Medical Devices

How can the Internet of Things Help Design a Patient-Oriented Clinical Trial? – Part I

Medical Devices

10:00, October 16 2017

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In a two-part exclusive, Francis Plat, Milestone Pharmaceuticals, examines the role of the internet of things in clinical research

What is the Internet of Things?

The Internet of Things (IoT) is defined as physical devices that are instrumented to capture and transmit data covering everything from environmental conditions to usage patterns and user behaviors.[i] It is considered the next wave of information technology advancement.

The development of fitness IoT gives individuals the opportunity to manage their health by establishing and following a diet, setting up and monitoring physical exercise programs. Wrist-worn fitness and heart rate monitors are popular because they can provide data to individuals helping them to follow-up training and record simple health datapoints like heart rate variation with exercise or blood pressure.[ii]

These devices are proposed at a reasonable price for recreational use, and they generate adequate data to fulfill the customer’s needs. Recent studies have shown that the accuracy of the measurements is variable across the devices especially in the higher and lower end of the variable ranges. This variability is acceptable if there is no critical health issue at stake, but the requirements are different when the device provides data that could influence the patient or physician disease management.

What is the contribution of IoT in the medical management of diseases?

Medical IoT are devices designed to provide data helping for the diagnosis or the management of a disease. The device detects and records key digital signals that are converted by software and transmitted to the patient and or the physician to help diagnosis or therapeutic decision-making. The device should meet a predefined standard of reliability and accuracy, and must be approved by the FDA and be HIPAA (Health Insurance Portability and Accountability Act) compliant.

In the cardiovascular arena, several devices have been developed to monitor biologic markers or detect some critical predictive data. The management of heart failure based on a home transmission of pulmonary artery pressure with an implanted pressure sensor showed a significant long-term benefit in lowering hospital admission rates for heart failure.[iii] It is now possible to monitor an electrocardiogram for a long period to detect arrhythmia or conduction issues. The current cardiac monitoring systems (CMS) are now like patches, easy to put on the chest. The battery life is long enough to cover several weeks, and the limitation is more related to the local intolerance to the adhesive than the device itself, some devices are proposed with dry electrodes and can be connected to a belt around the chest. Some insertable devices have up to three-year longevity for long-term monitoring of several episodes, but they have limited total storage capability, generally less than one hour, and thus some arrhythmias may be missed.

P. Zimetbaum and A. Goldman recently described the various types of devices to be used in different circumstances.[iv] Ambulatory monitoring has been widely used since the first Holter monitor was released for commercial production in 1962. For long the battery life and the recording capabilities were limiting the diagnostic capabilities for rare and unexpected events. The new technologies of batteries and memory cards dramatically changed the performances of these devices. Atrial fibrillation (AF) has become an increasingly important indication for ambulatory monitoring, predominantly as a tool to monitor the efficacy and safety of pharmacological and nonpharmacological therapies. It is also used to identify asymptomatic AF as a potential source of cryptogenic stroke. The superiority of long-term monitoring versus 24-hour Holter monitoring in detecting meaningful arrhythmias has been proven in several randomized clinical trials.[v]

External Loop Recorders (ELRs) can be activated by the patient in case of symptoms or automatically triggered by slow, fast, or irregular heart rates. ELRs are event recorders with a ‘loop memory,’ i.e., they continually analyze the ECG and retain information about relevant arrhythmias that are automatically detected thanks to predefined algorithms. The device or memory card can be sent to a central reading core laboratory or downloaded and transmitted directly through the internet with a smartphone, depending on the size of the files. Some devices identified as Mobile Cardiac Outpatient Telemetry (MCOT)[vi] can automatically transmit arrhythmic event data from ambulatory patients to an attended monitoring station. Several studies demonstrated the superiority of MCOT over the standard of care for the patient's benefit.

How can IoT contribute to Clinical research?

Device reliability, accuracy, and reporting need to satisfy the needs of clinical trials especially if the primary endpoint depends upon the signals obtained with the device.

We at Milestone are currently developing a new drug to be self-administered to terminate symptomatic episodes of paroxysmal supraventricular tachycardia (PSVT). For the time being, if the episode is prolonged, the patient needs to go to a clinic or an emergency room to receive an intravenous therapy (adenosine or verapamil) under medical supervision. We want to establish a new treatment paradigm by which the PSVT patient will take control of the episode of supraventricular tachycardia (SVT), i.e., self-identify the symptoms related to SVT, to make the decision to self-administer the drug and terminate the tachycardia. The clinical development should provide evidence of efficacy and safety in the “real-world” conditions of use.

It is acknowledged that the documented proof of the SVT, its termination, and conversion to sinus rhythm is an appropriate endpoint demonstrating the efficacy of the self-administration of the drug. An ambulatory cardiac monitoring system is a logical approach, and it should permit to collect evidence of efficacy and cardiac safety of this new paradigm. The choice of the device and the organizational aspects of the collection, interpretation, and archiving of the data need to be predefined. We asked ourselves the questions listed by P. Zimetbaum and A. Goldman in their article to identify the CMS that best addresses the specific needs of this investigation.

 

*In the second part of this article, Francis Plat will provide a case study exploring the effects of a self-administered drug designed to detect SVT. Click here for the conclusion of this article

 

Francis Plat

Chief Medical Officer

Milestone Pharmaceuticals

 

References:

1) https://www.cognizant.com/whitepapers/how-the-internet-of-things-is-transforming-medical-devices-codex1945.pdf

2) Wang R, Blackburn G, Desai M et al.Accuracy ofWrist-Worn Heart Rate Monitors.JAMA Cardiology 2017;2, Number 1

3) Abraham WT, Adamson P B,  Bourge Robert C, et al.Wireless pulmonary artery hemodynamic monitoring in chronic heart failure: a randomized controlled trial (the CHAMPION trial). The Lancet 2016;387;1017, 453-61 DOI:http://dx.doi.org/10.1016/S0140-6736(15)00723-0

4) Zimetbaum P, Goldman A.Ambulatory Arrhythmia Monitoring, Choosing the Right Device. Circulation2010; 122:1629-1636.

5) Barrett P, Komatireddy R, Haaser S et al.Comparison of 24-hour Holter Monitoring with 14-day Novel Adhesive Patch Electrocardiographic Monitoring. The American Journal of Medicine 2014,127; 1, DOI: http://dx.doi.org/10.1016/j.amjmed.2013.10.003

6) MCOT is a trademark of CardioNet, Inc.

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