FDA Approves Insulia Diabetes-Management Software

Prescription device provides insulin dosing recommendations

Paris-based company Voluntis has received FDA 510(k) clearance for the Insulia Diabetes Management Companion, a global digital device for patients with type-2 diabetes who are being treated with insulin. The prescription-only medical device works with Sanofi’s Lantus (insulin glargine injection) and Novo Nordisk’s Levemir (insulin detemir [rDNA origin] injection). A patient may use the application via a web portal, on a smartphone, or on a tablet. The device will be available in the first half of 2017.

The Insulia device provides patients with insulin dose recommendations and educational coaching messages in response to blood glucose values and other diabetes-related data. The device also supports a variety of treatment plans and evidence-based insulin adjustment rules used in routine clinical practice.

First, the clinician sets up a personalized treatment plan based on the patient’s profile, insulin prescription, and blood glucose targets. This enables the Insulia device to provide automated insulin dosing recommendations to the patient. The dose-adjustment algorithm is embedded in the application and is accessible to the patient via a web portal or via iOS and Android smartphones and tablets. The patient data are automatically shared with the health care team, who can remotely monitor the patient’s progress.

Approximately 30 million Americans and 400 million people worldwide have diabetes. Ninety percent of these individuals have type-2 diabetes and are often treated with basal insulin. Despite being provided with effective medications, more than half of diabetes patients do not meet the recommended targets for glycemic control. Major contributing factors include challenges with insulin initiation and titration. Because of the complications associated with diabetes, its total annual cost in the U.S. is $300 billion. Optimizing adherence to diabetes medications is recognized as one of the most effective ways of controlling disease expenditures.

Sources: Voluntus; December 6, 2016; and FierceBiotech; December 6, 2016.