Omnipod 5 Is Now Approved For Type 1 Diabetes

Super Cool Omnipod 5 Insulin Pump is Here for Type 1 Diabetics!

The Omnipod 5 has received FDA approval for diabetics with type 1 disease. In 2022, consumers will be able to purchase the tubeless insulin pump, the Dexcom G6 glucose monitor, and the smartphone app.

As of the middle of 2022, the Omnipod 5 AID system from Insulet has been granted FDA approval. It is approved for diabetics with type 1 who are 6 years old or older.

The pivotal trial that led to FDA clearance for Omnipod 5 demonstrated that the product was both safe and effective, which is the trifecta of clinical results that is required for clearance.

In the pivotal trials of Omnipod 5, children aged 6 to 13 years old saw improvements in both their time in range (almost four additional hours per day in range) and their A1C (from 7.7 percent to 7.00 percent). Adults aged 14 and older saw an increase in their time in range from 65 percent to 74 percent, which equates to over two hours per day in range, as well as a decrease in their A1C from 7.2 percent to 6.8 percent. In both groups, the amount of time spent above the range (above 180 mg/dL) was reduced.

What Is Omnipod 5 Composed Of:

The Omnipod 5 is composed of these three components:

1. An insulin pump that is tubeless, wearable, and has an algorithm. The Pod has the capacity to store 200 units of rapid-acting insulin for a duration of three days. If you want to learn about other pumps and compare them please click here.

2. Dexcom G6 CGM (CGM).

The Insulet Omnipod 5 mobile app can either be pre-loaded on controllers or downloaded to phones. Both options are available. Control of both basal and bolus rates is possible via smartphone with the Omnipod 5 app.

In order for the continuous glucose monitor (CGM) and the pump to make adjustments to insulin dosing based on glucose levels, all automated insulin delivery systems require an algorithm. The Pod of the Omnipod 5 comes equipped with SmartAdjust already installed.

How is Omnipod 5 Different Than Other Insulin Pumps?

This is the first automated insulin delivery system that incorporates the algorithm directly into the pump itself. This enables the user to continue using the system in automated mode even if the smartphone or controller runs out of battery power. The Omnipod 5 is the first automated insulin delivery system that delivers insulin through a patch pump rather than a pump with tubes and is controlled by a smartphone.

Protecting against highs and lows and maintaining glucose levels within a healthy range even while the patient is sleeping is made possible by SmartAdjust's ability to automatically adjust insulin delivery by increasing, decreasing, or pausing it at regular intervals of five minutes.

The user has the ability to adjust their glucose target in 10 mg/dL increments from 110 to 150 mg/dL, and the algorithm of the system takes into account the amount of insulin that is currently on board.

Omnipod 5 modes

The system can operate in a variety of modes;

When using a CGM in the automated mode, insulin delivery is automatically adjusted.

Independent of the CGM connection, insulin is delivered at the pre-programmed rates when using the manual mode.

In activity mode, insulin delivery is stopped, and the glucose level is maintained at 150 mg/dL. This mode should be used during exercise or other times when insulin sensitivity is high or when there is a higher risk of hypoglycemia.

The CGM and the Pod are linked together using Bluetooth, and because the SmartAdjust algorithm is stored in the Pod, the system can continue to function even if the controller or the phone loses its ability to receive power (or moves out of bluetooth range).

Is It Available To Purchase?

As of June 2022, the Omnipod 5 can be obtained legally with a doctor's prescription.

What Is The Cost Of Omnipod 5?

The Omnipod 5 app, whether it's on the controller or a smartphone, is completely free. The price of a pod prescription is different for each insurance plan.

Insulet reports that the price of the Omnipod 5 is the same as the price of the Omnipod DASH and that it offers equivalent insurance coverage. The website for Omnipod includes a section on insurance coverage.

When we think about why people don't adopt these technologies, despite the fact that they increase Time in Range and achieve better outcomes and quality of life, it's because they're complex and expensive to use. Despite the fact that they do all of these things, people don't adopt them.

Through the Insulet Omnipod Promise program, more than 250,000 people who already use Omnipods will be able to receive a free upgrade to the Omnipod 5 system.

People who are interested in trying tubeless technology are given the opportunity to try out Omnipod DASH free of charge for a period of thirty days, and they will be able to upgrade to Omnipod 5 with a prescription to their local pharmacy once it is commercially available and covered by insurance.

What's different about the new Omnipod 5?

Integration with the Dexcom G7 CGM, which does not yet have clearance from the FDA, is currently in the works. Insulet and Abbott are business partners; consequently, integration with Freestyle Libre continuous glucose monitors (CGMs) may be on the horizon.

Why So Many People With Diabetes Prefer Omnipod?

The Pod is a tubeless, wearable delivery device that can replace up to 14 injections with just one Pod*. It does this by dispensing the medication directly into the patient's body. Put an end to the jumbled tubes and multiple daily injections you had to endure.

The Math: Simplify mealtime math with the built-in bolus calculator and CalorieKing® food library (English only/DASH only) with carb counts and other nutritional information. Both of these features are exclusive to DASH.

The App: The Omnipod 5 App allows you to have complete control over your device by using a smartphone that is compatible with it. Through the use of a smartphone, you are able to monitor the insulin data of those you care about with Omnipod DASH.

About the author

Dr. Ahmet Ergin is the author of The Ultimate Diabetes Book and the Founder of the SugarMD youtube channel. He practices in Port Saint Lucie, FL as an endocrinologist physician.