The use of mobile technologies (such as smartphones, tablet computers, and portable, implantable, or wearable medical devices), known collectively as “mobile health” or “mHealth” devices present a wide array of challenges and opportunities for medical research. There is much to be learned about how well these devices work, their validity and reliability. While these devices hold abundant promise, they are imperfect measures and are not commonly used in clinical trials (Clinical Trials Transformation Initiative 2016). For example, if a participant is wearing an activity monitor and claps at a concert, it is possible that the device could record this as running? Or, will a geo-spatial device record running on a treadmill as activity at all?
Some examples of the utility of these devices include:
- A PCT can be designed where a patient has an application (app) for their phone that provides passive or active surveillance. For example, an app with geo-sensing can ping a person who enters the hospital with the question: Why are you in the hospital? Or Are you ill?
- Some mHealth devices will transmit data about a participant’s health status to a data warehouse every night. The devices can measure physiologic functions, such as how active a person is, heart rate, etc. As a hypothetical example in a PCT designed to evaluate how to prevent cardiac death, a patient could wear a heart monitor that detects arrhythmias and other heartbeat abnormalities, as well as whether or not a patient is hospitalized.
- Patients with type 1 diabetes can use continuous glucose monitors (CGMs) to monitor their blood glucose levels, and this information can be sent to a smartphone, and CGM-specific receiver, or an insulin pump (Clinical Trials Transformation Initiative 2016).
The Clinical Trials Transformation Initiative (CTTI) held an expert meeting to develop novel endpoints generated by mobile technology for use in clinical trials in November 2016. Some recurring themes from the meeting include:
- Patients and their needs should be the starting point for developing novel endpoints
- The device selected should be optimal for the patient population
- Novel mHealth endpoint data should be used in conjunction with more established endpoints to establish the reliability and validity of mHealth endpoint data (Clinical Trials Transformation Initiative 2016)
Meeting participants developed four hypothetical use cases for endpoints using mHealth technology:
- “Physical activity level and gait, measured using an accelerometer, as an endpoint for Parkinson’s disease
- Physical activity level, measured using an accelerometer, as an endpoint for heart failure
- Blood sugar level, measured using a wearable continuous glucose monitor (CGM), as an endpoint for diabetes
- Physical activity level, measured using an accelerometer, as an endpoint for muscular dystrophy (Clinical Trials Transformation Initiative 2016)”
Clinical Trials Transformation Initiative. 2016. Developing Novel Endpoints Generated by Mobile Technology for use in Clinical Trials. https://www.ctti-clinicaltrials.org/projects/novel-endpoints. Accessed July 24, 2017.