Devices & Diagnostics, Patient Engagement

Basal insulin dosage management tool for Type 2 diabetes gets greenlight from FDA

Physicians prescribe the app developed by Voluntis to patients as part of an effort to help them manage their chronic condition.

Voluntis Insulia app

Voluntis Insulia app


A connected therapeutics company has received 510(k) clearance from the U.S. Food and Drug Administration for a physician-driven dosage management platform for basal insulin geared for Type 2 diabetes patients. Voluntis, a French company with offices in Paris and Cambridge, Massachusetts, also earned a CE Mark from European regulators for the product, called Insulia, according to a company news release emailed to MedCity News.

Voluntis CEO and Founder Pierre Leurent explained how the product works in a phone interview. Physicians prescribe the app to patients. They create accounts for patients through a portal. An activation code is generated that allows patients to access the tool through a mobile app or through the portal. Leurent said 1,000 patients have used the product in clinical trials.

Leurent added that Insulia is the first medical mobile application supporting Type 2 diabetes patients treated with basal insulin. The app, available for Android and iOS networks, is expected to be available in the first half of 2017.

The goal of basal insulin is to help people keep glucose levels in check when they’re not eating. There are two types of basal insulin — intermediate which lasts several hours and long-acting which is intended to last 24 hours. Factors that physicians review before deciding which one to prescribe include activity level, body size, hormone levels, diet, and how much insulin the patient’s pancreas still produces.

Insulia provides automated insulin dose recommendations based on the patient’s treatment plan, insulin prescription, and blood glucose goals. Patients receive coaching messages in response to blood glucose values and other diabetes-related data, the statement said.The dose adjustment algorithm is embedded in the application. The app provides support for a wide variety of treatment plan configurations and evidence-based insulin adjustment rules used in routine clinical practice, the statement said.

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The app also supports remote monitoring of patients since the data is automatically shared with their care team, who can monitor the patient’s progress and send notifications when necessary.

“Only half of patients reach their target goal with insulin treatment,” Leurent observed. “We are committed to providing the best solutions to guide pats on treatment pathway

In 2014, Voluntis closed a $29 million Series D round led by Bpifrance Large Venture and international venture capital firm Innovation Capital. Other investors that took part in the fundraise included Qualcomm Ventures, CapDecisif Management, CM-CIC Capital Innovation and Sham. At that time, Voluntis said it would use the funding to accelerate the development of its diabetes management solution, advance new programs in other chronic diseases and ramp up its U.S. operations.

Voluntis previously received a CE Mark in 2013 for its Voluntis Insulin Therapy Manager, which is branded as Diabeo, a registered trademark of Sanofi.

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