Omnipod® 5 FAQs:
Algorithm

The Omnipod 5 SmartAdjust™ technology algorithm ensures safe automated insulin delivery when sensor glucose readings are inaccurate in a few ways:

1. The algorithm has safety constraints to ensure safe insulin delivery when it receives inaccurate glucose values that are out of the norm (“noisy” values).
2. The algorithm delivers insulin based on current glucose values and a 60-minute prediction, therefore, minimizing the impact of one-off sensor inaccuracies.
3. The algorithm has safety criteria that limit the amount of insulin delivered regardless of sensor readings. If the safety criteria are met, the system will put the system in Automated Mode: Limited. During Automated Mode: Limited, the system will deliver insulin that will not be higher than the Basal Program that would be active during Manual Mode.
4. Insulet ensures that all glucose sensors used with the Omnipod 5 System meet performance standards. The Omnipod 5 System is only compatible with sensors that are cleared/approved with local regulators.
5. The performance of the Omnipod 5 System has been validated in clinical trials to ensure the product is safe and effective.

All sensors integrated with the Omnipod 5 System must be both regulatory cleared/approved and meet internal sensor specifications.

The Omnipod 5 SmartBolus calculator was designed and validated in multiple clinical trials to suggest and deliver safe insulin for boluses.

If an inaccurate sensor value is used in the SmartBolus calculator by tapping “Use Sensor”, the algorithm evaluates IOB and sensor trend to suggest bolus amounts that are not too reactive to potential noise in sensor values.

A compression low or pressure induced sensor attenuation (PISA) happens when a user’s glucose sensor is compressed on their body, such as when sleeping on the side of the sensor and gives the user a temporary false reading of a low glucose. In these situations, automated insulin delivery will likely decrease or pause during the compression low event and resume once glucose values increase towards your true glucose values. If sensor values increase rapidly after recovery of a PISA event, further built-in safety measures prevent too much insulin delivery.

The Omnipod 5 SmartAdjust™ technology algorithm has built-in safety measures to prevent insulin being paused for too long. In the case of a long duration compression low, the system will likely enter Automated Mode:Limited.

Please contact the Glucose Sensor Manufacturer on for guidance on how to avoid compression lows.

At times, the Omnipod 5 System Pod and sensor may lose communication while a user is in Automated Mode. When this occurs, SmartAdjust™ technology can no longer adjust a user’s automated insulin delivery based on glucose. After 20 minutes of the Pod not receiving sensor glucose values, the system will enter a state of automated insulin delivery called Automated Mode: Limited. During Automated Mode: Limited, the system will deliver no more than the programmed basal rates.

During this state, the Omnipod 5 App will display ‘Limited’ on the home screen. The user’s system will remain in Automated Mode: Limited until sensor communication is restored.

After one hour of missing sensor glucose data, the users will be notified to troubleshoot via the Missing Sensor Glucose advisory alarm. The user will remain in Automated Mode: Limited and will continue to receive no more than the programmed basal rates until sensor communication is restored.

The Omnipod 5 Pod is enhanced with a control algorithm called SmartAdjust™ technology. Every 5 minutes, SmartAdjust™ technology receives a sensor 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 & for corrections.

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 corrections.

During the first Pod wear, since there is insufficient insulin delivery history available, the system will estimate the total daily insulin based on the user-entered active basal program. The starting rate will be adjusted upwards or downwards based on the current and predicted glucose and trend.

During this initial period, automated insulin delivery is reduced for safety.

After a minimum of 48 hours of wear and a Pod change, the system starts adapting based on the total daily insulin administered by the Pod (basal + bolus insulin).

Adaptivity updates with each Pod change.

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.

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 Program 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 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.

No. The Omnipod 5 System uses Pods that deliver insulin in 0.05 unit increments. It's important to remember that basal insulin delivery during Automated Mode varies with increases, decreases, and pauses to basal insulin delivery.

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.

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. 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. When SmartAdjust™ predicts high glucose values, it will deliver a microbolus up to 4 times the user's adaptive basal rate 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.

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.