Summer is upon us, and for millions of kids, that means vacation and overnight camp season. But while many daydream about fun in the sun, for patients with pediatric Type 1 diabetes, being away from home—and the people who manage their treatment most closely—can prove to be problematic.
This is just one example of the important role medical apps can play in helping patients (and, in this case, camp counselors) manage their care in day-to-day life—away from the doctor’s office or clinic setting. The popularity of these apps speaks to the need for this kind of support. But simply making apps available isn’t enough. How can providers ensure patients are using them properly, safely, and to their full potential?
Early insights into patient needs
Back in 2003, a juvenile diabetes association set out to solve the “summer camp dilemma” described above. The group organized a summer camp for pre-teens with Type 1 diabetes. They knew that if the children didn’t closely follow their treatments or properly calculate their insulin doses, they could suffer from hypoglycemic episodes that would send them straight to the ER and abruptly put an end to a well-meaning trip.
The solution to the association’s problem was an early “app-like” technology: A web portal on which patients could log their blood glucose measurements and insulin data, carbohydrate intake and daily activity levels, and transmit the information to their treating practitioners. The care team could then review the data daily and call the camp to make treatment adjustments if necessary. It was one of the first examples of remote care through the web and it worked perfectly—for two weeks. But once the kids went home, they stopped using the technology. What happened? The vision for this technology was for its continued use beyond the camp—with patients and practitioners continuing to communicate remotely to change their daily lives. It was a daily reporting system that could help prevent hypoglycemic events and improve patient-practitioner coordination. Why didn’t the patients want to use it?
Bringing “patient centricity” to medical apps
When asked, the patients said consistently that spending time to log data made them feel as if they were working for their doctors, not for themselves. They weren’t getting anything directly out of the reporting.
The association’s portal experiment delivered one paramount fundamental: Alongside the need to remotely monitor patients (and the health benefits associated with it), patients needed to feel motivated to engage with the technology each day. Physicians’ capacity to remotely and conveniently monitor their patients increased but, ultimately, patients needed motivation to consistently log their data in order for it to work.
How could patients be so motivated? For insulin-treated patients who must calculate their insulin doses multiple times a day, the most useful decision support would come in the form of recommending insulin doses according to their treatment plan. “Companion software” could deliver this real-time decision support. Like “companion diagnostics,” the term companion software is meant to convey that it is a companion to patients and their treatment. Made up of a mobile patient app and connected physician web portal, companion software would accompany and enhance medical treatment by empowering patients to make decisions in real-time. Now, the portal wasn’t just designed for physicians to receive information; it provided an immediate and systematic benefit to patients when they shared information.
Companion software now and in the future
The concept of companion software has blossomed with the explosion of medical apps during the past decade. Over the past ten years, remote monitoring and personalized medicine have revolutionized the medical industry. In 2015, the number of remotely monitored patients increased by 51%, jumping to 4.9 million, according to a Berg Insight report cited in a December eWeek article. This number is expected to reach an estimated 36.1 million remotely monitored patients by 2020. But remotely followed patients still need to be motivated to use these solutions.
To really sustain patient engagement, companion software must be reassuring, incentivizing, relevant, empowering, and collaborative. The healthcare practitioner should prescribe the app, which carries the weight of an official physician recommendation and initiates the patient’s motivation. Then, the healthcare practitioner should personalize the app according to the patient’s treatment plan, specific situation, and objectives. That way, patients feel they have a reliable solution for their particular situation that conveys their physician’s guidance in conjunction with their needs.
If patients are required to regularly take the time to enter data, then they need to be provided with incentives, such as a real-time feedback loop. This loop should deliver incremental value on top of the treatment by transforming data into medical intelligence. With this intelligence, it can empower patients to take a more active role in their disease management by providing active decision-making support. Finally, the app can automatically share this information with the practitioner to ensure a two-way dialogue that allows the practitioner to remotely monitor the patient and fuel further collaboration, supported by common metrics, terms, analysis, etc.
All of this requires digitizing sophisticated, protocol-based clinical algorithms that can deliver real-time recommendations to patients in an app that remains simple and easy to use. These algorithms take the medical app beyond mobile software to a regulated medical device. Because they support active treatment decisions, their development must be fully compliant with all regulations to ensure their safety. Because they intend to support disease management, their potential claims must be supported by clinical evidence and validated by regulatory bodies. This engenders the need to go through regulatory clearance, to ensure their safety and prove efficacy, in the same way a medication or medical device needs to.
With the rise of out-of-hospital care, there is a growing need for medical apps that have been cleared by regulatory bodies in a sea of unregulated technology. In the case of diabetes, a 2015 study by Huckvale, et al., published in BMC Medicine, found that 67% of insulin calculator apps carried a risk of inappropriate output dose recommendations that violated basic clinical assumptions. Beginning in 2011, the U.S. Federal Trade Commission has routinely removed fraudulent medical apps from app stores. In fact, there are over 55,000 medical apps on the market, and only approximately 150 have been able to achieve FDA clearance.
Beyond regulatory clearance, companion software should go through clinical trials to demonstrate its efficacy as well as potential economic gains for payers. As practitioners are pivotal in driving remote monitoring and prescribing the app to patients, it’s crucial to deliver clinical evidence. Yet even fewer available apps, approximately 30, have been proven effective and safe through clinical trials.
The bottom line
As medical technology expands, companion software has an essential role to play in helping drugs achieve their optimal clinical outcomes in the real world. It has the ability to help patients self-manage side effects, self-monitor their symptoms, and self-dose treatment and connect patients with their healthcare team. Beyond diabetes, companion software can be adapted to help patients manage many chronic diseases that severely impair quality of life, from multiple sclerosis to psoriasis and from hemophilia to oncology. We are in the throes of a digital medical revolution but we must be careful to also inscribe these products in the clinical trial processes and regulations that have historically proven to keep patients safe.