Activinsights and Cardialysis Announce a New Strategic Partnership

Activinsights is excited to announce a new partnership agreement with Cardialysis, a leading Cardiovascular Research Organisation with an exclusive focus on cardiology.

This new collaboration will see Cardialysis become the first organisation of its kind to promote the use of remote monitoring wearables as a tool for researchers to better understand the daily lifestyles of their patients.

By using Activinsights’ professional wearable devices, Cardialysis will be able to accurately understand their patient’s behaviours and monitor behaviours such as sleep, sedentary behaviour, walking and high activity levels, as related to cardiology. By collecting this in-depth raw data, sponsors will be able to analyse and understand how certain treatments and interventions may be affecting the patient.

Dr. Ernest Spitzer, Chief Medical Officer at Cardialysis commented, “The use of professional wearables in clinical research brings us a step closer to understanding how new therapies effect the day-to-day symptoms of trial participants. As much as traditional clinical outcomes remain a priority for effectiveness and safety assessments, incorporating actigraphy into clinical research may become a new standard for the short and mid-term evaluation of cardiovascular therapies”.

An active lifestyle is pivotal to remaining healthy and is important for smooth recovery after periods of disease. In cardiology, however, most conditions are chronic, meaning that once a patient is diagnosed, the disease will progress unless treated. These cardiac conditions may affect the patient’s ability to exercise or even perform daily activities. Therapies based on devices or drugs can improve symptoms and quality of life, and actigraphy is a modern method to assess these changes.

“Three conditions where the use of actigraphy becomes immediately evident are heart failure, structural heart disease, and coronary artery disease, especially in comparisons between surgical and transcatheter interventions,” commented Dr. Spitzer.

Bill Hogan, Activinsights’ CEO also expressed his delight in this new partnership – “We are very excited about this collaboration. The opportunity to work with Cardialysis to offer our professional wearables will be of huge value to clinicians and researchers as they assess patient behaviours. With the move towards decentralised trials accelerating, patient remote monitoring is now critical, particularly for long-term deployment, so this relationship will be significant to cardiology patients going forward”.

Activinsights’ technologies have been successfully deployed within cardiology trials and studies for many years. This collaboration between Cardialysis and Activinsights supports trials in gaining additional objective digital measures outside of the clinical environment. The ability to understand a patient’s quality of life remotely, along with supporting clinical endpoints such as the 6-minute walk test in a free-living environment, will continue to innovate the market. Activinsights’ high-quality data goes beyond traditional actigraphy and enables the development of relevant digital biomarkers within cardiovascular disease research.

This partnership steers towards an exciting future in supporting cardiology trials, with an overall goal to improve health outcomes for many patients.

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About Cardialysis
Cardialysis is a leading Cardiovascular Research Organization with an exclusive focus on cardiology, providing the full range of clinical research and cardiovascular core laboratory services. Through almost 40 years, Cardialysis has executed over 400 clinical investigations, and contributed to advances in the management of cardiovascular disease ultimately improving clinical outcomes and quality of life. Its largest contribution relates to clinical investigations with cardiovascular devices, such as coronary stents and transcatheter heart valves; nevertheless, the organization has also managed some of the largest and most innovative drug trials in interventional cardiology and heart failure. Cardialysis is recognized for its key-opinion-leader network, strong academic involvement, and in-depth methodological expertise. In the past decades, Cardialysis has developed full-service clinical operations capabilities, which in combination with its academic and core laboratory services, allow to plan and execute a clinical investigation from the design phase up to the reporting of the study results.

About Activinsights
Activinsights is a digital health company that specialises in the objective measurement of physical behaviours and lifestyle. Our technologies are used worldwide within the clinical trials, health management and research markets to provide accurate and continuous monitoring of lifestyle outside of the clinic environment. We develop novel health measures from data collected by our own professional wearables and other connected devices, such as phone apps, within a scalable global and secure infrastructure. Advanced data analytics reveal insights, novel endpoints and biomarkers that support pharmaceutical drug development, clinical practice, and disease management.

