Smartinhaler, a "smart" personal medication monitoring system from Adherium Ltd., has shown effectiveness in reducing hospital admissions over a 12-month independent, randomized controlled trial involving children with poorly controlled asthma. The study was conducted at Sheffield Children's Hospital in the UK, and the results were published online in the peer-reviewed medical journal Thorax.
The Smartinhaler system consists of connected sensor devices that fit discretely onto medication inhalers; apps that connect to the device and monitor medication adherence, usage, dosage, and provide patient reminders; and software for analysis of patient and medication usage data by caregivers, reported Garth Sutherland, CEO of New Zealand-based Adherium.
"The Bluetooth-enabled Smartinhaler medication sensors wrap around patients' existing inhalers and automatically send usage data to their smartphone," Sutherland explained. "The Smartinhaler app enables the patient and health care professionals to track medication adherence, set daily reminders, and discover insights into their medication usage. The Smartinhaler app enables real-time reporting, monitoring, data storage and analysis of inhaler use."
The app can work with one or more Smartinhaler devices on multiple inhalers, and it provides a view of medication usage patterns as well as the ability to set audio visual reminders on the Smartinhaler device itself to help ensure no doses are missed, he added.
Smartinhaler performs the following functions: it records the time and date of inhaler use, independent of patient action; it transmits patient usage data to a mobile device and into the Adherium cloud-based servers; and it alerts and reminds patient about the medication. "The dedicated health professional, with patient consent, can also access the data to review patient progress," Sutherland said.
To monitor dosing behavior from month to month and identify any trends that could signal a poor outcome, patients (via their smartphone app) and their physicians (via the portal) can see drug usage on a simple dashboard, he added.
After use, Smartinhaler can be removed from the empty inhaler and then attached to the new one. Smartinhaler does not mechanically impact drug delivery or dose counters from the existing inhaler in any way, Sutherland added.
Smartinhaler is drug/brand agnostic, says Sutherland. "Adherium tailors different Smartinhaler devices for each partner pharmaceutical company's proprietary dry powder or pressurized metered dose inhaler," he said. "This allows pharmaceutical companies to supply the Smartinhaler devices directly to patients and be confident that they can only be used with that company's product."
Adherium has become the exclusive smart inhaler partner for AstraZeneca with 10-year global supply and development agreement.
Adherium believes Smartinhaler can address the problem of medication nonadherence in chronic respiratory conditions. "An estimated 300 million people worldwide suffer from asthma, with 250,000 annual deaths attributed to the disease, and almost all of these deaths are avoidable. The U.S. Centers for Disease Control estimate there are 25.5 million asthmatics and 6.8 million people with COPD in the US," Sutherland said.
The Sheffield study "showed unequivocal independent evidence that digital monitoring impacts clinical outcomes, not just medication adherence, in children with poorly controlled asthma," Sutherland said, pointing to these achievements:
- Five-fold reduction in hospitalizations observed in patients using Smartinhaler.
- Smartinhaler use resulted in sustained increase in medication adherence and significant reduction in asthma exacerbations.
- Days off school and doctor visits reduced.
- Clinical benefits increased over time, particularly at nine and 12 months.
"These benefits, particularly the reduced number of hospitalizations, make a clear, cost-saving argument for introducing Smartinhaler into standard practice, which can easily be done without disruption to the patient's medication, routine, or care plan. With this data, Adherium can now offer healthcare providers, payers and insurers a cost-effective way of improving chronic respiratory care," he said.
Adherium has FDA 510(k) clearance to market Smartinhaler in the United States as well as CE Marks for its devices and software in major markets, including EU, Canada, Australia, New Zealand,and China."The Smartinhaler platform has been used in over 30 countries, in more than 65 projects (clinical, device validation or other) and has peer reviewed journal articles resulting from 14 studies," Sutherland said.