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Omnipod 5 | Omnipod 5 fda approval | Omnipod 5 release date | When will Omnipod 5 be available

Omnipod 5 Release: These 3 New Features Will Amaze You!

Omnipod 5 is the most recently developed model of the Omnipod system, which is manufactured by the innovative medical device company called Insulet Corporation. For those unfamiliar with the Omnipod devices, an Omnipod is a tubeless, non-stop external- insulin delivery system.

Omnipods are FDA approved and considered reliable and efficient forms of providing Diabetics a convenient, adaptable method of external insulin.

Difficulties with the production and absorption of insulin can be found in both Type 1 and Type 2 Diabetics.

Omnipod devices provide Type 1 Diabetics with the insulin that they cannot produce naturally, and they provide Type 2 Diabetics with additional insulin to overcome absorption struggles.

The Next Generation of Omnipod

Omnipod 5 is the second-generation of the ‘Pod’ system, developed by Insulet Corporation. Insulet kept all the great features found in their first-generation model, the Omnipod DASH, and
added some new technologies to the Omnipod 5.

Features of the Omnipod DASH and Omnipod 5 Include:

➤ Two Part System:
• (1) a Tubeless Pod (no tube to get tangled)
• (2) a Handheld Personal Diabetes Manager (PDM), for wireless insulin delivery programming.

➤Up to 72 hrs of Insulin Delivery
➤Placement Adaptable – Can be placed virtually anywhere on the body where typical insulin injections can be performed.
➤Waterproof – Pod can continue to function in approximately 25 feet of water for relatively 60 minutes.

Some of the NEW Features of Omnipod 5:

➤Dexcom G6 CGM (Continuous Glucose Monitor) Integrated
➤Smartphone Compatible
➤Fully Automated

Essentially, these new features allow for:

➤SmartAdjust™ Technology

The system updates every 5 minutes, allowing for automatic increases, decreases, or pauses in insulin delivery based on your customized target in order to help protect against highs and lows, day and night.

➤Activity Adjustments

When using the Activity Feature, the new Omnipod reduces insulin delivery when glucose typically goes low during times of increased activity (exercise, sports, etc.).

➤SmartBolus Feature

The built-in bolus calculator automatically incorporates your CGM data and trend(s).

The Omnipod 5 is also 34% smaller, 25% lighter, and 16% slimmer than Omnipod DASH. Also, the communication distance between the wearable Pod and the handheld Personal Diabetes Manager (PDM) has increased by 5 feet, compared to the Omnipod DASH.

How Long Does an Omnipod 5 Actually Last?

According to the officials at Insulet, the manufacturer of the Omnipod system, each pod of the Omnipod 5 series is intended to be utilized for 3 days, or 72 hours. After the 3 days, or 72 hours, the used pod is removed from the skin and a new pod is placed and activated. Ideally, each pod is made to deliver 72 hours of insulin, and is equipped with a notification alarm in order to alert the pod user that the 72-hour time-limit is coming to an end and/or has ended.

However, current Omnipod 5 users have reported that they have had pods last up to 8 additional hours past the 72-hour time limit; thus, giving a total of 80 hours of wearability. But, of course, results will vary from each individual. To ensure your Omnipod 5 stays on as long as possible, an adhesive patch is highly recommended. For something that will cover and hold the sensor firmly to your skin, check out the colorful selection of Omnipod Stickers at Not Just a Patch.

Approval & Availability of Omnipod 5

Omnipod 5 has been FDA approved as of January 2022, and is authorized to be use by individuals diagnosed with Type 1 Diabetes ages 6 year and older, at this time. Although the FDA approval indicates that the Pod is safe, effective, and is able to demonstrate sustained reduction in A1C, improved Time in Range (TIR), and very few occurrences of hypoglycemia, the Omnipod 5 is still in a Limited Market Release (LMR) mode.

When a device, such as the the new Omnipod, is in LMR mode it essentially means that the device has received approval from necessary health administrations, such as the FDA, based on the current
studies, surveys, and tests the device has gone through, but the release of the product is limited to a certain classification of individuals who are SAFE to use the device. In this case, ‘individuals diagnosed with Type 1 Diabetes ages 6 year and older’ are the LMR classification. Furthermore, issues including confirmation of medical necessity and insurance approval for the device can be significant aspects of the LMR mode as well.

When will Omnipod 5 be available? According to the Omnipod manufacturer Insulet, it will be available to the remainder of the diabetes community before the conclusion of the 2022. While the Omnipod 5 is making its way toward full market release, the Omnipod DASH is available for trial, which can allow for exploration of the Pod system. Once the Omnipod 5 is available, Omnipod DASH users have the option to upgrade to the newer version. Both Omnipod DASH and Omnipod 5 require a prescription from a physician. Omnipod DASH is currently available through a variety of local and mail-order pharmacies.

Pod Pricing – Omnipod 5 Price

Pricing for the Omnipod 5 varies based on health insurance coverage. However, Insulet, the Omnipod manufacturer, has announced that the new Omnipod, once fully released, will cost the same as Omnipod DASH. Omnipod DASH users pay, on average, less than $50 per month co-pay at the pharmacy for (10) pods.

Insulet encourages individuals to use their website to estimate potential costs of the Omnipod device(s). Please use the following link for more information: Omnipod Coverage. Currently, some of the Medicare part D plans, primarily those with higher co-payments such as Tier 3 and 4, cover Omnipod systems. Individuals with Medicare Part D should also verify their ‘access options’ regarding medical devices, as Medicare Part D deals primary with prescription drugs. For more information: Omnipod Medicare

Insulet also has a financial assistance program that may help eligible users cover the cost of an Omnipod system, regardless of their insurance provider. For more information: Omnipod – How to get financial assistance

According to the American Diabetes Association

American Diabetes Association – Trial/Study of Omnipod 5 – July 2021:
American Diabetes Association – Clinical Implementation of Omnipod 5 – April 2022: