WEARABLE DEVICES

 WEARABLE DEVICES 

  Innovation is change that unlocks new value – Jamie Notter

INTRODUCTION:

Wearable’s are used to monitor a user’s health. These are in close contact with the patients so are easy to collect data. From the patient perspective wearable’s will serve to get the patient more engaged which will eventually make them more part of clinical studies. Wearable’s can collect patient health data in real time which makes them part of well suited clinical trials. These wearable’s allows the data to be collected digitally and automatically without having patients to keep any manual records with them. It also allows the patients to not stress much to recollect any information in future. Consumer healthcare wearable’s include fitness trackers, wearable blood pressure monitor devices, digital x-rays, smart phone apps, chest straps, sports watches, patches, and other monitoring sensors that can be worn on the body such as pulse oximeters. These devices make it simpler and easier to collect data on regular basis so that primary diseases can be tracked rightly. Apps and wearable’s are simple and intuitive to use, they make it easier for patients in clinical trials. Such type of technology is bringing the whole research community closer that ultimately benefits the patient. Using these wearable’s, patients do not have to make frequent visits to clinical sites and increases the likelihood to enroll in a trial to be completed on time. Wearable’s include users health data such as heart rate, calories burned, steps walked, time spent exercising, seizures and blood pressure. Wearable devices have more sensors than ever – hearing aid, heart rate, cameras, thermistors, global positioning systems. Apple watch is the best smart watch, but many other kinds of wearable’s have come out, and continue to become apparent.  

Discussion:

The interest in wearable’s has increased considerably since the covid-19 pandemic necessitated a shift away from traditional face to face care options towards remote models of patient care. This pandemic has given the push to consumers and physicians needed to integrate wearable’s into the modern healthcare; ultimately it has turned patients towards telehealth technology and remote care options. The healthcare industry is assessing a variety of wearable’s from factors to address covid-19. This technology can help monitor critical information such as patient heart rate and core body temperature. Smart rings, patches, stamps, and watches are capable of monitoring patients HR, core body temperature, breathing and coughing which is an early symptom of covid-19. Smart watches with digital assistants can help find out users if they have covid-19 symptoms. These wearable’s are becoming important to help enhance bedside care and clinical mobility experience. For example wearable’s worn by patients in hospitals can automatically alert the healthcare staff in real time which has become crucial in context of covid-19 patients where every minute counts. In times of global pandemic these wearables are playing an important role in letting the clinical trials to continue. These devices have greater flexibility in improving the clinical trial to a larger extent that is to meet regulatory requirements.

Benefits:

• Wearable’s provide enough data from patient’s real lives E.g. Capturing walking speed provides a true measure than conducting a 6 minute walk in clinic.

• Sponsors can enhance the trial by looking out for small improvements with time because of data collected.

• Collecting data from patients in their real lives helps to better understand the efficacy and impact of the drug in the real world.

• Data will remain consistent regardless of territory for the use of same health device being used at various sites..

• Data collected at home is highly beneficial since those are real life numbers from patient’s everyday activities.

• Potential improvement of success rate of trials moving from phase 2 to phase 3.

• Despite the global pandemic these devices make it easier for the trials to continue since the data is being transmitted digitally which dodges the need for clinical visits.

• Earlier decision-making by providing access to near real-time data.

• Less clinical site time/personnel.

• Lowering costs and improving effectiveness.

• Reduced participation burden – time and cost savings.

• It is advantageous to patients E.g. Smartwatches not only track heart rate and sleeping pattern but also offer support for people with chronic conditions.

• Patients can monitor and track in quick time intervals or every few hours.

• Help controlling medical expenses by trimming down the cost of clinic visits which in turn reduces treatment and consultation fees.

• Wearable devices and sensors are seen as a way to keep a constant monitor on vitals, in a hospital and outside of a healthcare environment.

Challenges:

• Health insurance portability and accountability act (HIPAA) which controls how protected health information can be shared which accounts for data ownership.

• One of the biggest issues comes while collecting the data required at home that can be discouraging to participants in patient adherence protocol.

• Security and privacy – one of the biggest hurdles that the risks of private patient data being accessed by the public.

• Data validation and data accuracy can be hampered if the patient forgets to wear the device at all times during the trial process.

• Ethical issues, such as gaining approval and ownership over the information generated.

• Batteries- this technology consumes much power, which limits its use and benefits. For Eg. Fit bit trackers can last for several days but apple watches will only last for a day or so which can become a hassle to regularly remove wearable to charge it.

• It is daunting since some wearable devices are known to inaccurately measure the data that can be dangerous when measuring heart rate.

Conclusion:

Wearable technology is challenging and demanding since it has diverse applications as the field expands. Wearable devices is being incorporated not only in healthcare but also in navigation systems and advanced textiles. Because of its sudden spike in popularity, wearable’s have the potential to change our life and society for the better or for the worse.

References:

https://valencell.com/blog/wearables-in-clinical-trials-opportunities-and-challenges/

https://www.imarcresearch.com/blog/using-wearable-devices-in-clinical-trials?hs_amp=true

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6032822/

-By

Neeta Chavan & Sarojini Nair

Students at clinosol