FDA Clears Omnipod DASH System for Diabetes Management

Insulet announced that the Food and Drug Administration (FDA) has granted 510(k) clearance for its Omnipod DASH Insulin Management System, a new tubeless, wearable insulin pump for diabetes management. 

The Omnipod DASH system consists of a discreet, tubeless, waterproof Pod which is worn on the body, and the Personal Diabetes Manager (PDM), a handheld wireless device used to control the Pod. The system can be used with the Contour Next One Blood Glucose Meter for wireless transfer of blood glucose readings to the DASH PDM. The pump can hold up to 200 units of U-100 insulin and delivers continuous insulin through customizable basal rates and bolus doses. 

Through Bluetooth technology, the user can connect to the  Omnipod DISPLAY and Omnipod VIEW apps. Both apps provide patients and caregivers access to insulin therapy on their smartphones. The DISPLAY app allows patients to monitor their PDM data whereas the VIEW app allows caregivers to monitor someone’s treatment progress; PDM status can be shared with up to 12 friends or family members. 

The Contour Next One Blood Glucose Meter is the only compatible meter that will transfer glucose readings to the PDM. Use of alternative blood glucose meters with the Omnipod DASH system will not allow wireless transmission of glucose readings to the PDM. Currently, no continuous glucose monitors (CGMs) have integrated functionality with the Omnipod DASH system. 

The Pods are waterproof up to 25 feet for 1 hour; the PDM, however, is not waterproof. Pods should be changed every 3 days. A food library, CalorieKing, is also included in the system with carbohydrate information for up to 80,000 foods. 

The Omnipod DASH system is anticipated to launch in early 2019. 

For more information call (800) 591-3455 or visit MyOmniPod.com.