7. Drug & Device Updates

FDA Approves Tresiba® Label Updated With Data From Safety Outcomes Trial

FDA has approved an update to the prescribing information for Tresiba® (insulin degludec) to include cardiovascular outcomes and severe hypoglycemia study data.

In the multinational clinical trial DEVOTE, Tresiba® (insulin degludec injection) U-100 was compared to insulin glargine U-100, in individuals with inadequately controlled type 2 diabetes and atherosclerotic cardiovascular disease. Trial results showed non-inferiority of Tresiba® compared to insulin glargine with regard to major adverse cardiovascular events or MACE (defined as the first occurrence of cardiovascular death, non-fatal myocardial infarction or non-fatal stroke). Tresiba® also resulted in a 40% lower rate of severe hypoglycemia when compared to insulin glargine U-100. Blood sugar control between the two groups was similar at baseline and throughout the trial.

Tresiba® received its first regulatory approval in Japan in September 2012 and has since been approved in more than 80 countries globally. It is the only long-acting insulin approved for type 1 and type 2 diabetes in children as young as 1 year of age. It is available at strengths 100 units/mL or 200 units/mL in 3mL FlexTouch® pens.

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DarioHealth Receives FDA Nod for iPhone-Compatible Glucose Meter

The FDA has cleared DarioHealth‘s iPhone-compatible blood glucose monitoring system, enabling users to access the company’s Dario app on iPhone 7, 8 and X mobile devices. The product is designed to work with Apple’s latest smartphones, which feature a Lightning connector in place of a standard headphone jack.

Dario®is a personalized, pocket-sized, all-in-one glucose meter coupled with a robust real-time mobile app to manage diabetes quickly, efficiently and accurately. This all-in-one smart glucose meter allows testing blood glucose in seconds, directly on the user’s smartphone. Once connected to the mobile device, it allows to easily and accurately track, monitor and manage diabetes in real-time with the help of a simple to use Dario mobile app. Data can also be shared in real time with caregivers and healthcare professionals. The company had won FDA clearance for an Apple-compatible version of its blood glucose monitoring system in 2015 and later had won approval for systems designed for Android devices.

With the introduction of Lightning®-enabled device, Apple consumers can connect the Dario® smart glucose meter to the latest iOS handsets, including the brand-new iPhone X.

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