Quantity of diabetes apps makes it tough to determine quality

The large and ever-growing number of mobile apps designed for people with diabetes makes determining the best choices difficult, but a Friday session will help educators sort through all of the choices to help their patients find the best fits.

“FDA Guidance and an Educator’s Perspective on the Avalanche of Apps” will focus on how educators can properly evaluate apps for both safety and effectiveness. The session also will explain the FDA’s role as more and more apps become available every month.


Molly McElwee-Malloy, RN, CDE

Molly McElwee-Malloy, RN, CDE, Head of Patient Engagement for TypeZero Technologies, said that as of this summer 84 apps available on Google Play and the Apple Store offered guidelines for insulin dosing. Only two have FDA approval.

“My biggest problem with that is unless you’re going to the website, reading the terms and conditions and all the fine print, you don’t know the origin of the app on first sight, and you don’t know the testing,” she said. “I’m going to walk people through how to investigate that.”

McElwee-Malloy will give guidelines for educators about how to evaluate these apps and how to investigate apps that patients bring to the educators.

Many wellness apps—which do not require regulation—do a reliable job of helping patients track carbohydrates, calories and other food information along with fitness data.

Educators need to know what apps their patients are using and how they work so they can confidently make recommendations. McElwee-Malloy said that educators needed to have a good list of apps that they trust for their patients. That only comes from researching, downloading and testing the apps.

“There’s nothing worse to me than when I’m interacting with another clinician—because I have type 1 diabetes—and asking for a recommendation and I hear, ‘I really don’t understand that area.’ We really need to be knowledgeable on this,” she said.


Courtney Lias, PhD

Courtney Lias, PhD, a Division Director in the Center for Devices and Radiological Health at the FDA, will provide attendees with a general understanding of the FDA policies regarding apps along with some specifics about dosing apps and how the FDA can help improve the safety of apps for the public.

In 2015, the FDA published a guidance document about mobile medical applications. The goal was to provide some clarity about the different types of apps that might fall under FDA review vs. apps that didn’t fall under review.

The FDA also had a public meeting on insulin dosing apps and dosing calculators, which are included in many dosing apps. Dr. Lias said the feedback from diabetes educators was mixed. While the educators are for any tool that will help them help their patients, they had concerns about certain apps patients might bring them.

“We heard a lot from diabetes educators about the challenges that they face in working with patients who want to use these apps, choosing the apps, the good and bad apps that they’ve seen out there and why they were good and bad,” she said. “So I plan to cover that from the FDA’s perspective.”

The FDA started working with apps in the diabetes field about eight years ago, Dr. Lias said. Biotech firms saw a great opportunity and an eager public.

“As soon as mobile phones started to have apps widely available and people started to use smartphones, manufacturers started to develop apps,” she said. “And with diabetes being such a consumer-oriented area, we got them on the front end.”

Friday Session
FDA Guidance and an Educator’s Perspective on the Avalanche of Apps
2:00 pm – 3:00 pm | Room 6DE

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