Hygieia's cloud-based insulin titration app wins 510(k) clearance

The tool was also the focus of a multi-center, randomized, controlled trial published last week in the Lancet.
By Dave Muoio
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Earlier this month, Hygieia’s d-Nav Insulin Guidance Service — an app that titrates insulin doses for individual Type 2 diabetes patients, regardless of their regimen type — received 510(k) clearance from the FDA.

The cloud-based service leverages proprietary algorithms, users’ individual blood glucose data and a small team of in-house health professionals to generate and deliver insulin dosage recommendations. Users enter their glucose event data and receive the recommendations directly through the app, which can also connect to the patient’s glucose meter to collect relevant data.

The d-Nav Insulin Guidance System was also the subject of a multi-center study published in the Lancet late last week.

Here, researchers assigned a cohort of 181 Type 2 diabetes patients aged 21 to 70 years with an HbA1c concentration between 7.5 percent and 11 percent to receive the d-Nav app and healthcare professional support (n  = 93) or professional support alone (n = 88). After six months, there was a significantly greater mean decrease in HbA1c among the intervention group (1 percent versus .3 percent, p < .0001), although the rate of monthly hypoglycemic events was statistically similar between each group.

What’s the impact

Incorrect insulin dosing can lead to severe hypoglycemic or hyperglycemic events, and manually managing any adjustments in blood sugar can take a toll on patients and providers alike. Hygieia’s app stands to reduce that burden with its easy-to-access service and compatibilities with external devices.

"This FDA clearance is an important milestone in our mission to improve and simplify insulin management by making the d-Nav Service as convenient, simple and accessible as possible for patients and physicians who could benefit from it," Eran Bashan, Hygieia CEO, said in a statement. "Insulin therapy is critical to the health of more than 8 million people in the United States, but it is often ineffective, largely because it requires continual, personalized adjustment that is not practical for physicians and not manageable for patients. The d-Nav Service, including the user-friendly phone app, makes insulin therapy more effective, less time intensive and less costly for everyone involved.”

What’s the trend

While Hygieia’s product has been putting up new supporting clinical data for some time, other digital diabetes companies are also looking to reduce the strain on patients and providers. Medtronic and IBM Watson’s Sugar.IQ diabetes assistant app recently gained a feature that uses artificial intelligence to predict upcoming low glucose events, and Novo Nordisk’s soon-to-be-released insulin pens already have integrations with Glooko’s diasend platform and Abbott’s Freesyle Libre system.

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