For more information, contact:
Raghbir Bains PhD
Commercial Director, Activinsights
raggyb@activinsights.com
+44 (0)7496 292 073

Getting Closer to the World of the Patient with Internet of Things Thinking

A technology perspective on how we can use the Internet of Things to better serve patients in clinical trials
Joss Langford, CTO & Founder of Activinsights.

So, what exactly is the Internet of Things (IoT)? IoT products can be defined by having four characteristics:

IoT products and services can be used to simplify the remote collection of health data for patients, practitioners, and researchers. Here we will look at some of the ways in which we can change our thinking to better understand our patient’s needs and how we can alter our methods to ultimately produce better outcomes and reduce burden for the patient.

Changing our Thinking

IoT thinking is transformative – it helps us change our way of thinking to better understand our patients’ everyday environment, behaviours and needs. Data from IoT products can come from everywhere and anywhere. We must go beyond being patient-centric to being human-centric and look at the world from the viewpoint of the patient. For example, when clinical trials refer to ‘remote monitoring’, for a patient it is ‘monitoring at home’. Early in protocol development, using human-centric design will help us to understand the environment of the patient and view them as an individual first and as a patient second – patients want to live an everyday, normal life and not just be defined by their diseases.

Using Standardised Approaches

Standardised approaches help to reduce risk, cost and development times. Many of the most useful standards are not formal or technical. They can be as simple as using a normal watch strap on a wearable – something people are used to using in everyday life – to reduce cognitive burden and the need for instructions. These are known as de facto standards.

Formal technical standards allow interoperability between modules in a system, giving substitutability and preventing vendor lock-in. However, there will always be compromises to be made between what can be standardised and what must be bespoke.

Staying Connected

The strictest definition of an IoT product requires that it is discoverable and addressable on the Internet. In our studies, we probably don’t want products to be universally discoverable and we don’t need them to be permanently connected.

But how much ‘real-time’ connectivity is really needed?

Near real-time management and quality data can support study risk control, but only if they are actionable. We often see this when measuring non-wear – we are keen to understand how successful we are at deploying technologies but if we can’t do anything to change this once the study is in progress, then we may be adding a real-time measurement burden that we cannot action.

Real-time, continuous measurement is clearly a transformative aspect of home-based approaches and can really make a difference in our studies. While digital interventions may fundamentally need real-time data, in most measurement studies the perceived need for the timeliness of data must be balanced with the power and infrastructure requirements it brings.

Power & Infrastructure

Real-time is not free as connectivity needs both power and infrastructure. Power requirements will impact product size or the need for at-home charging. The size of a product may impact acceptability and having to remember to charge is another burden for the patient. Once the patient has the need to remove a wearable product, they are much more likely to forget to put it on again, reducing adherence.

When we insist on using infrastructure that we don’t need, we risk exacerbating technology bias. That might be because were excluding people through their digital literacy or their social economic status or geography. The levels of interconnectivity vary massively between rural and urban populations. We find that carefully defining the digital cadence of a study before specifying real-time requirements helps to resolve many of these questions.

Sensing

We need to recognise that IoT products in clinical studies author personal data automatically. This has profound impacts on how we think about managing that data. The data are behavioural and describes what the patient actually does rather than what they say they do, so we have an increased responsibility to explain exactly what they are sharing. These data are also transformative, but risks of privacy are obvious, and we need to consider trust as a potential patient burden.

Personal Data Principles & Rights

When it comes to personal data, there are regulations that vary by jurisdiction, but the principles and rights are reasonably consistent. One of the challenges is around the management of privacy. We must be very careful that when we use pre-scaled technologies, we clearly understand their pre-defined data flows and business models and ensure they’re compatible with our aims.

As we develop more digitally-enabled systems, individuals start to expect that if they can express consent or sign-up digitally, they should be able to exercise their rights digitally. We need to manage expectations and use this as an opportunity to create trust with our patients.

Sensor-Level Data Computing

Once the on-product software (known as firmware) has done the basic job of managing the product, it can then convert sensor-level ‘raw’ data into digital measures using algorithms.
These outputs may be meaningful health measures in their own right or they may become features in statistical or machine learning models.

