IoT medical devices

IoT medical devices
The Internet of Things (IoT) has opened up a world of possibilities in medicine: when connected to the internet, ordinary medical devices can collect invaluable additional data, give extra insight into symptoms and trends, enable remote care, and generally give patients more control over their lives and treatment.

1. Cancer treatment

In June 2018, data was presented at the ASCO Annual Meeting from a randomised clinical trial of 357 patients receiving treatment for head and neck cancer. The trial used a Bluetooth-enabled weight scale and blood pressure cuff, together with a symptom-tracking app, to send updates to patients’ physicians on symptoms and responses to treatment every weekday.

The patients who used this smart monitoring system, known as CYCORE, experienced less severe symptoms related to both the cancer and its treatment when compared to a control group of patients who carried on with regular weekly physician visits (with no additional monitoring). Bruce E. Johnson, President of ASCO (the American Society of Clinical Oncology), said that the smart technology “helped simplify care for both patients and their care providers by enabling emerging side effects to be identified and addressed quickly and efficiently to ease the burden of treatment.”

The study demonstrates the potential benefits of smart technology when it comes to improving patient contact with physicians, and monitoring of patients’ conditions, in a way that causes minimal interference with their daily lives. As Richard Cooper, Head of Digital at AXA PPP Healthcare, told Econsultancy in an interview about the future of health tech,

“Some of the developments we see have stopped people being tied to their house, or kept them from being regularly in hospital.

“They’re solving what are in some cases quite simple problems, and giving people that quality of life back. … Technology makes your interaction with your medical professional much more powerful and useful, and puts you more in control.”

2. Smart continuous glucose monitoring (CGM) and insulin pens

Diabetes has proven to be a fertile ground for the development of smart devices, as a condition that affects roughly one in ten adults, and one that requires continual monitoring and administration of treatment.

A Continuous Glucose Monitor (CGM) is a device that helps diabetics to continuously monitor their blood glucose levels for several days at a time, by taking readings at regular intervals. The first CGM system was approved by the US Food and Drug Administration (FDA) in 1999, and in recent years, a number of smart CGMs have hit the market.

Smart CGMs like Eversense and Freestyle Libre send data on blood glucose levels to an app on iPhone, Android or Apple Watch, allowing the wearer to easily check their information and detect trends. The FreeStyle LibreLink app also allows for remote monitoring by caregivers, which could include the parents of diabetic children or the relatives of elderly patients.

These devices are even starting to become available on the NHS: on World Diabetes Day 2018 (14th November), the NHS announced that it would be making the FreeStyle Libre smart CGM available on prescription to Type 1 Diabetes sufferers. It estimated that this would increase the percentage of diabetes patients who have access to smart CGM devices in England from 3-5% to 20-25%. Another smart device currently improving the lives of diabetes patients is the smart insulin pen. Smart insulin pens – or pen caps – like Gocap, InPen and Esysta have the ability to automatically record the time, amount and type of insulin injected in a dose, and recommend the correct type of insulin injection at the right time.

The devices interact with a smartphone app that can store long-term data, help diabetes patients calculate their insulin dose, and even (in the case of the Gocap) allow patients to record their meals and blood sugar levels, to see how their food and insulin intake are affecting their blood sugar.

3. Closed-loop (automated) insulin delivery

One of the most fascinating areas in IoT medicine is the open-source initiative OpenAPS, which stands for Open Artificial Pancreas System. OpenAPS is a type of closed-loop insulin delivery system, which differs from a CGM in that as well as gauging the amount of glucose in a patient’s bloodstream, it also delivers insulin – thus “closing the loop”.

OpenAPS was started in 2015 by Dana Lewis and her husband Scott Leibrand, who hacked Dana’s CGM and her insulin pump in order to automate the delivery of insulin into her system. Using the data feed from the CGM and a Raspberry Pi computer, their own software completes the loop and continuously alters the amount of insulin Dana’s pump delivers.

Automating insulin delivery offers a number of benefits that can change the lives of diabetics. By monitoring an individual’s blood glucose levels and automatically adjusting the amount of insulin delivered into their system, the APS helps to keep blood glucose within a safe range, preventing extreme highs and lows (otherwise known as hyperglycaemia – excessively high glucose – and hypoglycaemia – excessively low glucose).

The automatic delivery of insulin also allows diabetics to sleep through the night without the danger of their blood sugar dropping (also known as night-time hypoglycaemia).

