What do pharmacists need to know about these mobile applications recently approved by the FDA?
Mobile applications for health is a maturing market that has been gaining traction for clinical utilization in patient care. Although apps developed years ago focused on allowing patients to track their medical status and get health information, there was a significant lack of oversight on actual patient-focused outcomes, due in part to a lack of clinical data or approval.
One area where significant inroads have been made is in apps aimed at helping patients dose insulin. The FDA has granted approval to several companies in 2017, including Eli Lilly's Go Dose,1 Sanofi's My Dose Coach,2 and Voluntis' Insulia.3 Previously, Roche had one of the only apps, which was approved in 2015, built into its Accu-Chek Connect app. Other apps exist but are only available in Europe, because of issues getting clearance in the United States. These are important developments, especially considering that the results of a study from 2015 published in BMC Medicine found that of 46-insulin dosing calculators available at the time on the iOS and Android App store, almost none had clinical standards up to par to perform their function, and some even provided incorrect doses.4
These apps vary in approval for what insulin they can be used with, and that will probably allow them to be competitive. For patients using these apps, providers will have to help them set them up, but the value proposition is that it is a virtual treatment plan for providers to help monitor and manage their patients' insulin therapy remotely without needing to schedule in-clinic visits.
This is a quite fascinating development, as the issue in the past has been educating patients on appropriately using insulin to treat diabetes, while minimizing the risk of hypoglycemia secondary to too much insulin. The results of a recent study published in JAMA sought to identify whether insulin pumps or injection therapy was safer in patients with type 1 diabetes mellitus (DM) and found that pumps had fewer events of hypoglycemia and ketoacidosis. Those patients tested more often and perhaps had access to better tools to help guide their therapy, which could explain the difference. Smart insulin pens are also being developed to help dose insulin. It can be argued that we are seeing a revolution in insulin dosing technology, which is amazing for a drug that has been around for almost a century.5
For pharmacists, the takeaways will be that we may soon see new devices coming into our pharmacies for patients to use for DM management, and we may be asked questions related to the available tools or devices that they can use. At this time, some recommendations can be made, and we may be responsible dispensing such devices shortly.
1. Comstock J. Eli Lilly gets FDA clearance for insulin dose calculator app. MobiHealthNews. mobihealthnews.com/content/eli-lilly-gets-fda-clearance-insulin-dose-calculator-app. Published January 19, 2017. Accessed November 20, 2017.
2. Comstock J. Sanofi gets FDA clearance for insulin dose calculator app. MobiHealthNews. mobihealthnews.com/content/sanofi-gets-fda-clearance-insulin-dose-calculator-app. Published April 6, 2017. Accessed November 20, 2017.
3. Insulia receives FDA clearance and CE mark to integrate Basaglar and Tresiba [news release]. Cambridge, MA: November 16, 2017. voluntis.com/en/news/news-1/2017/basaglar-tresiba-clearance?platform=hootsuit. Accessed November 20, 2017.
4. Huckvale K, Adomaviciute S, Prieto JT, Leow MK, Car J. Smartphone apps for calculating insulin dose: a systematic assessment. BMC Med. 2015;13:106
5. Hoskins M. New smart insulin pens marking it to market. Healthline. healthline.com/diabetesmine/next-generation-smart-insulin-pens#2. Published August 17, 2016. Accessed November 20, 2017.