Clinical Edge

Summaries of Must-Read Clinical Literature, Guidelines, and FDA Actions

FDA Approves Insulia Diabetes Management App

Voluntis news release; 2017 Jul 18

Insulia, a digital management application for people with type 2 diabetes (T2D), has received FDA clearance and the CE mark to integrate with Toujeo (insulin glargine U-300). Insulia had previously received FDA clearance and the CE mark for insulins Lantus and Levemir in 2016.

Insulia is a prescription-only digital companion for people with T2D that combines a patient mobile app and health care practitioner (HCP) web portals. The mobile app provides real-time basal insulin dosing recommendations and educational coaching messages based on blood glucose values. The HCP web portal allows HCPs to configure personalized treatment plans and prescribe the app, then follow their entire patient population remotely.


Insulia receives FDA clearance and CE mark to integrate Toujeo. [news release]. Cambridge, MA: Voluntis. July 18, 2017. Accessed July 22, 2017.


This is a nice example of something that we will be seeing more of in the years to come—well-developed digital companions to our medications. Many medications—injectable insulins for diabetes, inhalers for asthma and COPD—are complicated in their use and require titration algorithms or reminders to take the medications. In order to ensure that apps that are used in the delivery of medication meet the standards necessary for reliability, the FDA has issued a directive about the types of apps that require FDA approval. This app appears to be helpful both in assisting patients with titration algorithms and in motivating them to continue taking the medication, and may be reasonable to recommend to patients who are on one of the basal insulins listed above. —Neil Skolnik, MD