1: American Diabetes Association. 7. Diabetes technology: standards of medical care in diabetes - 2021. Diabetes Care.2021;43(suppl 1):S85-S99.
2. 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.
3. Sherr JL, et al. Prospective trial in 80 participants with T1D aged 2 - 5.9 yrs. Study included a 14-day standard therapy (ST) phase followed by a 3-month Omnipod 5 hybrid closed-loop (HCL) phase. Mean time >180 mg/dL in very young children (2 - 5.9yrs) as measured by CGM: ST = 39.4%, 3-mo Omnipod 5 = 29.5%, P<0.0001. Mean time <70 mg/dL in very young children (2-5.9 yrs) as measured by CGM: ST = 3.41%, 3-mo Omnipod 5 = 2.13%, P=0.0185. Results measured by CGM.
4: The Pod has an IP28 rating for up to 25 feet for 60 minutes. The Controller is not waterproof.
* Fingersticks required for diabetes treatment decisions if symptoms or expectations do not match readings.
†For a list of compatible smartphone devices, visit omnipod.com/compatibility
‡ In addition to administering and canceling boluses, Omnipod 5 users have full system functionality from a smartphone including initial system configuration, new Pod set up, insulin delivery settings adjustments, alerts & alarms acknowledgement, and more.
§ SmartAdjust™ technology uses a customizable Target Glucose between 110-150 mg/dL, adjustable in 10 mg/dL increments. Control-IQ™ uses a non-adjustable Target Glucose range of 112.5-160 mg/dL, with an option to use Sleep Activity with a range of 112.5-120 mg/dL. SmartGuard™ Auto Mode uses a non-adjustable target sensor glucose setting of 120 mg/dL.
Important Safety Information
The Omnipod 5 Automated Insulin Delivery System is indicated for use by individuals with type 1 diabetes mellitus in persons 2 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 2 years old. SmartAdjust technology should also NOT be used in people who require less than 5 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.
