Wearable Devices in Clinical Trials

By: Sofia Jacob, Project Manager

Wearable devices have become part of our day-to-day lives. We can track our steps, monitor our sleep, and record our heartrate very easily with smartwatches, chest straps, or by simply using our smartphones. Most of us use these devices to motivate ourselves to stay active, but wearable technologies are also a key instrument of healthcare innovation. For instance, the Innovative Medicines Initiative (IMI) IDEA-FAST is a clear example of how wearable devices can have a major impact on patients’ lives.

The aim of this consortium is to Identify Digital Endpoints to Assess FAtigue, Sleep and acTivities of daily living (acronym: IDEA-FAST) in neurodegenerative disorders and immune-mediated inflammatory diseases. Fatigue and sleep disturbances are common and disabling symptoms that affect patients with these chronic diseases and are the major predictors of poor quality of life. Current questionnaire-based approaches to measure these symptoms have key limitations, such as recall bias, reliability issues, and poor sensitivity to change, preventing them from being used as reliable endpoints in clinical trials to evaluate the effect of therapies. IDEA-FAST wants to change this by identifying novel digital measures for fatigue and sleep disturbances that will provide more objective, sensitive and reliable measures of the severity and impact of these symptoms in the patient’s normal surroundings.

This 66-months project consists of two phases: an initial feasibility study for testing and prioritizing several digital devices and to identify candidate digital endpoints, followed by a large clinical observational study to validate findings for the most promising digital endpoints. Now, 16-months into the project, IDEA-FAST is more than half-way through the data collection of the feasibility study. Participants in this study include patients with Inflammatory Bowel disease, Systemic Lupus Erythematosus, Rheumatoid Arthritis, primary Sjögren’s syndrome, Parkinson’s disease, and Huntington’s disease. The participants use a combination of different digital devices such as Dreem, McRoberts BV, BedSensor developed by VTT, Byteflies, and Vitapatch from MidiBioSense over a period of four weeks while simultaneously reporting fatigue and sleep disturbances.

After analyzing the feasibility study results, the IDEA-FAST consortium will start the one-year longitudinal clinical study with the most promising digital devices with approximately 2000 participants. After completion of the two phases, IDEA-FAST hopes that these novel clinically validated digital endpoints would lead to faster clinical development of new therapies.

 

About the Innovative Medicines Initiative and the European Federation of Pharmaceutical Industries and Associations

IMI is Europe’s largest public-private initiative aiming to speed up the development of better and safer medicines for patients. IMI supports collaborative research projects and builds networks of industrial and academic experts in order to boost pharmaceutical innovation in Europe. IMI is a joint undertaking between the European Commission and EFPIA.

See https://www.imi.europa.eu/  and https://www.efpia.eu/for more details.

Acknowledgement

This project has received funding from the Innovative Medicines Initiative 2 Joint Undertaking under grant agreement No 853981. This Joint Undertaking receives support from the European Union’s Horizon 2020 research and innovation program and EFPIA.

 

Blogpost Wearables

Disclaimer

This communication reflects the view of the IDEA-FAST Consortium and neither IMI nor the European Union and EFPIA are liable for any use that may be made of the information contained herein.