top of page
  • Saylee Jangam, Des Conroy & Saira Ghafur

From data to insights: evidence for remote monitoring and wearables

Remote monitoring and wearable technologies are promising digital health solutions. To realise their potential, these tools need evidence demonstrating their value to patients, clinicians, and healthcare systems.

Key messages:

  • Remote monitoring and wearable devices, such as smart inhalers and continuous glucose monitors, can revolutionise disease management and improve patient care, particularly in chronic conditions like diabetes, asthma, and COPD.

  • The adoption of remote monitoring solutions is influenced by the availability of robust evidence supporting their clinical effectiveness, cost-effectiveness, and acceptability among end users (patients and clinicians).

  • To fully realise the benefits of remote monitoring, it is critical to evaluate solutions in all of these areas, optimise the services built around them, and provide high-quality education about their use to patients and clinicians.

The rise of remote monitoring

Remote patient monitoring (RPM) refers to the use of digital technologies, including application software, hardware devices, sensors and telecommunications, to gather information about patients’ symptoms and concerns, and transmit this to clinicians who can review the information remotely. These technologies allow monitoring of patients at a distance, such as people with chronic conditions or those recovering at home following discharge from hospital. This can enable timely identification of any clinical deterioration or adverse events, and effective triage of patients requiring in-person clinical review.


Wearables are electronic devices worn on the user’s body (e.g., smartwatches, rings, patches), which measure a range of physiological data, including heart rate, blood pressure, steps taken, distance travelled, floors climbed, sleep quality, calories burned, body temperature and blood glucose. In addition to specific medical devices, a range of consumer wearables are now available (e.g., the Apple Watch and similar products from companies like Fitbit and Garmin). These capture real world data (RWD) and can indicate future health risks, shifting the focus proactively from treatment to prevention. The latest versions of the Apple Watch can detect cardiac arrhythmias and falls, which could be particularly valuable for elderly patients. Meanwhile, biosensors can detect biological markers in blood or interstitial fluid (the fluid beneath the skin that surrounds the cells in the body), in a minimally invasive way using microneedles.


The effects of a global pandemic

While various forms of RPM have been in use for decades, during the COVID-19 pandemic remote monitoring was used more extensively than ever before in many clinical specialties. In the UK, pulse oximetry was approved for at-home self-monitoring of patients with COVID, and early detection of hypoxaemia (an indicator of deterioration) allowed patients to be triaged efficiently. ¹ In the US, the Food and Drug Administration (FDA) also approved greater use of RPM solutions as an emergency measure to minimise hospitalisations and the spread of the virus. In 2023, the FDA issued further guidance for transitioning to the longer-term use of these technologies. ²


Best use cases for RPM and wearables

Remote monitoring and wearable devices are particularly useful in the care of patients with chronic conditions such as diabetes, asthma and chronic obstructive pulmonary disease (COPD). Continuous glucose monitors (CGMs) measure glucose levels in interstitial fluid, and can accurately predict blood glucose levels in near-real time. For patients with diabetes, this ability to monitor blood glucose closely has been shown to enable improved control of the disease. ³⁻⁵ CGMs are revolutionising diabetes care, allowing patients to optimise insulin dosing and their diet to avoid hypo- and hyperglycaemia. This is a great example of how monitoring of biomarkers can be useful in chronic conditions, and this data can be shared with clinicians to help inform decisions about treatment.


In asthma and COPD, compliance and adherence with inhalers is often found to be an issue. Newer ‘smart’ inhalers can increase the probability that patients receive the correct drug dose. They do this by measuring the frequency of use and inspiratory flow rates to calculate the dose received. Smart inhalers can also send medication reminders via a companion app, and even alert patients about a high pollen count or air pollution levels. Information can be shared with healthcare practitioners and could be used to triage patients for clinical review. ⁶


Evidence needed for RPM and wearables, using smart inhalers as a case study

Remote monitoring and wearable technologies are promising digital health solutions. However, as with other interventions, it is important that these tools have robust evidence supporting their use, demonstrating positive impact on patient lives, clinician workflows, and health system finances. For RPM solutions, including wearables that qualify as medical devices, manufacturers need to show that these devices function as intended, and that their use has a positive effect on clinical outcomes. In the case of smart inhalers, over 20 clinical studies examining their use in COPD and asthma have together demonstrated increased adherence, reduced risk of exacerbations, and improved clinical outcomes. ⁶


Beyond clinical value, it is important to show that using RPM and wearable solutions can deliver financial and operational benefits to healthcare systems. This type of evidence can be generated by conducting economic evaluations, such as cost-effectiveness and cost-benefit analyses, to demonstrate value for money and increased efficiency in the system as a result of implementing these tools. Returning to the example of smart inhalers, these devices clearly have the potential to generate cost savings, as we know that suboptimal adherence to inhaled medications among COPD and asthma patients leads to poor clinical outcomes, translating into significant healthcare costs. ⁷⁻⁸ By highlighting poor adherence to maintenance drugs, smart inhalers may inform clinicians that certain individuals could benefit from education aimed at improving inhaler technique. This could lead to direct savings, as clinicians may think twice before moving to more expensive (and higher-risk) second-line therapies, such as biologics in asthma. This could also generate significant indirect savings by improving clinical outcomes in the long run. Despite these known benefits, to date there is a lack of real data demonstrating the cost-effectiveness of smart inhalers and further work needs to be done to assess the economic impact of using these devices.


