The use of SMART technology in the management of respiratory disorders

According to the UK National Institute of Health and Clinical Excellence (NICE) ‘Impact respiratory conditions report‘ of July 2020:

Respiratory diseases affect 1 in 5 people and are strongly associated with social deprivation. They:

  • Cost the NHS £9.9 billion each year
  • Are the third largest cause of death in the UK
  • Lead to 850,000 emergency admissions a year
  • Led to 4.9 million day spent by patients in hospital in 2017/2018
  • Lead to 80% more hospital admissions in winter

Based on the stats above, it seems quite clear that much work remains to be done yet in order to see any significant improvement in the outcomes associated with these conditions such as a substantial reduction in emergency admissions or mortality.

Some of the challenges that continue to remain unresolved for conditions such as asthma and COPD include:

  • Ensuring that the diagnosis is correct
  • Correct inhaler technique
  • Adherence/Compliance with treatment
  • Elimination of trigger factors for acute attacks
  • Understanding when to use reliever and preventer therapies
  • Re-educating patients at intervals about all of the above once treatment has commenced

It is very encouraging to see that a number of companies are already extending the boundaries on how to better manage these conditions and to address the above challenges and others, with the assistance of SMART technologies plus the use of Artificial Intelligence powered digital health tools. They provide a range of products available with the appropriate approvals via CE marking or US FDA 510(k) approvals. Further information on such products is provided later on in this post.

One obvious question might be that if  such products are already available, what is preventing them from being used at scale? The answer to this question is not simple. As with all such questions, the devil is always in the detail. One might reasonably assume that if a medical device has been granted a CE mark that it can immediately be marketed in the UK and used by the NHS. As it turns out, this is not the case.

  • As this article on the NHS website explains, to market a medical device effectively,  its clinical efficacy with evidence from pre- and post-market clinical trials must be demonstrated.
  • Pre-market studies, known as clinical investigations, are performed to gain safety and performance data. This is used to demonstrate compliance with the regulations for placing devices on the European market (CE marking)
  • Post-market studies are where the device already has market approval (CE mark) and is being used for its intended purpose as part of a clinical study. The aim is to produce data that can support the manufacturer’s claims of device performance, clinical and cost effectiveness and benefits to patients
  • Conducting such studies is resource intensive and only if the outcomes are satisfactory, is it possible to contemplate the idea of the use of the product by the NHS. However, this is only one part of the story.

Some of the challenges and opportunities of using SMART technologies
In 2017, a report entitled ‘Smart Asthma, Real-world implementation of connected devices in the UK to reduce asthma attacks’ was published. This is quite a comprehensive report detailing  the opportunities and challenges with SMART or connected devices . It seems there is eagerness on the part of clinicians, patients and others for these technologies to be introduced at scale, but there are considerable challenges that need to be addressed before such an introduction can happen. Some of the challenges are:

  • As SMART devices become increasingly prevalent, clinicians will need to adapt to use the data collected as a core part of their assessment and monitoring of patients
  • Different approaches to procurement will be required as commissioners will not just be purchasing prescription medicine inhalers, but also other components to make the whole system work such as e.g. sensors, cloud services, user mobile apps and clinical support systems. How these are priced and sold from the outset could have far-reaching impacts on models of implementation
  • Little work has been done to determine how apps and devices will link to NHS systems in a standardised manner and make interoperability the norm. This is crucial in order for the data gathered to be used to make clinical decisions or to automate management steps. There must also be the scope to also be able to switch between inhaled treatments (or use multiple treatments) seamlessly, without being tied to a particular mobile health offering or needing multiple apps.
  • Realising the potential of connected technologies requires investment in a significant  research programme to obtain basic information such as accuracy, robustness, user experience and clinical outcomes.
  • As these technologies will no doubt generate very large amounts of data in a continuous stream, healthcare providers need to plan how the data will be stored and meaningfully integrated into electronic patient records and establish who owns the data
  • There is no clear national strategy for the adoption of connected devices and the evidence base underpinning best practice lags significantly behind technical capability

How the above and other challenges will be resolved and time frame for their resolution remains unclear.

According to the report, SMART inhalers have the potential  to support the NHS in many different ways including the following:

  • Digital transformation of health services
  • Management of long-term conditions at scale
  • Enhanced supported self-management
  • Personalised approaches to care
  • Reductions in avoidable emergency admissions

At a time when the NHS it stretched to its very limits on resources, it seem that there could be no better time than the present to gradually start the introduction of SMART technologies to better manage respiratory diseases and reduce the burden on the health service whilst ensuring that patients become active partners in the management of their conditions.

