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Omnipod® 5 Automated Insulin Delivery System

Omnipod® 5:
Automated Insulin Delivery System, First Tubeless System with Smartphone Control

On January 28, 2022, Insulet announced the FDA clearance of the Omnipod 5 Automated Insulin Delivery System for people with type 1 diabetes aged 6 years and older, the first and only tubeless automated insulin delivery (AID) system in the US with compatible smartphone control and Dexcom® G6 Continuous Glucose Monitor (CGM) System integration to help protect against highs and lows.¥

Just like Omnipod DASH®, it includes a waterproof* tubeless insulin Pod that can be worn almost anywhere you’d inject insulin. Each Pod still lets you trade multiple daily injections for up to 3 days (72 hours) of continuous insulin. But now, it’s automated, CGM integrated, and highly anticipated—helping to simplify life in so many ways.

*The Pod has an IP28 rating for up to 25 feet for 60 minutes. The controller is not waterproof.

3 Simple Parts

To the Omnipod 5 Automated Insulin Delivery System

Omnipod 5 App*
Take full control of the Pod from the Omnipod App on a compatible smartphone* or use the free controller, provided at no additional cost with your first prescription.

*For a list of compatible smartphone devices visit omnipod.com/compatibility.

Pod 
Tubeless, wearable and waterproof, the state-of-the-art Pod, with built in SmartAdjust technology, sits right on your body and automatically adjusts insulin delivery for up to 3 days or 72 hours. 

Dexcom® G6 CGM  System 
Continuously sends glucose readings to the Pod, so you can get real-time data without the fingersticks*. Dexcom G6 is sold separately. 

*Fingersticks required for diabetes treatment decisions if symptoms or expectations do not match readings.

Always adjusting, so you don’t have to

With SmartAdjust technology, Omnipod 5 and the Dexcom G6 CGM are in constant communication, enabling automatic insulin adjustments to help improve time in range.¥

You can use the Omnipod 5 App on a compatible smartphone (see full list of compatible smartphones) to control the Omnipod 5 System* when you need to, but you won’t always have to. Now that they talk wirelessly and automatically, Dexcom G6 and Omnipod 5 offer new levels of freedom to the Omnipod family, without compromising on the basics that are anything but.

* Dexcom G6 App is needed to control the G6 CGM

What’s New:

SmartAdjust™ technology

Every 5 minutes, the system automatically increases, decreases, or pauses insulin delivery based on your customized target—helping to protect against highs and lows¥, day and night.

Activity feature

Activity with a few finger taps. When using the Activity feature, Omnipod 5 reduces insulin delivery when glucose typically goes low, like when exercising.

SmartBolus feature

The only AID system with a built-in bolus calculator that automatically incorporates your CGM data and trend, so you don’t have to.

What’s Still True:

No more multiple daily injections

No more multiple daily injections when managing insulin.

Waterproof* device

Wear the Pod in the shower, the ocean, or running in the rain.

*The Pod has an IP28 rating for up to 25 feet for 60 minutes.

No tubes to get in the way

Walk freely through every open door, leaving doorknobs in your dust. No belts, fanny packs, or pockets required.

Dash into Omnipod 5!

Start today with a free 30-day Omnipod DASH trial, and upgrade to Omnipod 5 as soon as its available and covered for you, for no additional cost.*

*Only available for users with valid prescription and coverage through their pharmacy benefit. Upgrades subject to user’s insurance coverage. Subject to co-pays as required by insurance coverage.

Control it all from a compatible smartphone

To simplify things even more, you can control the whole Omnipod 5 System from a compatible smartphone through the Omnipod 5 App. With the Pod and CGM continuously talking, they’ll do most of the work automatically, but, when you need to, you can control your insulin delivery, give yourself a mealtime dose, and easily share data (see full list of compatible smartphones).

If your phone isn’t compatible, you can use the free Omnipod 5 Controller, which comes with your first prescription. 

 

Get Started Today

Omnipod 5 is now FDA cleared, but not yet available. As we take time to expand insurance access, we encourage you to try Omnipod DASH® free for 30 days.

With our OmnipodPromise™ , you can start on Omnipod DASH today with no contract or commitment to experience Pod therapy and learn the basics. Once Omnipod 5 is available and you have coverage, you can easily upgrade.

New to Omnipod?
Already on Omnipod?
 

When can I get Omnipod 5?

