Omnipod® 5 FAQs:
About Omnipod 5 System and Controller

The Omnipod 5 System is the first tubeless, automated insulin delivery system integrated with the Dexcom G6 and G7 Sensor, approved in Canada for use in people with type 1 diabetes, aged 2 and above. 

The Omnipod 5 System works with the Dexcom G6 and G7 Sensor to continuously adapt and automatically deliver insulin according to the user's personal needs.

The Omnipod 5 System is the first tubeless automated insulin delivery system integrated with the Dexcom G6 and G7 Sensor to manage glucose levels with no multiple daily injections and no routine fingersticks*.

Omnipod 5 consists of the tubeless and waterproof† Omnipod 5 Pod, the Omnipod 5 Controller and integrates with the Dexcom G6 and G7 Sensor.

The Pod is enhanced with SmartAdjust™ technology to automate insulin delivery using a customizable glucose target to simplify life with diabetes.

The Omnipod 5 SmartBolus calculator is used to calculate a recommended bolus dose. A unique feature of the SmartBolus calculator is that it adjusts the bolus based on the sensor value and trend as opposed to the user having to adjust the bolus manually. The SmartBolus Calculator will recommend more insulin when sensor values are trending up and less insulin when sensor values are trending down.

The Omnipod 5 System is intended for the management of type 1 diabetes mellitus in persons 2 years of age and older.

No, the Omnipod 5 System will require a dedicated Controller, which will be included in the Starter Kit. We do not currently have any details to share on smartphone compatibility.

The Omnipod 5 System works with the Dexcom G6 and G7 Sensor to continuously adapt and automatically deliver insulin according to the user's personal needs.

The Omnipod DASH System is not integrated with the Dexcom Sensor and is not capable of automated insulin delivery, but rather delivers insulin based on the user's programmed basal rates. The Omnipod 5 System is an automated insulin delivery system.

We currently do not have plans to discontinue the Omnipod System or the Omnipod DASH System. Any changes to product availability will be communicated well in advance.

The Omnipod 5 System will require a dedicated Controller, which will be included in the Starter Kit. It cannot be used with a smartphone and no details are currently available on when smartphone compatibility will be available.

No, the Omnipod System and Omnipod DASH Pods and PDM are not compatible with the Omnipod 5 System. The Omnipod 5 Pod includes an algorithm for automated insulin delivery and the Controller software is specific to the new Pod.

The Omnipod 5 Automated Insulin Delivery System uses its own Controller and Pods.

The Omnipod 5 Automated Insulin Delivery System is indicated for people with type 1 diabetes, ages 2 years and older, and is not indicated for use in pregnancy. Therefore, any decision to use the system during pregnancy should be discussed with your healthcare provider.

The Omnipod 5 Automated Insulin Delivery System is intended for the management of type 1 diabetes mellitus in persons 2 years of age and greater. The use of the Omnipod 5 System in a condition other than type 1 diabetes would be considered off-label. Please consult your healthcare provider for treatment options for your condition.

The Omnipod 5 System is not approved for people living with type 2 diabetes in Canada.

The Omnipod 5 System will be available at launch in English and French.

Unlike DIY looping systems, the Omnipod 5 System, which is an automated insulin delivery system, has undergone safety and efficacy testing and has received Health Canada approval.

Do-it-yourself (DIY) hybrid-closed-loop systems, such as Loop and OpenAPS, are not cleared by Health Canada or other Regulatory authorities and are not supported by Insulet. DIY systems are built by individuals using a smartphone, continuous glucose monitor, communication bridge and specific insulin pumps to automate insulin delivery. DIY systems are built using open-source software code and instructions are provided by patient-led groups within the diabetes community.

Omnipod 5 is a hybrid closed-loop system, which automatically adjusts basal insulin with the user manually delivering bolus insulin to cover meals.

AID stands for Automated Insulin Delivery and refers to a system that is able to automatically adjust insulin delivery based on glucose readings from an integrated glucose sensor.

Within this category there are HCLs, which stand for Hybrid Closed Loop systems. These automatically adjust basal insulin based on glucose readings from an integrated glucose sensor, with the user manually delivering bolus insulin to cover meals.

