About the Omnipod® 5 Automated Insulin
Delivery System with Compatible Smartphone
Control for Type 1 Diabetes
Meet the Omnipod® 5 Automated
Insulin Delivery System
The Omnipod® 5 Automated Insulin Delivery System is the first and only FDA-cleared, automated, tubeless insulin delivery System for people with type 1 diabetes 6 years of age and older. It works with the Dexcom G6® Continuous Glucose Monitor (CGM) System*, so it's always tracking your glucose levels and automatically adjusting your insulin dose.1
And just like the the Omnipod DASH® Insulin Management System, it's wireless, waterproof** and concealable. Each Pod still lets you trade multiple daily injections for up to 3 days (72 hours) of continuous insulin. The Pod can be worn almost anywhere you'd inject yourself or give an injection, allowing you to simplify your type 1 diabetes care and live your life without multiple daily injections.
* Dexcom G6 App is needed to control the G6 CGM
** The Pod has an IP28 rating for up to 25 feet for 60 minutes. The Controller is not waterproof.
Pod and dexcom shown without the necessary adhesive
OMNIPOD 5®
New and Improved Pod Therapy
Pod and dexcom shown without the necessary adhesive
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 SmartAdjustTM 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
With SmartAdjustTM technology, the Omnipod® 5 Automated Insulin Delivery System and Dexcom G6® CGM are in constant communication, enabling automatic insulin adjustments to help improve time in range.2 If you need to change settings or share data, the entire Omnipod® 5 System can be easily controlled through the Omnipod® 5 App.
How it Works
To learn more about how we are simplifying life with diabetes,visit us at Omnipod.com
Key Features
What's New
Smart AdjustTM Technology
Every 5 minutes, the Omnipod ® 5 System automatically increases, decreases, or pauses insulin delivery based on your customized settings — helping to protect against highs and lows, day and night.3
Activity Feature
Activity with a few finger taps. When using the Activity feature, the Omnipod® 5 System reduces insulin delivery when glucose typically goes low, like when excercising.
Smart Bolus Feature
The only automated insulin delivery (AID) system with a built-in bolus calculator that automatically incorporates your Dexcom G6® CGM data and trend, so you don't have to.
What's Still True
Multiple Daily injection-proof Design
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. The Controller is not waterproof.
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
1 Brown S. et al. Diabetes Care. 2021;44:1630-1640. Prospective pivotal trial in 240 participants with T1D aged 6 - 70 yrs [adults/adolescents (n= 128; aged 14-70 yrs) children (n=112; aged 6-13.9 yrs)]. Study included a 14-day standard therapy (ST) phase followed by a 3-month Omnipod® 5 hybrid closed-loop phase. Mean time >180 mg/dL in adults/adolescents and children, ST vs. 3-mo Omnipod® 5: 32.4% vs. 24.7%; 45.3% vs. 30.2%, P<0.0001, respectively. Median time <70 mg/dL in adults/adolescents and children, ST vs. 3-mo Omnipod 5: 2.0% vs. 1.1%, P<0.0001; 1.4% vs. 1.5%, P=0.8153, respectively. Results measured by CGM.
2 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.
3 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 hyperglycemic range (>180 mg/dL) as measured by CGM in adults/adolescents and children ST vs. 3-mo Omnipod® 5: 32.4% vs. 24.7%; 45.3% vs. 30.2%, P<0.0001, respectively. Mean time in hypoglycemic range (<70 mg/dL) as measured by CGM in adults/adolescents and children ST vs. 3-mo Omnipod® 5: 2.89% vs. 1.32%, P<0.0001; 2.21% vs. 1.78%, P 0.8153.
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 can 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: SmartAdjustTM technology should NOT be used by anyone under the age of 6 years old. SmartAdjustTM 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.
© 2022 Insulet Corporation. Omnipod, the Omnipod logo, DASH, the DASH logo, and SmartAdjust are trademarks or registered trademarks of Insulet Corporation in the United States of America and other various jurisdictions. All rights reserved. Dexcom and Dexcom 6 are registered trademarks of Dexcom, Inc and used with permission. All other trademarks are the property of their respective owners. The use of third-party trademarks does not constitute an endorsement or imply a relationship or other affiliation.