SMART product technologies
The SMART products on offer have a mix of technologies and include some or all of the following:

  • Sensor(s) either integrated within an inhaler or  device with sensor(s) fitted on inhalers or spirometers
  • Mobile apps
  • Bluetooth connectivity between the sensors and the mobile apps
  • Cloud services
  • Artificial Intelligence (AI) driven digital health tools
  • Clinical support tools

Some of the capabilities of the products include:

  • Providing daily dose reminders
  • Logging daily use of inhaler medication
  • Providing information on daily pollen count
  • Reminding patients if they forget to take their inhaler with them to work, school etc.
  • Ability to share usage data with the patient’s health care team and this can impact patient healthcare in many ways including e.g. reduced visits to a clinic or the ability of a healthcare team to proactively intervene in a patient’s treatment in a timely manner to prevent a condition from worsening
  • Spirometer connected to a sensor – Delivers insights into how patients’ lung health is developing overtime so that physicians can proactively make the most appropriate clinical decisions

Companies and their SMART product offerings
Information on a small number of companies and their products is provided below. The list is by not means exhaustive.
Of the companies listed, Teva a pharmaceutical company is the only company which appears to have its own in-built electronic module with sensor. Novartis Europharm Limited has a slightly different offering i.e. it has a prescription medicine inhaler which is packed with a sensor from the digital health company, Propeller Health. The rest of the companies are all digital health companies. It seems that digital health companies engage in tie ups with pharma companies by providing individual sensors to be used with individual prescription inhaler products.

1) Company:
Teva

Product
PROAIR®DIGIHALER
Inhalation powder, for oral inhalation use (contains albuterol sulfate)

Licensed indications:
Proair digihaler is a drug product containing a beta2-adrenergic agonist indicated for:

  • Treatment or prevention of bronchospasm in patients 4 years of age and older with reversible obstructive airway disease.
  • Prevention of exercise-induced bronchospasm in patients 4 years of age and older

Further information:
According to the prescribing information the product includes:

  • A built-in electronic module which detects, records, and stores data on inhaler events for transmission to mobile

The product website states that the product has:

  • Sensors which detect how often the inhaler is used and measure inspiratory airflow
  • Built-in Bluetooth technology which after pairing with the mobile app, automatically sends inhaler use information to it.

Daily and weekly reports can be shared with caregivers and healthcare providers

Approvals:
US FDA registered prescription only medicine

 2) Company
FindAir

Product:
FindAir ONE

Product type:
Smart sensor

Approvals:
CE marked

Further information:
According to the company website, FindAir ONE:

  • Is an innovative product built in collaboration with leading European Pulmonologists
  • Can be used by patients with asthma or COPD
  • Should be attached to a rescue inhaler and the FindAir App (subscription based) dowloaded onto a mobile phone
  • Will work seamlessly in the background by itself when a rescue inhaler to which it is attached is used used as normal,
  • Connects via Bluetooth technology to the specially developed FindAir app
  • Collects the most important information about the history and circumstances of each use of the rescue inhaler and helps a doctor to understand what causes a patient’s exacerbations and how to avoid them in the future
  • Provides notification on a mobile phone when an inhaler is accidentally left at home, school or office
  • Is compatible with a number of  inhalers and a list is provided

A patient can look through all the collected information in the FindAir App and it will tell them what to pay attention to i.e. is it the grass pollen, poor  air quality etc.  that causes most of  a patient’s symptoms?

3) Company
Adherium Hailie – A global leader in digital health technologies which address sub-optimal medication use in chronic disease.

Products:
Smart sensors

Approvals:
The sensors have US FDA 510(k) clearances:

K181405

K182573

K182638

Further information:
According to the company website:

  • The Hailie™ solution which is an ecosystem of devices with sensors plus apps that help patients and health specialists manage respiratory conditions and medications. It provides people who live with asthma or COPD with the tools to help manage their condition and empowers them to take control of their health day by day.
  • The Bluetooth wireless technology-enabled Hailie™ medication sensors wrap around patients existing inhalers and automatically send usage data to their smartphone.
  • Using the Hailie™ mobile app enables the patient and health care professionals to track medication adherence, set daily reminders, and discover insights into their medication usage.
  • There are Hailie™ sensors available to fit a range of inhalers to help keep track of inhaler use.
  • Currently,  there are a number of sensors available, each one to fit on a specific inhaler.