Behavioural events can then be identified, characterised and their classification understood. This includes:

At this level of algorithm development, sensor-level data are an essential resource for us to be able to create novel, verified algorithms that we can turn into digital health measures for validation.

Computing at the Edge

Once we understand the algorithm requirements, we can use a technique from the IoT space called ‘edge computing’. This means that we are going to move computing power from our servers to the edge of the cloud/network. We can do that once the algorithms are well-defined.

This allows us to compress data intelligently to improve connectivity. It makes pseudonymisation more effective and removes artefacts from the data that may disclose aspects of identity that we don’t fully understand. It minimises the data we collect and this, in turn, helps build patient trust.

Connected Computing

IoT thinking relies on a network of effective infrastructure which is not all within your direct control. Embracing interoperability and using technical standards allows us to simplify data integration from multiple sources (e.g. ePRO). This means that we reduce our dependence on using just one product or vendor and enhances human-centricity through data portability.

All Day, Everyday Data

Once we have extracted a sequence of events from sensor-level or on-board processed data, we can look at how these 24hr cycles start to build a picture of an individual. These include:

When we start to see the world of the patient in the data, measurement over multiple days gives us even further insight, including:

We can then begin to understand how our interventions have impacted them or how their disease has changed over time.

This comprehensive view will often reveal insights on patient populations that can be used in stratification or enrichment in further disease prevention or clinical trials.

For more information on how Activinsights can help with your next study, contact us on info@activinsights.com or call +44(0)1480 862082.

Activinsights Welcomes Two New Members of Staff

Activinsights is pleased to start off 2022 by welcoming two new members of staff; Matt Jones and Ian Page. The last year has seen huge growth for Activinsights with now ten new staff joining the company over the last 12 months as well as the move to a larger premises. This is a reflection of the ongoing success of the company and the addition of Matt and Ian will help us to take our offering even further into the clinical trials space.

 

Matt Jones
Quality Manager
With 15 years’ experience working in Pharmaceutical Quality Departments, Matt has branched out into medical devices to join Activinsights as our Quality Manager. Matt will be responsible for heading up all Quality aspects of the business, including maintaining and developing our Quality Management System. This will be important as we look to gain ISO13485:2016 accreditation for Medical Devices later in 2022.

 

Ian Page
Operations Manager
Ian is a specialist in manufacturing, engineering and production operations with senior management experience in major FMCG and blue-chip companies involving electronics, clean rooms and high-volume, high-precision manufacturing. With a BSc (Hons) in Production Technology and Production Management Engineering and an MSc in Manufacturing Systems Engineering with Chartered Engineer (CEng) accreditation, Ian will be responsible for leading the Activinsights Manufacturing and Logistics team and improving the customer journey.

We are pleased to have these new members of staff on board. If you would like to contact Ian or Matt, please call +44(0)1480 862082.

Webinar: Measuring Lifestyle Behaviours and Their Health Impacts with Wearable Technology

Our CTO and Founder, Joss Langford, recently hosted an informative webinar looking at why wearable devices are becoming more common in health and population surveillance. Joined by Melvyn Hillsdon from The University of Exeter, Joss discussed how wearable devices can be used to measure patient lifestyle remotely and provide detailed insights into behaviour, physical activity, and sleep patterns and the capabilities of wearable devices. The session also includes several case study examples.

If you missed this webinar, you can now catch up on YouTube.

Watch Now

 

About Activity Informatics

Activity Informatics is a collaboration between the University of Exeter and Activinsights.

The University of Exeter and Activinsights have built a specialist research capability in human physical activity and behaviour measurement that draws on the strengths of each partner.

Activity Informatics is a complete service for public-funded research and clinical trials that want to use wearable sensors. The service is designed for health and population surveillance researchers and service providers, who currently use or would like to use wearable devices for the measurement of lifestyle, activity and sleep. The offering includes all aspects of trial management including deploying/retrieving devices, managing data and processing digital health biomarkers.

Find out more about Activity Informatics.

Speakers:
Joss Langford – Chief Technology Officer & Founder, Activinsights
Melvyn Hillsdon – Associate Professor of Physical Activity and Population Health, University of Exeter