Omnipod 5 will launch through the pharmacy channel, providing customer benefits of no contract, no commitment, and no obligation. At this time, Omnipod 5 is in an industry standard Limited Market Release. This will enable us to ensure a best-in-class product experience. We are looking forward to making Omnipod® 5 available to the diabetes community upon full market release which is expected shortly after the limited market release. For more information check out the Omnipod 5 frequently asked questions.

¥. Brown S. et al. Diabetes Care. 2021;44:1630-1640. Prospective pivotal trial in 240 participants with T1D aged 6 - 70 yrs. Study included a 14-day standard therapy (ST) phase followed by a 3-month Omnipod 5 hybrid closed-loop (HCL) phase. Mean time in range (70-180mg/dL) in adults/adolescents and children as measured by CGM: ST = 64.7%, 3-mo Omnipod 5 = 73.9%, P<0.0001; ST = 52.5%, 3-mo Omnipod 5 = 68.0%, P<0.0001, respectively. Mean time > 180 mg/dL (12AM-6AM) as in adults/adolescents and children, ST vs. 3-mo Omnipod 5: 32.1% vs. 20.7%; 42.2% vs. 20.7%, P<0.0001, respectively. Mean time >180 mg/dL (6AM -12AM) in adults/adolescents and children, ST vs. 3-mo Omnipod 5: 32.6% vs. 26.1%; 46.4% vs. 33.4%, P<0.0001, respectively. Median time in <70 mg/dL (12AM-6AM) in adults/adolescents and children, ST vs. 3-mo Omnipod 5: 2.07% vs. 0.82%,P<0.0001; 0.78% vs. 0.78%, P=0.0456, respectively. Median time <70 mg/dL (6AM-12AM) in adults/adolescents and children, ST vs. 3-mo Omnipod 5: 1.91% vs. 1.08%, P<0.0001; 1.17% vs. 1.62%, P=0.2545, respectively. Results measured by CGM.

Risk Statement
The Omnipod 5 Automated Insulin Delivery System is indicated for use by individuals with type 1 diabetes mellitus in persons 6 years of age and older. The Omnipod 5 System is intended for single patient, home use and requires a prescription. The Omnipod 5 System is compatible with the following U-100 insulins: NovoLog®, Humalog®, and Admelog®. 

The Omnipod 5 ACE Pump (Pod) is intended for the subcutaneous delivery of insulin, at set and variable rates, for the management of diabetes mellitus in persons requiring insulin. The Omnipod 5 ACE Pump is able to reliably and securely communicate with compatible, digitally connected devices, including automated insulin dosing software, to receive, execute, and confirm commands from these devices. SmartAdjust™ technology is intended for use with compatible integrated continuous glucose monitors (iCGM) and alternate controller enabled (ACE) pumps to automatically increase, decrease, and pause delivery of insulin based on current and predicted glucose values. The  Omnipod 5 SmartBolus Calculator is intended to calculate a suggested bolus dose based on user-entered carbohydrates, most recent sensor glucose value (or blood glucose reading if using fingerstick), rate of change of the sensor glucose (if applicable), insulin on board (IOB), and programmable correction factor, insulin to carbohydrate ratio, and target glucose value. 
 

WARNING: SmartAdjust technology should NOT be used by anyone under the age of 6 years old. SmartAdjust technology should also NOT be used in people who require less than 6 units of insulin per day as the safety of the technology has not been evaluated in this population. 

The Omnipod 5 System is NOT recommended for people who are unable to monitor glucose as recommended by their healthcare provider, are unable to maintain contact with their healthcare provider, are unable to use the Omnipod 5 System according to instructions, are taking hydroxyurea as it could lead to falsely elevated CGM values and result in over-delivery of insulin that can lead to severe hypoglycemia, and do NOT have adequate hearing and/or vision to allow recognition of all functions of the Omnipod 5 System, including alerts, alarms, and reminders. Device components including the Pod, CGM transmitter, and CGM sensor must be removed before Magnetic Resonance Imaging (MRI), Computed Tomography (CT) scan, or diathermy treatment. In addition, the Controller and smartphone should be placed outside of the procedure room. Exposure to MRI, CT, or diathermy treatment can damage the components. Visit www.omnipod.com/safety for additional important safety information.


WARNING: DO NOT start to use the Omnipod 5 System or change settings without adequate training and guidance from a healthcare provider. Initiating and adjusting settings incorrectly can result in over-delivery or under-delivery of insulin, which could lead to hypoglycemia or hyperglycemia.

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