4)  Company:
Propeller Health – A leading digital health company dedicated to the management of chronic respiratory disease

Products:

Smart Sensor:
Enerzair® Breezhaler® (a Novartis Europharm Limited product) and Propeller sensor and app received approval from the European Commission in July 2020 and will launch across Europe starting in 2020. This collaboration marks the first time a digital health tool will be packaged and prescribed alongside an inhaled asthma medication.Inhalation powder, hard capsule (contains Indacaterol, Glycopyrronium bromide and Mometasone

Licensed indication for Enerzair® Breezhaler®:
Enerzair Breezhaler is indicated as a maintenance treatment of asthma in adult patients not adequately controlled with a maintenance combination of a long-acting beta2-agonist and a high dose of an inhaled corticosteroid who experienced one or more asthma exacerbations in the previous year.

Note: The sensor is packed with the medicinal product and is CE marked.

Integration of mobile and clinic based spirometers into the Propeller Platform

Propeller Health and Medical International Research (MIR), a global leader in spirometry, oximetry and telemedicine have a collaboration to integrate several of MIR’s mobile and clinical spirometers into the Propeller system. Healthcare organizations and pharmaceutical partners using Propeller can incorporate MIR’s spirometers into their clinical and commercial programs, thereby adding another important signal in the digital management of patients with asthma and COPD. Data from these devices will be automatically routed to the Propeller platform where patients and physicians can evaluate their status.

Approvals:
EU registered prescription only medicine which includes a propeller sensor

FDA 510(k) clearances  (Click to the link and type ‘Propeller’ in the section ‘device name’ to get a full list of products with 510(k) clearances

CE Marked and Health Canada registration

Further Information:
According to the company website:

  • A Propeller sensor is attached sensor to a patient’s inhaler
  • Provides daily reminders for when to use a medicine and information about air quaily
  • Helps patients to understand what may be causing their symptoms, so that they can live a more active life
  • Enables patients to share important information with their families and health care teams
  • Propeller sensors work with over 90% of inhaler medicines available in the US
  • Air by Propeller is a set of free tools to help people understand current asthma conditions in their neighborhoods.
  • Air also includes a series of tools that share local asthma conditions.
  • Air tools are built from the Air API and range from an email or text subscription, to an embeddable Air Widget for other websites.

5) Company
Amiko Digital Health – Designs and manufactures medication sensors. The Company develops and supplies sensor technologies and artificial intelligence (AI) powered mobile health solutions to assist healthcare professionals and patients to achieve better outcomes

Products:
Respiro sensors

Approvals:
CE marked for use with specific inhalers.

Further information:
According to the company website, Respiro:

  • Is an approved and clinically validated digital medicine product that combines connected inhaler sensors, digital applications, behaviour change programs and predictive analytics to personalize respiratory treatment
  • Sensors track when and how well patients use their inhalers, and generates personalized inspiration profiles to help monitor disease progressio
  • Mobile patient app provides personal patient feedback
  • Cloud integrates with web platforms and EMR (Electronic Medication Record)  systems
  • Vision provided portal provides data insights and predictive analytics

6) Company
Nuvoair

Product:
AirNext Portable sprirometer,

Approvals:
US FDA 510(k) clearance

Further information:
According to the company website, Nuvoair:

  • Respiratory platform is designed to assist patients and physicians in preventing clinical deterioration from respiratory exacerbations. Combines a personalized asthma management plan with lung function measurement to support patients in managing their asthma more effectively
  • Delivers insights into how patients’ lung health is developing overtime so that physicians can proactively take the most appropriate clinical decisions
  • Incorporates air quality and weather data to advise patients to pay extra care when going out. The early stages of worsening in Asthma control could be detected by personalised algorithms.
  • Collects mMRC, lung function data and activity levels in patients with COPD. Although, pulmonary rehabilitation is effective in inducing behavioural change to encourage patients to be more active, access and availability is limited; self-management program, using a smartphone app, can be an effective substitute in patients with COPD
  • Allows patients to track their lung function, Cystic Fibrosis symptoms  and weight changes and to understand how their condition progresses over time. Personalized algorithms inform healthcare professionals and patients when their condition is deteriorating so that the appropriate action can be taken.

Update on 17/08/2020
Asthma UK recently launched a £250K funded competition for the planning and design of a trial to answer the research question: Can data generated from smart inhalers be used to reduce emergency healthcare use in adults with mild-moderate asthma as part of UK routine asthma care? The competition is now closed.
Other such initiatives will no doubt be required to answer the relevant questions so that SMART devices can be introduced by the NHS for use at scale in the community.