The study comes as FDA is moving to bring more order to the area of mobile health. It is in the midst of a pilot for a precertifcation process that involves well-known companies such as Apple, Verily, and diabetes-specific companies like Tidepool.
Only a tiny fraction of the commercially available diabetes apps lower glycated hemoglobin (A1C), and most are never fully studied, revealing how payers must be careful when deciding whether to cover new technologies to help patients manage their condition.
The Agency for Healthcare Research and Quality (AHRQ), a federal entity, reported earlier this month that diabetes apps account for 16% of the more than 318,000 mobile health apps on the market. Yet agency researchers who combed scientific databases could find studies for only 11 of them, and just 5 were shown to lower A1C.
Researchers found 15 studies for the 11 apps—6 apps for type 1 diabetes (T1D), and 5 apps for type 2 diabetes (T2D).
Patients using 2 of the T1D apps were able to see fewer incidents of hypoglycemia, but they did not see improvements in quality of life, blood pressure, weight, or body mass index.
“Although consumers have access to dozens of apps for diabetes management, only a handful of these technologies have been evaluated,” AHRQ Director Gopal Khanna, MBA, said in a statement released with the report. “AHRQ’s report helps identify an important area where more research will help us understand how these apps can improve the health of people with diabetes.”
Of the 8 apps available for usability testing, 2 designed for T1D patients and 1 for T2D patients were scored “acceptable,” while 2 other T1D apps were deemed “marginal,” and 3 more were labeled “unacceptable,” including 1 for T1D and 2 for T2D. In their report, AHRQ researchers found that people with diabetes may have some difficulty using the apps, and there may be some questions about who sees the data and how it will be used.
Some diabetes apps that purport to be “free” collect patient data that are then sold to third parties for commercial or research purposes. A series of mergers in the diabetes technology space has raised questions about the ultimate use of some patient data.
FDA has shown interest in bringing order to the world of digital health innovation, while making clear which apps it seeks to regulate and which it does not. Commissioner Scott Gottlieb, MD, has taken an approach that says software developers should not need agency approval on each iteration of improvement; rather, developers could collect data and present it to regulators to show that the product is performing as expected.
The agency is now piloting a pre-certification process that drew 9 participants, including Apple, Verily, Tidepool, Fitbit, Roche, and Johnson & Johnson.
Previously, WellDoc’s BlueStar app for T2D was the only product of its kind to have both prescription and non-prescription versions of its diabetes management platform with FDA clearance. The non-prescription version was developed for easier integration into health plans, according to a company statement at the time of clearance.
While BlueStar has been well-studied, this is not typical. Khanna said the AHRQ report serves as a call to action for more work on apps within the research community.
Veazie S, Winchell K, Gilbert J, et al. Mobile applications for self-management of diabetes. Technical brief 31. AHRQ Publication No. 18-EHC010-EF. Rockville, MD: Agency for Healthcare Research and Quality; May 2018. doi: http://doi.org.10.23970.AHRQEPCTB31.