*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.
1. Study in 80 people with T1D aged 2 5.9 years involving 2 weeks standard diabetes therapy followed by 3 months Omnipod 5 use in Automated Mode. Average time in Target Glucose range (from CGM) for standard therapy vs Omnipod 5 = 57.2% vs. 68.1%. Average time in Target Glucose range (6AM 12AM) from CGM in standard therapy vs Omnipod 5 = 58.2% vs. 64.3%. Average time in Tar get Glucose range (12AM 6AM) from CGM in standard therapy vs. Omnipod 5 = 60.6% vs 82.4%. Average overnight time (12AM 6AM) with high blood glucose in adults/adol escents and children for standard therapy vs. Omnipod 5 = 32.1% vs. 20.7%; 42.2% vs. 20.7%. Average day time (6AM 12AM) with high blood glucose in adults/adolescents and children for standard therapy vs. Omnip od 5 = 32.6% vs. 26.1%; 46.4% vs. 33.4%. Median overnight time (12AM 6AM) with low blood glucose in adults/adolescents and children for standard therapy vs. Omnipod 5 = 2.07% vs. 0.82%; 0.78% vs. 0.78%. Media n d ay time (6AM 12AM) with low blood glucose in adults/adolescents and children for standard therapy vs. Omnipod 5 = 1.91% vs. 1.08%; 1.17% vs. 1.62%. Average A1c in standard therapy vs. Omnipod 5 = 7.4% vs. 6.9%. Sherr JL, et al. Diabetes Care (2022).
2. Study in 240 people with T1D aged 6 70 years involving 2 weeks standard diabetes therapy followed by 3 months Omnipod 5 use in Automated Mode. Average time in Target Glucose range (from CGM) for standard therapy vs Omnipod 5 in adults/adolescents and children = 64.7% vs. 73.9%; 52.5% vs. 68.0%. Average day time (6AM 12AM) in Targe t Glucose range (from CGM) in adults/adolescents and children for standard therapy vs Omnipod 5 = 64.8% vs. 72.5%; 51.5% vs. 64.6%. Average overnight (12AM 6AM) in Target Glucose range (from CGM) in adults/adole scents and children for standard therapy vs Omnipod 5 = 64.3% vs. 78.1%; 55.3% vs. 78.1%. Average time with high blood glucose overnight from CGM in standard therapy vs. Omnipod 5 = 38.4% vs. 16.9%. Average time wit h h igh blood during daytime from CGM in standard therapy vs. Omnipod 5 = 39.7% vs. 33.7%. Average time with low blood glucose overnight from CGM in standard therapy vs. Omnipod 5 = 3.41% vs. 2.13%. Ave rage time with low blood glucose during daytime from CGM in standard therapy vs. Omnipod 5 = 3.44% vs. 2.57%. Average A1c in adults/adolescents and children, standard therapy vs. Omnipod 5 = 7.16% vs 6.78%; 7.67% vs 6.99%. Brown et al. Diabetes Care (2021).
Risk Statement
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: NovoRapid®, Humalog®, and Admelog®.The Omnipod 5 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 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 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.