There is another type of evidence that is critical to give confidence that digital solutions will be effective when put to use in the real world. This is evidence showing acceptability of these tools among end users. In the case of smart inhalers, both patients and clinicians can be seen as end users. Patients may use the devices directly, but the data generated can be shared with clinicians to help inform their decisions. Therefore, both patients and clinicians need to actually perceive some benefit from using these devices, or ultimately they will choose not to adopt or endorse them. A significant part of this “experience value” centres on usability – the overall quality of the user’s experience when interacting with the solution, including ease of use. For digital inhalers, similarly to cost-effectiveness, there remains a lack of published evidence about their acceptability among users. More studies are needed to examine patient and clinician experiences and perceptions. Qualitative methods (e.g., surveys, interviews) are valuable for gathering insights of this type. One thing to consider in optimising users’ experiences with novel technologies is the importance of high-quality education. Both patients and clinicians need appropriate guidance about how to use new digital solutions effectively, and how best to integrate these into their daily routines and clinical workflows, respectively. This is essential to actualise the benefits of these tools.


A blue inhaler connected wirelessly to a smartphone, which has a bar chart on its screen.

Uptake of remote monitoring

Despite significant technological development and the clear potential of remote monitoring solutions, the use of many of these tools remains at a very early stage. In many cases, this is related to a lack of evidence in one, or several, of the areas discussed above. Smart inhalers are a good example of a type of solution for which uptake remains limited despite good clinical evidence supporting their use. As we have seen, more evidence is required to show cost-effectiveness and acceptability among patients and clinicians. Until this evidence is available, their wider use is likely to be restricted.


This demonstrates the breadth of evidence that is required to support widespread adoption of any digital health solution, and in particular higher-risk, regulated devices. These solutions must have proven clinical value, but evidence of operational and financial value, as well as acceptability among users, will in most cases be critical to achieving adoption at scale, and therefore realising their potential for positive impact.


What do digital health solutions need evidence to demonstrate? Clinical value (improved clinical outcomes), financial value (good value for money), operational value (improved efficiency), and experience value (benefit perceived by users.

The future of RPM and wearables

The prospective benefits of remote monitoring are clear. We have seen the potential for solutions to optimise disease management and improve patient outcomes in several chronic conditions. From a health service perspective, the ability to triage patients more effectively, with fewer needing to travel to clinics for review, could save time for clinicians, reduce waiting times, and lessen the overall burden on clinical services. Reduced travel would also save time for patients and lead to more environmentally friendly services.


The adoption of consumer wearables continues to grow. In a 2022 survey conducted in the US and published by Rock Health, 46% of respondents reported owning a wearable device. ⁹ While a large proportion of these are young people in good health (seen as “early adopters''), uptake is increasing among older individuals, with data revealing a gradual trend towards widespread adoption. That current use skews towards those in good health reflects the fact that the vast majority of wearables are still acquired as consumer purchases, rather than devices provided to patients on a medical basis. Despite the overall consumer trend, the use of wearables for specific clinical indications, such as monitoring or managing chronic diseases, remains in the early stages. In most cases, widespread clinical use will require more evidence in many of the areas discussed. As efforts to generate this evidence increase, we can expect to see more partnerships between manufacturers of consumer wearables and traditional healthcare players.


Finally, it will be critical to optimise the services built around these technologies, to ensure that patients receive better care as a result of the data collected. Wearables have the potential to empower patients by putting their data in their hands and allowing them to take ownership of managing their health. However, solutions need to demonstrate real value for patients, clinicians and healthcare systems if all of the key actors are to be persuaded to adopt them. In many cases, patient and clinician education around the use of these tools will be essential to make sure that these users can understand the data collected, and take the appropriate steps to benefit from it.


Prova Health supports digital health innovators with evidence generation. To discuss how we can help with evidence generation for your digital solutions, email hello@provahealth.com


Saylee Jangam is Digital Health Consultant at Prova Health. Saylee is a biosensor and wearables researcher at Imperial College London and holds a BEng in Bioengineering from the University of Sheffield. As part of her PhD, she has led phase I clinical validation of wearable sensors and published results in high impact journals. She has experience with medical device R&D in the FMCG industry.


Dr Des Conroy is a Digital Health Consultant at Prova Health. As a medical doctor, he has worked in clinical practice in the UK and Ireland. He has experience developing and clinically validating artificial intelligence-based Software as a Medical Device (SaMD) products, and supporting their deployment at a global scale. At Prova Health, he has led research into evolving evidence standards and reimbursement models in digital health.


Dr Saira Ghafur is Co-founder and Chief Medical Officer of Prova Health. She is an honorary consultant Respiratory Physician at St Mary’s Hospital, London, and a digital health expert who has published on topics such as cybersecurity, digital health adoption and reimbursement, data privacy and commercialising health data. She is Co-founder of mental health start-up Psyma and holds a MSc in Health Policy from Imperial. She was a Harkness Fellow in Health Policy and Practice in New York (2017).


References:


コメント


bottom of page