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Two Unique Diabetes Management Systems Go Live

Dec 17, 2016

Possible future of diabetes management for the masses may have finally arrived, but will patients use the programs and will insurers pay?

Two new novel diabetes management platforms, the direct-to-consumer One Drop Premium and the prescription-only Insulia Diabetes Management Companion, have been newly licensed in both the United States and Europe.  Both technologies received both U.S. Food and Drug Administration (FDA) 510(k) clearance and CE mark approval on December 6, 2016. (Watch our video interview with Jeffrey Dachis, Founder and CEO of One Drop.)


OneDropThe “One Drop Premium” is a monthly subscription service that features a sleek blood glucose monitor along with at-home delivery of unlimited test strips and other testing supplies. It also includes Apple iOS, Apple Watch, and Android diabetes management apps that include in-app 24/7 on-demand access to a personal certified diabetes educator (CDE) and a diabetes education and management program.

The apps “allow you to log in and analyze glucose, food, meds, and activity all in one place; set daily diabetes management goals; track daily progress; and interact with a worldwide community of people living with diabetes,” One Drop’s CEO Jeffrey Dachis told DiabetesinControl.com Medical News.

Currently, One Drop is fully integrated with the Apple iOS and Watch apps, allowing for users to sync data from other health apps, including continuous glucose monitors (CGMs), Bluetooth meters, and other food and activity trackers. The integration also allows users to share their data with their healthcare providers.

“We look forward to bringing the same integrated experience to Android very soon,” Dachis said.

One Drop is not currently covered by any U.S insurance plans. The total out-of-pocket cost is around $33 to $40 a month depending on subscription plan.

According to Dachis, One Drop’s approach “refreshingly focuses on getting buy-in from patients: design aesthetics, unlimited test strips, and an emphasis on social networking. I’m excited for any solution that aims to build enthusiasm for improving the care for those with diabetes.”

Jeffrey Dachis discusses how his own experience with type one diabetes led him to develop the One Drop diabetes app to help other people with diabetes improve self-care. See the video and read the transcript.

The other diabetes management system approved by the FDA is the Insulia® Diabetes Management Companion, a new prescription-only medical device designed to support effective diabetes management of adults with type 2 diabetes treated with long-acting basal insulin, which can ease basal insulin dosing for type 2 diabetes patients. Insulia provides patients with insulin dose InsuliaLogorecommendations and educational coaching messages based on blood glucose values and other diabetes-related data. It enables a wide variety of treatment plan configurations that are based on scientifically supported and well-accepted insulin adjustment rules. Insulia is accessible to the patient via a web portal or on iOS and Android mobile devices (smartphone or tablet). All patient information is automatically shared with a health care team to allow for monitoring of patient progress. They can then send personalized notifications.

Self-monitoring blood glucose and self-managing insulin doses is cumbersome and challenging for a majority of patients. As a result, harnessing new and reliable technologies to support patients in safely managing insulin dosing while keeping in touch with a health care team could be well received by providers and patient communities.  Type 2 diabetes is a complex condition, especially for people who have transitioned to insulin therapy. “This simultaneous regulatory clearance of Insulia, both in the United States and Europe, is a unique achievement in digital health and the culmination of many years of hard work,” said Pierre Leurent, founder and CEO of Voluntis, the makers of Insulia.

Voluntis’s system appears to address a key pain point in the current physician-patient interaction: Guided insulin dose titration. The current methodology it hopes to replace is complex and either errs toward oversimplified instructions or relies heavily on frequent communication.  A key challenge will be to convince doctors to actually change their practice behavior and give Voluntis a try.  Insulia is expected to be available in the first half of 2017.