Health Apps for Managing Diabetes
Right now, you can find more than 300,000 health apps for your smartphone, tablet, and other mobile devices. That’s twice the number that was available just four years ago. Most of these apps provide general wellness information about things such as healthy food choices and physical activity, but a growing number promise to help people manage a specific condition. And more than 1 in 6 have been designed for people with diabetes.
Need to know how much insulin to take at mealtime? There are apps for that. Want help sticking with a treatment plan? There are apps for that, too. Many offer features that allow you to track details such as your blood glucose levels, the carbohydrates and calories you consume, the exercise you do, and more. All aim to ease the burden of living with diabetes. But how do you know they’re accurate? Who vets health apps and makes certain they function as advertised?
As it does with medications, the Food and Drug Administration (FDA) regulates medical devices to ensure that they are both safe and effective. Broadly speaking, such devices are defined as anything used to diagnose, treat, prevent, cure, or mitigate a disease. Medical devices range from simple instruments such as tongue depressors to complex health tools such as continuous glucose monitors (CGMs) and insulin pumps.
Also considered medical devices by the FDA: the health apps designed to help manage diabetes. Such apps must be cleared by the agency before they are made available to the public. Why? “Because [they] can impact the health of millions of Americans, [users] should be able to trust that these products do what they are supposed to do,” says Bakul Patel, associate director for digital health at the FDA’s Center for Devices and Radiological Health.
If you’re calculating your next insulin dose on the basis of an app’s recommendation, for instance, that information needs to be accurate. The FDA review process ensures that it will be. “Insulin is a potentially lethal medicine if you take too much,” says endocrinologist David Ahn, MD, a diabetes technology expert and program director at the Mary and Dick Allen Diabetes Center at Hoag Hospital in Newport Beach, California. All health app developers follow the same general procedures for FDA approval, he adds, but the clearance process is not one-size-fits-all. “Companies often engage the FDA early on in the development process to discuss with them what they need to do and what data they need to show in order to make approval happen,” Ahn says.
One such company is Welldoc, which first worked with the FDA on its app, BlueStar, about a decade ago, at the dawn of the smartphone era. At the time, the FDA was adapting its regulatory approach to include this new breed of device, and Welldoc’s chief strategy officer, Anand Iyer, PhD, MBA, says regulation for apps was uncharted territory for app developers at that time. Still, the company recognized that BlueStar, which helps users with aspects of diabetes management such as insulin dosing, fell under the agency’s traditional definition of a medical device, so it reached out to the FDA for guidance.
Welldoc worked with the FDA to determine what types of studies it needed to conduct in order to demonstrate BlueStar’s safety and effectiveness. That’s a typical part of the process. Developers test their own products and then share the results with the FDA to demonstrate that their software works properly and that any treatment recommendations made by the app provide benefits to users. For example, Welldoc showed that its app accurately calculates insulin-to-carb ratios based on the numbers that users enter and that it provides the right feedback when a user’s blood glucose is out of range. BlueStar received FDA clearance in 2010 and was released three years later, becoming the first health app to require a doctor’s prescription.
App developers must also evaluate what Patel calls “human factors” to determine if there’s any potential for misuse. “During FDA review, we assess the design of the mobile medical app and its user interface so that we can see whether any unreasonable risks are posed by the way users may interact with the device,” says Patel. For example, insulin dosing calculator apps must be designed so that users can’t mistakenly enter their glucose values in the wrong unit of measurement.
In addition to evaluating the app and any supporting studies, the FDA also inspects the developer’s work site and reviews its records, management practices, and quality control procedures, among other things, to make sure the company is following the agency’s required procedures during the development process.
The FDA focuses its oversight on health apps that perform significant functions that could put a user’s health at risk if the app doesn’t work properly. Such functions include the ability to:
- Activate a medical device, such as an app that could be used to control the delivery of insulin via an insulin pump. (No such app exists, but the FDA anticipates that one will be developed someday.)
- Turn your phone into a medical device via attachments or sensors. One example: an app that reads the results from a blood glucose meter that attaches to your phone, such as the one that’s used with the Dario Smart Glucose Meter system.
- Analyze data and provide treatment recommendations. Apps such as Glooko, which work in tandem with your blood glucose meter to determine your optimal insulin dose, fall into this category.
“The FDA regulates these types of apps very carefully,” says endocrinologist David Klonoff, MD, medical director of the Diabetes Research Institute at Mills-Peninsula Medical Center in San Mateo, California, and cochair of the annual Digital Diabetes Congress in San Francisco. “They are potentially dangerous if they don’t handle all the information properly.”
Low Risk? Free Pass
As for health apps the FDA considers low risk, the agency uses what it calls “enforcement discretion,” says Patel. That means it won’t actively regulate such apps, even if they fall under its own definition of a medical device. Such low-risk apps include those that:
- Offer lifestyle and behavioral coaching that promotes nutritious diets, regular exercise, and other health-focused strategies for people with conditions such as diabetes, heart disease, and high blood pressure. MyFitnessPal is an example.
- Enable users to log their health information—such as blood glucose readings, meals, and their mood—but don’t offer treatment recommendations based on that data. MySugr falls into this category.
- Allow users to communicate with their health care providers and access their electronic health records. One example is MyChart.
It’s up to the developer to decide whether or not its app falls into one of these low-risk categories, says Yarmela Pavlovic, a San Francisco–based lawyer who specializes in helping app developers and other medical device makers navigate the FDA’s regulatory process. The FDA encourages developers to seek the agency’s feedback. If the FDA determines the app doesn’t require regulation, however, it doesn’t get involved. “They’re not going to bother with it and they’re not going to grant clearance to it,” says Pavlovic. “It’s not worth their time or resources.”
Overall, Ahn applauds the agency’s hands-off approach, but not without caveats. Take, for instance, apps that offer dietary guidance. Ahn points out that there’s a lot of controversy in the medical and nutrition communities about what constitutes the best healthy-eating strategies. “Lifestyle recommendations are not without risk,” he says. For example, “a low-carb, high-fat diet might be very effective for an otherwise healthy person with type 2 diabetes, but that same diet might introduce risks in a patient with chronic kidney disease or known coronary artery disease.”
Ahn is much more positive about health apps that allow people to record details such as what they eat, their medication dose history, and their blood glucose readings. “I don’t have any reservations about what I call ‘life-logging’ apps,” he says. “They can motivate patients and keep them engaged.”
Looking to the Future
“The FDA has a good system that works right now, but we’re going to see an increasing number of apps developed,” says Klonoff, who predicts that the number of health apps could double over the next three years, slowing down the approval process. “Nevertheless, the FDA’s [approval process] for medical apps will allow consumers to have confidence that cleared regulated apps meet ever-evolving high standards for safety and effectiveness.”