The Smartinhaler technology platform consists of a group of sensor devices and software. The sensors are contained in a small plastic case that clips around an asthma inhaler to detect and record inhaler activation. Audiovisual alerts on the sensor device remind patients if any medication is missed, and data on inhaler use can be shared with clinicians via the software.
There are 3 device groups, SmartTurbo2, SmartTouch and SmartTouch AV. Each group accommodates different types of inhaler, and has slightly different functionality:
The SmartTurbo2 fits to the base of Turbohaler tubular inhalers.
The SmartTouch and SmartTouch AV clip around angled "press and breathe" type inhalers.
The SmartTouch AV has the additional feature of a small touch screen on the device itself. This allows reminders to be set and data to be reviewed directly on the device.
The Smartinhaler can also be used when a metered dose inhaler is combined with a spacer. Not all inhalers are compatible with the Smartinhaler.
Devices are available with non-rechargeable lithium coin cell batteries, or lithium polymer batteries that can be recharged using a USB connection. The expected service life for rechargeable devices is 2 years, and 1 year for non-rechargeable versions. For both types, low battery warnings are shown on the device.
All of the Smartinhaler devices record the date and time of inhaler activation. The devices do not record the quantity of medication inhaled by the patient, or how much medication is left in the canister. It also cannot record whether a good inhalation technique was used.
The software packages in the Smartinhaler technology platform are:
SmartinhalerLive, a cloud-based application that stores the uploaded data on inhaler activation. It is available for a monthly fee, and allows data to be shared by the inhaler user to their family and clinical teams, according to the permissions set. Data is uploaded using the Smartinhaler app or the Smartinhaler Connection Centre.
Smartinhaler app, which is available for iPad, iPhone and Android smartphones and tablets. This allows the user to set the reminders on their device and to review their own data for the last 7 or 28 days. It also uploads the data from the device to the SmartinhalerLive website via a USB or Bluetooth connection.
Smartinhaler Connection Centre, a desktop application that is used to upload data from the device to the SmartinhalerLive website via a USB connection on a computer.
The innovative feature is the sensor to detect inhaler activation, and the communication of this information to the Smartinhaler app and SmartinhalerLive software. The technology sends reminders of missed medication doses to the patient, and potentially allows adherence to medication to be tracked and shared with clinical teams. This may help the patient to adhere to their medication schedule, and aid the clinical team in understanding patient adherence.
NICE's quality standard on asthma states that people who are diagnosed with asthma should have a personalised action plan, and this should be reviewed at least once per year. The review should include medication, inhalation techniques and adherence (Royal College of Physicians 2015, Asthma UK 2016).
People with asthma may be treated in primary or secondary care. Medication is generally prescribed in the form of preventer (corticosteroid) and reliever (bronchodilator) inhalers, although not all patients will need both of these. Some people have these combined into a single inhaler, known as maintenance and reliever therapy.
Preventer inhalers are taken regularly, even when feeling well. Non-adherence to preventer medication is associated with increased risk of poor asthma control.
Reliever inhalers are taken only when needed. Overuse of short-acting bronchodilators is a key indicator of poor asthma control and of higher risk of exacerbation and death (Royal College of Physicians, 2015). People experiencing a severe asthma attack may need emergency medical care; 185 people are admitted to hospital and 3 people die from an asthma attack in the UK each day, often before emergency medical care can be given (NHS Choices, Asthma UK).
It can be difficult for patients to accurately estimate the medication taken, and adherence is likely to be over-reported to clinicians (Morton 2014, BTS/SIGN 2016). Accurate information on adherence may help to identify if it is a factor in asthma control. Current guidance (BTS/SIGN 2016) mentions the use of prescription records and self-reporting to assess adherence. The use of electronic monitoring systems is described as a gold standard for research, but not normally available for clinical use.
NICE is aware of the following CE-marked devices that appear to fulfil a similar function as Smartinhaler:
HeroTracker, Cohero Health
CareTRx, Teva Pharmaceuticals
Propeller System, Propeller Health
Smartinhalers are intended to be used by people with asthma in any setting including at home and in the community, as part of their normal routine. They may be used to monitor medication use for respiratory diseases including asthma. Smartinhalers can be used by adults and children.
Smartinhaler devices are available for preventer, reliever and maintenance and reliever therapy inhalers. Some training will be needed to familiarise patients and clinicians with the device and associated software. This may include fitting the device correctly and checking inhaler technique. Patients will need to be advised of what data is captured and how they are able to view it.
Smartinhaler does not monitor the inhalation technique when it is activated. Therefore patient education is important to ensure that the correct inhalation technique is used.
The Smartinhaler device attaches to a compatible inhaler. The 3 different types of Smartinhaler (SmartTouch, SmartTouch AV and SmartTurbo2) each cost £100. Prices may vary for high-volume purchasers. The cost of the inhaler is not included.
To collect and interpret the data from the Smartinhaler device, the cloud-based SmartinhalerLive software is needed. Access to this service costs £14.17 per month for each healthcare professional logging into the system. The manufacturer has stated that this cost would be subject to negotiation depending on the volume uptake. There is no additional cost to the patient to access their data via an app on a smartphone or tablet.
The device can be removed and attached to a new inhaler when the inhaler needs replacing. Non-rechargeable devices will operate for at least 1 year and rechargeable devices have an expected service life of 2 years.
The manufacturer advises that the Smartinhaler is currently in use in the NHS both as part of the patient pathway and as a measurement tool in clinical trials.
Use of Smartinhaler could potentially lead to a change in the approach to reviewing personal action plans for asthma, with data used to identify people who need more frequent review, or who do not need to be seen in person for an annual review.
Currently, the use of Smartinhaler devices and software would be an additional cost to standard care. It could serve to improve interactions between people with asthma and their clinicians, and improve adherence to asthma therapy. This in turn could improve asthma symptoms, meaning fewer days missed from school, work or normal activities, and reduce the need for additional interventions or emergency admissions. The evidence for these possible resource consequences is limited at the present time.
Although the data recorded by Smartinhaler can be uploaded using a computer, in order to use the full functionality of some Smartinhaler devices, the user would need a smartphone. Clinicians will need to have enough time to review the data collected and give feedback on adherence.