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Omnipod Insulin Delivery System Receives FDA Clearance

Jul 28, 2018
 

The Omnipod Dash device approved for commercialization and release in the U.S. by mid-2018.

Insulet Corporation, a medical device company, and creators of the insulin delivery system Omnipod Dash™,  just received FDA clearance for commercialization in the United States. At the moment, the 6-month limited release, referred to as the DASH AHEAD Program, will allow the company to prepare for the full launch in 2019.

Omnipod® is quite small, about half the width of a credit card, and adheres discretely to the skin. The durable device can be worn in water, but is only rated at a depth of 25 feet for up to 60 minutes. If submerged for an extended period of time, users should check to make sure adhesive remains intact. This feature is helpful for those living more active lifestyles.

Omnipod is positioned in areas you would normally give a shot (i.e. buttock, thigh, back, abdomen, backside of arm, etc.) and can be worn up to 72 hours. Omnipod is prepared in three steps: 1) fill the pod with U-100 rapid-acting insulin analog with the fill needle and syringe, 2) apply the pod, and 3) press the start button, which inserts a flexible cannula and begins delivering insulin at a preset rate programmed in the Personal Diabetes Manager (PDM). Each pod requires a minimum of 85 units to work and can hold a maximum of 200 units. This system administers both basal and bolus insulin.

Omnipod is different from more traditional insulin delivery systems (i.e. pumps) in that it does not require any tubing and connects wirelessly to a handheld device, or a PDM. As indicated in a recent press release, Insulet made some updates to the system, focusing specifically on the PDM component of the two-part system. The pod will now connect to a slimmer PDM by Bluetooth connection. Additionally, the handheld device received a makeover, looking and functioning like a “locked” Android smartphone with touchscreen capabilities.

Modifications to the glucose monitor were also made. Previously the device contained an integrated FreeStyle glucose meter, which fit into a much bulkier design. Now the PDM will connect wirelessly to an Ascensia Contour Next One glucose meter. Patients using the older system will have to adapt to this change. Results of glucose readings will be sent directly to the PDM Dash device and will be used to calculate bolus doses. Insulet hopes users feel more at ease with using the device because it mimics the smartphones that most carry with them on a daily basis.

Additional features are the Omnipod View display app, which receives data from the PDM and the Omnipod VIEW app, which allows up to 12 followers to view the information gathered, a feature that is helpful for caregivers and parents. According to Insulet, the app can only be used by iOS devices, but they hope to expand the app to accommodate Android smartphones.

These changes aim to modernize and simplify insulin administration. Some speculate the updates will eventually yield a system consisting of a user’s own smartphone and the pods. But for now, eligible patients looking to update their insulin delivery will have to wait for the limited market release and the eventual full launch of the device in early 2019.

Practice Pearls:

  • The U.S. Food & Drug Administration just approved Omnipod Dash for commercialization.
  • Insulet, makers of the Omnipod system, will have a 6-month limited market release beginning sometime in 2018.
  • The new Omnipod Dash device aims to update the previous version. The pods remain the same, however changes were made to the Personal Diabetes Manager. The major differences include: 1) PDM will connect to the tubeless pods by Bluetooth, 2) the new PDM device, a slim “locked” Android smartphone, replaces the previous bulkier version, 3) the previous FreeStyle glucose monitor has been replaced with the Contour Next One meter and is no longer integrated into the PDM device.
  • Detailed information about the Omnipod Insulin Management System can be found at https://www.myomnipod.com/.

References:

Levine, B. and Brown, A. FDA Clears Insulet’s Omnipod Dash Handheld with Bluetooth. diaTribe Learn. 8 May 2018. Available from: https://diatribe.org/fda-clears-insulets-omnipod-dash-touchscreen-handheld-bluetooth?utm_source=diaTribe&utm_campaign=6ba0cbbbc5-EMAIL_CAMPAIGN_2018_m166&utm_medium=email&utm_term=0_22467a8528-6ba0cbbbc5-150251305.

Brown, A. and Serino, M. Diabetes Tech on the Horizon Part 2 – New Insulin Delivery Systems Coming in 2018. diaTribe Learn. 11 December 2017. Available from: https://diatribe.org/diabetes-tech-horizon-new-insulin-delivery-systems-coming-2018#insulet.

Omnipod: Insulin Management System. Insulet Corporation. 2018. Available from: https://www.myomnipod.com/.

Kaytie A. Weierstahl, Pharm.D. Candidate, LECOM School of Pharmacy