Although OpenAPS is not an “out of the box” solution and requires people to be willing to build their own system, it is attracting a growing community of diabetics who are using its free and open-source technology to hack their insulin delivery. The OpenAPS website declares that, “As of January 15, 2018, there are more than (n=1)*1,078+ individuals around the world with various types of DIY closed loop implementations.”

The OpenAPS community aren’t the only ones to have had this idea. In 2013, Bryan Mazlish, a father with a wife and young son who both have Type 1 Diabetes, created the first automated and cloud-connected closed-loop artificial pancreas device. In 2014, he founded SmartLoop Labs – now known as Bigfoot Biomedical – to scale and commercialise the development of an automated insulin delivery system based on his invention.

The company is currently preparing for a pivotal trial of its solution, details of which are due to be announced in “late 2018 or early 2019”. Bigfoot currently anticipates that its automated system will be launched commercially in 2020, pending FDA review and approval.

4. Connected inhalers

Like diabetes, asthma is a condition that impacts the lives of hundreds of millions of people across the world. Smart technology is beginning to give them increased insight into and control over their symptoms and treatment, thanks to connected inhalers.

The biggest producer of smart inhaler technology is Propeller Health. Rather than producing entire inhalers, Propeller has created a sensor that attaches to an inhaler or bluetooth spirometer. It connects up to an app and helps people with asthma and COPD (Chronic Obstructive Pulmonary Disease, which includes emphysema and chronic bronchitis) understand what might be causing their symptoms, track uses of rescue medication, and also provides allergen forecasts.

The company was founded in 2010, and in 2014 received FDA clearance for two sensors designed to work with inhalers from major pharma companies: GlaxoSmithKline’s Diskus inhaler, and the Respimat inhaler from Boehringer Ingelheim. Since then, Propeller has continued to collaborate with a number of major producers of inhalers, and now says that its sensor “works with most inhalers and leading bluetooth spirometers”.

One of the benefits of using a connected inhaler is improved adherence – in other words, medication is taken more consistently and more often. The Propeller sensor generates reports on inhaler use that can be shared with a patient’s doctor, and show whether they are using it as often as is prescribed. For patients, this provides motivation and also clarity, showing how the use of their inhaler is directly improving their condition.

5. Ingestible sensors

Proteus Digital Health and its ingestible sensors are another example of how smart medicine can monitor adherence. According to a study by the World Health Organisation in 2003, 50% of medicines are not taken as directed.

Proteus’ system is one effort to reduce this figure: the company has created pills that dissolve in the stomach and produce a small signal that is picked up by a sensor worn on the body. The data is then relayed to a smartphone app, confirming that the patient has taken their medication as directed.

Proteus has so far trialled the system with pills for treating uncontrolled hypertension and Type 2 Diabetes, and antipsychotic medication. In late 2017, ABILIFY MYCITE – an antipsychotic medication created by Proteus and Otsuka Pharmaceutical Co. – became the first FDA-approved drug with a digital tracking system.

As with connected inhalers, ingestible sensors can help to track and improve how regularly patients take their medication, as well as allowing them to have a more informed dialogue with their physician about treatment. While the idea of taking pills with a sensor might seem invasive, the system is opt-in on the part of patients, and they can discontinue sharing some types of information, or opt out of the program altogether, at any time.

6. Connected contact lenses

Medical smart contact lenses are an ambitious application of the Internet of Things in a healthcare context. While the concept has a great deal of potential, so far, the science hasn’t always managed to live up to expectations.

In 2014, Google Life Sciences (now known as Verily, a subsidiary of Google’s parent company Alphabet) announced it would be developing a smart contact lens that could measure tear glucose and provide an early warning system for diabetics to alert them when their blood glucose levels had dropped or risen beyond a certain threshold. It partnered with Alcon, the eyecare division of pharmaceutical company Novartis, for the project.

However, the project attracted a great deal of scepticism from researchers who believed that the idea of measuring blood glucose levels via tears wasn’t scientifically sound – and ultimately, they were proven correct. After a lengthy period with no real news about project developments, in November 2018 Verily confirmed that the project was being shelved.

But other medical applications for smart contact lenses might prove more successful. Verily is still working on two smart lens programs with Alcon, which aim to treat presbyopia (long-sightedness caused by a loss of elasticity in the lens of an eye) and cataract surgery recovery.

Swiss company Sensimed has also developed a noninvasive smart contact lens called Triggerfish, which automatically records changes in eye dimensions that can lead to glaucoma. First developed in 2010, Triggerfish is now CE-marked and FDA-approved, meaning it is approved for marketing and sale in Europe and the U.S., and was approved for sale in Japan in September 2018.

