FDA Issues Clearance to Insulet’s Omnipod Dash for Effective Diabetes Management


Insulet has received FDA approval for commercialization of Omnipod Dash Insulin Management system for diabetic sufferers in United States. Before the full release of the system, a 6 month survey called DASH AHEAD Program will be conducted in United States. The launching of Omnipod Dash is anticipated in early 2019.

Omnipod Dash comprises a smartphone like handheld device called Personal Diabetes Manager (PDM) and an insulin pump. The PDM connects wirelessly with tubeless waterproof insulin pump worn on body that can hold upto 200 units of insulin. The PDM has modern simple & colorful touch-screen interface. This system helps to record the amount of insulin given in specified time. The Counter Next One blood glucose meter can be used to track the blood sugar level & calculate how much amount of insulin should be delivered to the patient. The doctor, care-taker or system user can access the data provided by glucometer & pump. This will help them to ensure proper insulin levels, and in turn, maintain patient’s good health.

The goal is to reduce daily strain on diabetic impacted people & minimize the system’s upfront cost. Make a note that only CONTOUR NEXT ONE Blood Glucose Meter from Ascensia Diabetes Care is currently compatible with the system that will transfer blood glucose readings to the Personal Diabetes Manager (PDM) wirelessly. It will be readily available within the Omnipod DASH System Welcome Kit for new customers. If a patient uses an alternative blood glucose meter with the Omnipod DASH System, it will not transmit the blood glucose readings to the Omnipod DASH PDM wirelessly.

Tessa Mellinger, a college student suffering from Type 1 diabetes who has been a part of DASH user testing process said, “I’m thrilled with the new Omnipod Dash System.” Further she added – “The PDM display is easy to read, the steps to managing basal rates are user friendly, and the food library is really helpful. The fact that it looks like a smartphone makes it cool to carry and may help eliminate those awkward questions from strangers.”

Jay Smith is a trained neuroscientist and holds over two decades of experience in biomedical research. Also, was a regular author for leading medical and pharma journals and offered educational consulting and medical writing relating to the industry. Currently, he works as a head of content development for leading media house and interviews leading medical professionals to put forth developments in healthcare industry for the technology professionals.


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