Therapy Areas: Diabetes
Hygieia awarded US FDA's 510(k) clearance for first Phone App to enhance its Nav Insulin Guidance Service
21 February 2019 -

Digital insulin company Hygieia disclosed on Wednesday the receipt of the 510(k) clearance from the US Food and Drug Administration (FDA) for a phone app to further enhance its d-Nav Insulin Guidance Service among people with Type 2 diabetes.

The company said the phone app is available for both iOS and Android mobile phones as an aid in optimising insulin management among people with Type 2 diabetes.

According to the company, the first insulin-management phone app is able to titrate individualised doses for all types of insulin regimens, delivering recommendations directly to the patient. It is also the first insulin-titration app that can connect to any glucose meter that shares data with the cloud.

In conjunction, the company's d-Nav Insulin Guidance Service combines smart cloud-based technology and a small team of healthcare professionals to support primary care physicians and help people with diabetes achieve improved health through better glycemic control. Using proprietary insulin-titration algorithms and patients' individual blood glucose readings, the d-Nav Service provides personalised insulin adjustments to enhance and simplify dosing.

Additionally, the company's d-Nav Service is currently being offered in the US by Blue Cross Blue Shield of Michigan (BCBSM). It is available at no cost and with no co-pays to BCBSM members with Type 2 diabetes in its fully insured commercial plans, starting with at-risk populations in Southeast Michigan.

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