Technological advancements have enabled us to access a plethora of information, right at our finger tips. From the energy used in our homes to how we shop, important elements of our everyday lives are now no more than a few clicks away.
Nowhere is this more apparent than in the healthcare sector. Wearables and disease specific apps have enabled us to get a real time insight into certain aspects of our physical condition which can help ease the burden on our hospitals, improves the understanding of diseases and better connects us with our doctors.
One such startup that is pioneering patient monitoring is Wrexham-based aparito. Recognizing the ever-changing challenges to bring new and innovative drugs to patients, the company was founded by Dr Elin Haf Davies, a paediatric nurse by background.
With 20 years of clinical, research and regulatory experience, Haf Davies designed a solution with both the patient and the healthcare provider in mind. She spent much of her time as a paediatric nurse caring for children with rare diseases. She conducted redundant, time consuming and often painful tests in order to monitor each patient’s health. After feeling this method was inefficient she came up with the idea of remote patient real time monitoring.
There are 7,000 rare diseases affecting 30 million people in Europe – 75% of whom are children. Current hospital located assessments however, only provide a snapshot of a patient’s health, and their perspective is not adequately captured and considered by conventional hospital-based tests.
aparito’s solutions can monitor patients individually in their community from the point of care, such as a GP or hospital; use continually collected data to feed into care plans and treatment pathways; and demonstrate real world value as part of the reimbursement process.
A particular area of expertise is in the evolution of orphan drugs (drugs intended to treat diseases so rare that they remain commercially undeveloped).
However, collecting data remotely via wearable devices is not only more convenient for patients and physicians but reduces the element of human intervention that leads to lower data quality. Wearable devices ensure data is constant, consistent, continuous and cost effective, giving researchers a more rounded view of patient symptoms and well-being.
The data, set in a real time and real world context, is gathered effectively and efficiently to deliver a more accurate and meaningful picture of how a treatment works – or disease progresses – on a day-to-day basis. Additionally, by offering wearables that are smaller and more attractive for paediatric patients to wear, aparito can enhance data capture from those younger patients who have traditionally been more difficult to assess.
The company’s wearable devices mean trials can be conducted anytime/anywhere in the world, broadening the scope of the research, meaning drugs and treatments can be developed with reduced up-front capital investment whilst simultaneously undergoing a more thorough validation process. Ultimately, it will lead to paper-free clinical trials.
With direct meaningful data collected from the patient, the process becomes more cost effective for the hospital, health system or insurer and more convenient for the individual. Data captured from an aparito wearable can be set to parameters according to disease manifestation and include heart rate, ambulation, sleep pattern, body temperature, calories, skin temperature and barometric pressure.
Offering a patient perspective not adequately captured and considered by conventional hospital-based tests. Wearables can trigger alerts, empower the patient in disease management, and help inform the clinician in treatment pathway decisions.
From a regulatory perspective, data captured via the aparito system meets Computer System Validation standards, with the safety and efficacy augmented by outcome measures and new data points.
Devices are suitable for patients of all ages, and in particular paediatric patients who are traditionally more difficult to capture consistent and reliable data from because of their tender age – a factor which still leads to a significant number of clinical trials showing inconclusive outcomes.
To overcome this, aparito offers wearables that are smaller and more attractive to wear with a longer battery life and requiring no input from patients. This has proved pivotal in delivering more consistent data, particularly acquired in younger people, from broader disease monitoring and in clinical trials.
By acquiring information from a start and end point, with spikes in data set into context via other parameters, the physician can make a more considered and informed assessment of a patient’s progress. Consequently, this delivers a better understanding of disease and in turn leads to more effective, and personalized, treatment regimes.
Despite being a growth market with worldwide orphan disease sales expected to top $176bn by 2020, sponsors remain reluctant to develop treatments for orphan drugs under normal market conditions, or are hesitant in applying a drug developed for one condition to treat another.
aparito has successfully applied wearable devices to monitor orphan drugs for rare diseases, particularly in paediatric patients. Wearables mean relevant data can be acquired efficiently and cost effectively and help make development of drugs and treatments for rare diseases a more realistic proposition for the pharmaceutical industry.
The company’s UK-based development team offers customers the opportunity to customize their implementation where needed. The internal team specialize in clinical operations and study management, so can deliver a solution tailored to individual requirements.
The aparito platform provides a 360 degree view of the patient with a multi-dimensional approach to data capture. The wearable captures activity data passively (parameters include steps, distance, calories, movement type, skin temperature, ambient temperature, humidity, barometric pressure, heart rate and sleep patterns), while study specific information is collected interactively via the fully configurable smartphone app. These data points can be augmented with environmental indicators to provide a rich data set allowing clinicians to understand the patient context at all times.
The app’s Medication Adherence module also reminds the patient to follow the prescribed treatment protocol and tracks doses taken. Similar to tracking medication, it is important to know if patients are attending regular appointments with their HCP (healthcare practitioner) or if they have needed ad-hoc treatment at any time. The Visits module provides the patient with a quick and easy way to report where they have been, and why.
Individual diseases bring their own challenges. The Events module is fully configurable and allows study sponsors to add a dimension of data capture that can often be correlated with other data points. For example, it has been shown in one of aparito’s ongoing studies that a drop in physical activity for up to 24 hours occurs when a patient reports an actual, or near fall.
Being able to score the quality of life of patients during a study is critical in understanding a range of measures. The PRO (Patient Reported Outcomes) module is fully configurable and through the dashboard, tracks the actual patient outcome scores in addition to measuring each patient against the entire cohort.
At the heart of every study is the insight needed to deliver for the patients of the future and as such, aparito supports customers with a range of reporting and analytic capabilities. The real time dashboard comes as standard with a core study system providing up to date patient and study wide indicators.
As a study progresses aparito can help formulate questions that need answering. The company does this by looking for patterns and correlation with its statisticians or it can use more a sophisticated mechanism such as machine learning tools to conduct disease progression analysis when sufficient data has been collected.
- aparito is being used at the National Institutes of Health (NIH) in the US to investigate the natural history of Gangliosidoses (GM1, GM2). This investigation started in August 2016.
- aparito and Duchenne UK have collaborated on a feasibility study that will recruit patients via two UK centres; Great Ormond Street Hospital, and the John Walton Muscular Dystrophy Research Centre in Newcastle. This started in July 2017.
- Newcastle Upon Tyne Hospitals are using aparito to monitor patients with Juvenile Idiopathic Arthritis between hospital visits in a POC study. This began in November 2016.
- aparito has been contracted by Actelion Pharmaceuticals to monitor patients with Niemann-Pick Type C (NPC). This study began in February 2016 at Great Ormond Street Hospital, and is now also at Central Manchester University Hospitals NHS Foundation Trust.
- The Gaucher Association UK collaborated with aparito to develop a disease specific app for patients with neuronopathic Gaucher Disease to report their own experience of their condition. This was funded by Genzyme and Shire and began in June 2016 at Central Manchester University Hospitals NHS Foundation Trust.
- The Lysosomal Storage Disorder Society collaborated with aparito to investigate remote monitoring of participants with Gaucher disease across India. This user testing spanned a month from January 2016 and initiated again in February 2017.