The Diabetes Community now has the world's first closed-loop system that automates insulin delivery without using plastic tubing attached to your body. And this new system will be the first to be approved by (FDA) to be monitored by a smartphone.
The Omnipod 5 system, which was first FDA-approved at the beginning of the year, will be fully available in the United States in early August 2022 for those aged 6 and up. Insulet Corporation of Boston developed this, marking the firm's entry into auto insulin delivery (AID).
To automate insulin delivery, the new system that combines the small white Omnipod patch pump with the Dexcom G6 CGM and a control system algorithm. Notably, the Omnipod 5 is the first system of its kind to receive FDA approval for mobile app control and insulin dosing directly from your smartphone, eliminating the need to always carry a separate controller unit.
"We believe that the Omnipod 5 will fundamentally change the market and the lives of people with diabetes," Insulet President and CEO Shacey Petrovic said. "This has been in the works for over a decade... It was not an easy road, with many technical obstacles and pandemic delays.
To have overcome each of these obstructions and being here, pushing the field forward by introducing unbelievable novel advanced technologies that bring many firsts to market, is the proudest moment of my career."
The launch of Omnipod 5, formerly known as "Omnipod Horizon," generates a lot of excitement, even if some people question the company's decision to sell this new system only through pharmacies at first.
What precisely is Omnipod 5?
The FDA approved this technology on January 28, 2022, just over a year after Insulet submitted the product to the agency. It is the fourth commercially available AID system in the United States, but it is the first that does not use tubing.
The Omnipod 5 system from Insulet is the most recent AID system, combining an insulin pump and CGM with a controlling algorithm that automatically adjusts insulin in response to predicted glucose levels. These are known as hybrid closed loop systems because they partially mimic what a healthy pancreas does automatically — but some user intervention is still required in terms of food intake and exercise.
Here are some of the key Omnipod 5 features you need to know.
The new Omnipod 5 capsules are the same size and shape as the existing DASH capsules, can be worn for up to 3 days, and can hold 85-200 units of insulin, but they are not identical capsules and are not backward compatible. When the insulin runs out or the 72-hour window expires, discard the pod and attach a new one. Waterproof to a depth of 25 feet for up to an hour.
This product was originally approved for people 6 years of age and older with type 1 diabetes (T1D). Insulin plans to release key test data soon for preschool age groups starting at 2 years old. Of course, younger kids can still get the new Omnipod 5 if doctors are willing to clear the label.
Diabetes type 2?
While the Omnipod 5 is not currently labeled for type 2 diabetes, Insulet tells DiabetesMine that it is currently conducting a clinical trial focused on T2D and will collaborate with the FDA on a larger study required for that expanded T2D indication.
Control either through a smartphone or a different controller.
In contrast to previous Omnipod versions, which required a separate controller device, Omnipod 5 users can control this new system directly from a smartphone app. Initially, only certain Android smartphones will be compatible, but it will eventually work with iPhones as well. Insulet will include a handheld controller with each person's first prescription for those who do not have a compatible smartphone to use exclusively with the Omnipod 5 app. The FDA did not require this, but the company chose to provide a controller to every customer who requested one.
Based on current and projected glucose values from the connected CGM, the algorithm is built directly into each Pod and makes auto-adjustments to basal (background) insulin rates every 5 minutes. It also considers insulin on board (IOB) that has already been dosed, as well as the user's recorded insulin sensitivity factors. Insulet refers to this automation as "SmartAdjust" technology.
Glucose objectives are adjustable in 10 milligrams per deciliter (mg/dL) builds up between 110 and 150 mg/dL, unlike some other first-generation AID systems, which start with fixed targets that cannot be altered. It also allows for different glucose targets at different times of day, with up to eight different programs running throughout the day.
The feature of activity.
This can be used when there is a high risk of low blood sugar, such as during exercise. You can raise the target glucose level to 150 mg/dL and reduce automated insulin delivery in 1-hour increments from 1 to 24 hours.
Correction boluses and food
You must still take a bolus dose for food and can manually deliver insulin corrections for higher blood sugars, but the smart algorithm will automatically adjust those boluses based on CGM trends.
No extended boluses:
Many insulin pumpers are accustomed to being able to deliver a portion of insulin over a longer period of time, but the Omnipod 5 does not support this. With "traditional" pump settings, you can disable the auto-mode and switch to a more manual mode, but this is not permitted when using the automated insulin capabilities. Insulet claims that clinical research shows that the smart algorithm in Omnipod 5 handles higher fat meals like pizza better than having someone guess how much insulin should be delayed over time.
Learning that adapts
After the first two or three Pods, the system learns a user's needs, with the smart algorithm making more aggressive self-adjustments based on results over the previous several days. A new foundational basal program takes about 9 days to set up.
Correction for sensor failures
. After at least 48 hours of wearing a Pod, the Omnipod 5 begins an adaptive basal rate based on what it's learned. If CGM data is not available at any time, the system enters a limited state of automation in which it decides whether your programmed basal rate or the adapted rate is more conservative and uses that.