Omnipod® 5 Automated Insulin Delivery System _{Now CE marked!}

^{1. Dexcom G6 CGM System sold separately.}

^{2. The Omnipod®5 System must be used with the Dexcom G6 app and is not compatible with the Dexcom G6 receiver. Dexcom compatible smart devices sold separately: www.dexcom.com/ compatibility}

^{3. Brown S. et al. Multicenter trial of a tubeless, on-body automated insulin delivery system with customizable glycemic targets in pediatric and adult participants with type 1 diabetes. Diabetes Care. 2021;44(7):1630-1640. Prospective pivotal trial in 240 participants with T1D aged 6-70yrs [adults/adolescents (n=128; aged 14-70yrs0 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 s(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. Median time in hypoglycemic range (<70 mg/dL) as measured by CGM 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. Mean time in range (70-180 mg/dL) during 110 mg/dL Target BG in adults/adolescents (n=121) =75.6%. Mean time in range (70-180 mg/dL; 12AM to <6Am) in adults/adolescents and children as measured by CGM during St vs. 3-mo Omnipod®5: 64.3% vs. 78.1%; 55.3% vs. 78.1%, P<0.0001, respectively. Median time in hypoglycemic range in adults and adolescents (<70 mg/dL 12AM- <6AM) as measured by CGM: ST=2.07%, 3-mo Omnipod®5 =0.82%, P<0.0001. Comparison is a relative change. Mean time 70-180 mg/dL as measured by CGM in adults/adolescents and children, ST vs. 3-mo Omnipod®5: 64.7% vs. 73.9%; 52.5% vs. 68.0%, P<0.0001, respectively.}

^{4. Sherr JL et al. Safety and glycemic outcomes with a tubeless automated insulin delivery system in very young children with type 1 diabetes: a single-arm, multicenter clinical trial. Diabetes Care. 2022; doi: 10.2337/dc21-2359 [Online ahead of print]. 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 HbA1c: ST vs. Omnipod 5 use in very young children (2 - 5.9 yrs) 7.4% vs 6.9%, P<0.05.}

^{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 supervision of the user's healthcare professional. 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) 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.}