FDA clears Hygieia’s ‘GPS for insulin’ diabetes management app

The FDA has greenlighted a mobile app from Hygieia to be used as part of d-Nav, its insulin management service. The prescription-only app is cleared for use as an aid in optimizing insulin doses for people with Type 2 diabetes and connects to glucose meters that share data with the cloud.

The app will be part of Hygieia’s d-Nav Insulin Guidance Service, which uses cloud-based technology and a team of healthcare professionals to support people with diabetes and their primary care physicians better control their disease. The service uses insulin-titration algorithms and patients’ individual blood glucose readings to make adjustments to each patient’s insulin dosing. Patients can use the app to log glucose event data and receive their recommended dose. 

“If we look at just outcomes, insulin is not working,” said Hygieia CEO Eran Bashan. “Two-thirds of people using insulin have a hemaglobin a1c level above 7, the goal set by the [American Diabetes Association], and one-third have an a1c level above 9.” 

While some might argue that poor outcomes are due to poor adherence on the patient’s part, it actually has to do with dosing, Bashan said. Patients tend to be underprescribed, that is, they are prescribed an inadequate dose. Livonia, Michigan-based Hygieia was founded to bring forth a better way to manage insulin and improve outcomes for people with diabetes and everybody else that’s involved in their care, he said. This includes primary care physicians, who make up the bulk of doctors treating people with diabetes. 

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The d-Nav app will provide patients access to Hygieia’s service, which uses a network of specialty clinics to offer insulin management services in a similar model to dialysis centers, Bashan said. Doctors in Hygieia’s clinics will prescribe the app and supervise treatment, but the d-Nav app “does most of the heavy lifting.” 

Bashan likens it to a GPS navigation app: “You drive around and all the navigation app tells you is to turn right or turn left. It doesn’t actually drive the car. To explain that it gives you directions doesn’t sound that impressive, but when you land in a new city for the first time and you need to get to a specific place... you know it will get you there. It gives you confidence,” he said. “That’s what d-Nav does for patients. It gives them confidence that they’re on the right track and taking the right doses. If they take a wrong turn, it will recalculate and will do so as often as needed.” 

The d-Nav service will be offered in the U.S. through a partnership with Blue Cross Blue Shield of Michigan at no cost to fully insured people with Type 2 diabetes. The insurer and Hygieia are “exploring opportunities to make the d-Nav Service available to other populations and markets,” the company said in a statement. Hygieia’s goal is to have clinics all over the U.S., and hopes to open some up in two to five states over the next year or two, Bashan said. The service has already been in use in Northern Ireland for six years, the company says. 

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Though d-Nav isn’t the first diabetes management app out there, Hygieia claims it is the first to be able to titrate doses of all types of insulin regimens and also the first to connect to any glucose meter that shares its data with the cloud. 

Paris-based Voluntis launched its Insulia app in December 2016 to be used with two types of basal insulin—Sanofi's Lantus and Novo Nordisk’s Levemir. In July 2017, the company scored U.S. and EU approval to add Sanofi’s Toujeo to the mix. And in June last year, DreaMed Diabetes earned the FDA OK for its decision support software, which assists healthcare providers with the treatment of Type 1 diabetes patients that use insulin pumps and continuous glucose monitoring.