FDA Clears Phone App for d-Nav Insulin Guidance Service

Hygieia, a digital insulin management company, announced Wednesday that the FDA had given clearance to a phone app that works with its d-Nav insulin guidance service, designed to help people with type 2 diabetes (T2D) achieve optimal insulin doses to better control blood glucose.

The company claims in a statement that the app is “the first insulin-management phone app able to titrate individualized doses for all types of insulin regimens, delivering recommendations directly to the patient.” Among its capabilities, it can connect to any glucose meter that shares data for the cloud, and it is available for both iOS and Android mobile phones.

The company, with headquarters in Livonia, Michigan, and Dundonald, Northern Ireland, aids patients by titrating individualized doses of insulin, which typically allow patients to use less insulin over time once they achieve glycemic control. The company’s website features a scenario from a patient who was using 90 units per day when he started with d-Nav and gradually increased insulin use during the first 2 months to 109 units. But then the patient’s insulin needs declined and reached 76 units by month 6.

The scenario states that without the support system offered by d-Nav, such a patient could not achieve these results without frequent office visits for insulin dose adjustments.

The system relies on cloud-based technology backed by a team of healthcare professionals, according to the statement. Proprietary algorithms use patients’ glucose readings to offer personalized adjustments and make dosing recommendations. The system has generated improved patient outcomes and cost savings over a 6-year period in Northern Ireland, and it has now been adopted by Blue Cross Blue Shield of Michigan (BCBSM). According to the company, at-risk patients with T2D enrolled in commercial BCBSM plans in southeast Michigan have access to the service.

Apps to assist patients with insulin dosing have existed for some time; the first product to offer personalized recommendations based on individual data was Welldoc’s BlueStar app, which was approved back in 2013. For years, FDA was reluctant to approve devices that did the dosing for patients, but that changed with the breakthrough decision to add a dosing indication to the Dexcom G5 continuous glucose monitor, which recognized how many people with diabetes were already using the technology.

Many more apps and insulin delivery devices that perform dosing for individual consumers are reaching the market, so much so that some believe the traditional insulin pump may become obsolete.