Insulet has announced the FDA approval of their new Omnipod® 5 insulin delivery system for use in people with type 1 diabetes who are two-years-old and older. With this device, Insulet will join Tandem and Medtronic in offering an Automated Insulin Delivery (AID) system.
The Omnipod® 5 is the first insulin delivery system to require
- No multiple daily injections
- No tubing
- No finger pricks*
- No PDM.
*Finger pricks should always be used if your symptoms don’t match the reading on your G6.
What is an AID system?
In the case of Insulet, their Automated Insulin Deliver system means integrating the Dexcom G6 Continuous Glucose Monitoring (CGM) System and a compatible smartphone (or your PDM) to automatically adjust insulin. This helps to protect against highs and lows.
Who can use the Omnipod® 5?
The Omnipod® 5 is approved for use in the United States for individuals six years old and older who have type 1 diabetes.
What is new in the Omnipod® 5?
The Omnipod® 5 remains a tubeless, pod system. The Bluetooth™ pods that were released with the DASH, now have been enhanced with SmartAdjust™ technology! This means that the pods can now work with the Dexcom G6 CGM, and the Omnipod® 5 mobile app (no PDM controller required)!
SmartAdjust™ receives a Dexcom CGM value and trend every five minutes. It then predicts where glucose will be 60 minutes into the future. Finally the system increases, decreases, or pauses insulin delivery using the user’s customized glucose target, helping to protect against highs and lows. The target range can be different depending on time of day.
DiabetesMine noted in an earlier article that the Omnipod® 5 will also include a “HypoProtect” feature. This feature is geared to prevent lows during exercise by temporarily setting the target to 150 mg/dL and minimizing basal insulin delivery.
Over the course of two or three Pods, the algorithm will begin to make more aggressive self-adjustments based on the results of the past several days. It will have a new foundational basal program set after about nine days.
Can you use the Omnipod® 5 without a CGM?
Yes, according to diaTribe, the Omnipod® 5 has three options for use.
You can use it in “automated mode”. This means that it will adjust insulin delivery automatically with a CGM connection.
You can use it in “manual mode”. In this case, the system will deliver insulin at pre-programmed rates regardless of whether the CGM is connected or not.
Finally there is “activity mode”. This is HypoProtect feature previously mentioned. It allows the user to temporarily set a glucose target of 150 mg/dL and suspend insulin delivery during exercise or other periods of increased insulin sensitivity or high risk of hypoglycemia.
Which cellphones can be used with the Omnipod 5?
At the moment, the Omnipod 5 website is showing that the remote bolus option is only available for the Samsung Gallaxy S10 (4G). You can check this link to see when more options are available.
What stays the same?
While the Omnipod® 5 comes with some incredible new features, it has kept many features that Podders have come to love.
It remains the same shape and size as the current pods. It can be worn for up to 3 days and holds up to 200 units of insulin.
If you don’t want to use a cellphone, you will be able to access a free Omnipod® 5 controller with your first prescription.
What else can we expect?
There is more coming for the Omnipod® 5! Insulet has promised that the Omnipod® 5 will work with the Freestyle Libre at one point in the future.
Can I upgrade from the Omnipod DASH® ?
Yes! According to the Insulet press release, if you are using the Omnipod DASH® , you will be able to upgrade to the Omnipod® 5 at no additional cost.
When can I get my Omnipod® 5?
According to Insulet, “Omnipod 5 will launch through the pharmacy channel, providing customer benefits of no contract, no commitment, and no obligation. In the coming days, Insulet will offer Omnipod 5 in a limited market release so that the Company can incorporate learnings to deliver a best-in-class product experience. Omnipod 5 is expected to be broadly available shortly after the limited market release.”