitzki, PD Dr. med.
- Email: neuro-trials@med.uni-duesseldorf.de
- Phone: +49 02118117887
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.