Omnipod® 5 FAQs:
SmartAdjust™ Technology

The Omnipod® 5 Pod is enhanced with a control algorithm called SmartAdjust™ technology. Every 5 minutes, SmartAdjust™ technology receives CGM value and trend data and it takes this information and predicts where glucose will be 60 minutes into the future. It then increases, decreases, or pauses automated insulin using the user's customized target.

^{Note: As with all Hybrid Closed-Loop systems, you will still need to bolus for meals and for correction.}

Target Glucose is the only adjustable setting that directly impacts automated insulin delivery. Target glucose is used for both the target for automated insulin delivery as well as the target for correction bolus calculations within the SmartBolus calculator. SmartBolus calculator settings can also be adjusted, and include the Target glucose & Correct Above values, Insulin to Carb ratio, Correction Factor, Duration of Insulin action, and Reverse Correction. Note that adjusting Basal Program segments after system initiation ONLY impacts Manual Mode basal insulin delivery.

In Automated Mode, Omnipod 5 SmartAdjust Technology predicts where your glucose will be 60 minutes into the future. SmartAdjust technology uses this information, along with your current sensor glucose value and trend, to automatically adjust insulin delivery every 5 minutes. The System’s goal is to help you bring your glucose to your defined Target Glucose. In Manual Mode, the System delivers insulin using a programmed basal rate. With the Omnipod 5 System, the user has the choice of whether they want to use Automated Mode or Manual Mode.

^{Note: As with all Hybrid Closed-Loop systems, you will still need to bolus for meals and for correction.}

In Automated Mode, automated insulin delivery adapts to your changing needs as you wear the System. As you use the Omnipod 5 System and gather insulin delivery history, SmartAdjust technology will automatically update your next Pod with information from your last few Pods about your recent total daily insulin (TDI). Your baseline Adaptive Basal Rate is based on how much total daily insulin you have needed over the past few weeks. With each Pod change, SmartAdjust technology uses this updated TDI to set a new Adaptive Basal Rate for you. (See Chapter on Pod Adaptivity in the Omnipod 5 Technical User Guide for more information).

^{Note: As with all Hybrid Closed-Loop systems, you will still need to bolus for meals and for correction.}

The Initial Adaptive Basal rate in the first Pod is calculated based on user selected basal rate profiles and then updates over time by tracking insulin delivered by the system. With each new Pod the system updates Total Daily Insulin (TDI) based on what was delivered for physiological needs. In a clinical study, improvement in time in range was achieved within a few Pod changes and remained stable thereafter.

At times, your Pod and Sensor may lose communication while you are in Automated Mode.

When this occurs, SmartAdjust technology can no longer adjust your automated insulin delivery based on glucose because the Pod is not receiving updated glucose information from the Sensor.

After 20 minutes of the Pod not receiving sensor glucose values, you move into a state of Automated Mode called Automated: Limited. The Omnipod 5 App will display “Limited” on the Home screen. Your System will remain in Automated: Limited until Sensor communication is restored or the Sensor warmup period ends

When the System enters Automated: Limited state, SmartAdjust technology bases its insulin delivery on the following:

• It looks at your basal rate in Manual Mode at this time of day and your adaptive basal rate for this Pod, and chooses the lower of the two values every 5 minutes. In this way, SmartAdjust technology never gives more than the Basal Programme that would be active during Manual Mode.
• If SmartAdjust technology had paused your insulin before the Pod lost connection with your Sensor, it will continue to pause insulin up to 40 minutes for a total of 1 hour paused. After 1 hour of no sensor glucose information, it will resume your insulin at your adaptive or manual basal rates, whichever is lower.
• Without sensor glucose information, the rate delivered in Automated: Limited will not adjust up or down for current or predicted glucose.

At times, your Pod and Sensor may lose communication while you are in Automated Mode.

When this occurs, SmartAdjust technology can no longer adjust your automated insulin delivery based on glucose because the Pod is not receiving updated glucose information from the Sensor.

After 20 minutes of the Pod not receiving sensor glucose values, you move into a state of Automated Mode called Automated: Limited. The Omnipod 5 App will display “Limited” on the Home screen. Your System will remain in Automated: Limited until Sensor communication is restored or the Sensor warmup period ends

When the System enters Automated: Limited state, SmartAdjust technology bases its insulin delivery on the following:

• It looks at your basal rate in Manual Mode at this time of day and your adaptive basal rate for this Pod, and chooses the lower of the two values every 5 minutes. In this way, SmartAdjust technology never gives more than the Basal Programme that would be active during Manual Mode.
• If SmartAdjust technology had paused your insulin before the Pod lost connection with your Sensor, it will continue to pause insulin up to 40 minutes for a total of 1 hour paused. After 1 hour of no sensor glucose information, it will resume your insulin at your adaptive or manual basal rates, whichever is lower.
• Without sensor glucose information, the rate delivered in Automated: Limited will not adjust up or down for current or predicted glucose.

The Omnipod® 5 Pod is enhanced with a control algorithm called SmartAdjust™ technology. Instead of remembering routines, the Omnipod 5 System continually monitors and adjusts insulin deliver as needed. Every 5 minutes, SmartAdjust™ technology receives CGM value and trend data and it takes this information and predicts where glucose will be 60 minutes into the future. It then increases, decreases, or pauses automated insulin using the user's customized target.

^{Note: As with all Hybrid Closed-Loop systems, you will still need to bolus for meals and for correction.}

The Omnipod 5 System is a Hybrid-Closed Loop System. Therefore, it is still important to bolus before meals that contain carbohydrates. You should also bolus to correct high glucose levels. Follow the advice of your healthcare provider regarding bolus dosing and timing. 

The Omnipod 5 System uses pods that deliver insulin in 0.05 unit increments. It is possible to programme a minimum hourly basal rate setting of 0.00 units per hour basal rate in Manual mode. When the Omnipod 5 System is in Automated mode, it may also pause the Adaptive Basal Rate as needed.

Users of the Omnipod 5 System can set target glucose values ranging from 6.1, 6.7, 7.2, 7.8 to 8.3 mmol/L (110, 120, 130, 140, 150 mg/dL). Users can choose to set up to 8 different glucose target segments per day.  

The SmartAdjust Technology is able to respond to high glucose levels by increasing insulin to bring glucose down towards the Target Glucose. Omnipod 5 may deliver a microbolus of insulin every 5 minutes with the aim to reach the user's customised Target Glucose Setting that ranges from 6.1 to 8.3 mmol/L (110 to 150 mg/dL).

The Omnipod 5 System is approved for use in people with type 1 diabetes aged 2 years and older. The Omnipod 5 System and algorithm are the same for users of all ages.