7. The Apple Watch app that monitors depression

Wearable technology doesn’t always have to be designed with a medical use in mind to have healthcare benefits. Takeda Pharmaceuticals U.S.A. and Cognition Kit Limited, a platform for measuring cognitive health, collaborated in 2017 to explore the use of an Apple Watch app for monitoring and assessing patients with Major Depressive Disorder (MDD).

The results from the exploratory study were presented in November 2017 at pharma and biotech conference CNS Summit.

The study found a very high level of compliance with the app, which participants used daily to monitor their mood and cognition. The app’s daily assessments were also found to correspond with more in-depth and objective cognition tests and patient-reported outcomes, showing that cognitive tests delivered via an app can still be robust and reliable.

While the study was only an exploratory pilot, it has demonstrated the potential for wearable tech to be used to assess the effects of depression in real-time. Like other smart medical devices that gather data, the Apple Watch app could also give patients and healthcare professionals more insight into their condition, and enable more informed conversations about care.

8. Coagulation testing

In 2016, Roche launched a Bluetooth-enabled coagulation system that allows patients to check how quickly their blood clots.

This is the first device of its kind for anticoagulated patients, with self-testing shown to help patients stay within their therapeutic range and lower the risk of stroke or bleeding.

Being able to transmit results to healthcare providers means fewer visits to the clinic. The device also allows patients to add comments to their results, reminds them to test, and flags the results in relation to the target range.

9. Apple’s ResearchKit and Parkinson’s Disease

In 2018, Apple added a new ‘Movement Disorder API’ to its open-source Research Kit API, which allows Apple Watches to monitor Parkinson’s Disease symptoms.

Normally symptoms are monitored by a physician at a clinic via physical diagnostic tests, and patients are encouraged to keep a diary in order to give a broader insight into symptoms over time. The API aims to make that process automatic and continuous.

An app on a connected iPhone can present the data in a graph, giving daily and hourly breakdowns, as well as minute-by-minute symptom fluctuation.

Apple’s ResearchKit has also been used in a number of different health studies, including an arthritis study carried out in partnership with GSK, and an epilepsy study that used sensors in the Apple Watch to detect the onset and duration of seizures.

Apple is keen to tout the potential for its apps to aid with medical research and care, and to that end, in 2017 it launched CareKit, an open-source framework designed to help developers to create apps for managing medical conditions. Unlike HealthKit, which is aimed more at general fitness and wellbeing, CareKit can be used to design apps with a specific medical purpose – so watch this space for more medical innovations that make use of iPhone and Apple Watch technology.

10. ADAMM Asthma Monitor

ADAMM is a wearable smart asthma monitor that purports to detect the symptoms of an asthma attack before its onset, allowing the wearer to manage it before the attack gets worse.

It vibrates to notify the person wearing it of an impending asthma attack, and can also send a text message to a designated carer at the same time. Other features of the device include inhaler detection – the device can detect and track inhaler use, if the patient can’t remember whether they’ve used one – and voice journaling to record things like changes, feelings and behaviours.

It also has an algorithm technology that learns what ‘normal’ is for the wearer over time, allowing it to better understand when something has changed.

ADAMM works in conjunction with an app and web portal, helping asthma patients to set medication reminders, view data from the device, and remind themselves of their treatment plan.

The device was originally expected to achieve FDA clearance and be released for consumers at the end of 2017, but hasn’t yet been cleared, showing that these devices can sometimes take a long time to come to market even once developed. However, a study on patient health monitoring platforms that incorporate IoT devices published in July 2018 mentions that ADAMM is “expected to receive FDA clearance soon”. Summary

There are obvious concerns of vulnerability involved with connected healthcare, which along with the rigour of drug development may be slowing the development of new digital medicines. However, it’s clear which way the wind is blowing. From adherence to diagnosis, the applications are manifold.

In particular, life logging (which granted is often a case of mobile health, not strictly IoT) seems still to be a powerful idea, changing how patients interact with their clinic. This is particularly the case for measuring subjective data for those suffering from anxiety or depression.

Ultimately, one can see why Apple is getting into this space with HealthKit, ResearchKit and CareKit, and Google with GoogleFit and subsidiaries like Verily. It’s not hard to imagine a future in which iOS or Android apps interact with much of our medicine.

As more of these devices are brought to market and even become available as prescription medication, for example on the NHS, digital healthcare will start to become the rule rather than the exception.

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