Currently, all available AID systems on the market are HCLs, which mean that there is still a need to manually deliver bolus insulin at mealtimes. Therefore, you may hear these 2 terms used interchangeably.

To benefit from automated insulin delivery, the Omnipod 5 System is currently compatible with the Dexcom G6 and G7 Sensors.

We are continuing to develop our offering for integration with a wider range of sensors. However, we are unable to comment further with any specific details at this time.

When using the Omnipod 5 System with a compatible Dexcom Sensor, the sensor activation and deactivation, sensor settings, notifications, and alarms are all controlled by the Dexcom G6 or G7 app on a compatible on a smartphone. Glucose values will be visible within the Omnipod 5 App on the provided Controller and the Dexcom app. Apps associated with the Dexcom Sensor will still be able to be used

The Dexcom G6 and G7 Sensor is needed to use the Omnipod 5 System in Automated Mode and to benefit from automated insulin delivery. Speak to your healthcare provider to find out if the Dexcom Sensor is suitable for you.

The Omnipod 5 Pod will provide automated insulin delivery for up to 3 days (up to 72 hours).

Yes, the Omnipod 5 Pod is the same size as the previous Omnipod System and Omnipod DASH Pods.

The Omnipod 5 Pod is waterproof and has an IP28 rating for up 7.6 metres (up to 25 feet) for 60 minutes. The Omnipod 5 Controller is not waterproof. The Dexcom G6 Sensor and Transmitter are water resistant and may be submerged under 8 feet (2.4 metres) of water for up to 24 hours without failure when properly installed. The Dexcom G7 Sensor is waterproof and may be submerged under 8 feet (2.4 metres) of water for up to 24 hours without failure when properly installed.

After 20 minutes of the Pod not receiving sensor glucose values, the Omnipod 5 System will move into a state of Automated Mode called Automated: Limited. The Omnipod 5 App will display 'Limited' on the Home Screen.

With Automated Insulin Delivery (AID) systems, to maximize time in automated mode, the Pod and sensor should be placed in 'line of sight', so that the sensor readings are communicated to the pump/Pod. ‘Line of sight’ for Omnipod 5 means that the Pod and Sensor are worn on the same side of the body such that the two devices can ‘see’ one another without the body blocking their communication. Refer to the Omnipod 5 User Guide for further information.

If your sensor glucose values do not match your symptoms, ALWAYS check your blood glucose using a BG meter, consider treatment and/or sensor calibration if necessary. You may need to replace your sensor. ALWAYS switch to Manual Mode if you feel you are receiving inaccurate sensor glucose values.

If you are having symptoms that are not consistent with your blood glucose readings and you have followed all instructions described in this User Guide, contact your healthcare provider, and the sensor manufacturer for assistance if required.

Please take note of the following information, adapted from the Omnipod 5 System Technical User Guide, that may lead to sensor inaccuracies:

• Do not use the sensor if the packaging appears to be damaged, already opened, or past the expiration date.
• Check that the sensor codes match on the sensor pack and sensor applicator before using. Different sensor codes will result in incorrect sensor glucose values.
• Adhere to the glucose sensor’s approved site placements.
• Make sure your sensor information entered in the Omnipod 5 App is matching the one you are wearing.

Please refer to the Sensor Manufacturer for guidance on sensor replacement. Always consult with your healthcare provider regarding any changes in your treatment.

No, basal insulin dosing is only available in increments of 0.05 units/hour.

The Omnipod 5 Pod has the same insulin reservoir size as the current Omnipod System and Omnipod DASH Pods which holds up to 200 units of compatible U-100 insulin.

The Omnipod 5 System is indicated for use with NovoLog®/NovoRapid®, Humalog® /Liprolog®, Trurapi®/Truvelog®/Insulin aspart Sanofi®, Kirsty®, and Admelog/Insulin lispro Sanofi U-100 insulin.

Insulet evaluated the impacts of adjusting insulin every minute compared to every five minutes, and determined there were no significant advantages to adjusting insulin more frequently than every 5 minutes.

The Omnipod 5 Controller sends and receives information from the Pod using Bluetooth® wireless technology and therefore cellular connectivity does not impact insulin delivery.

If the battery runs out on the Omnipod 5 Controller, the user will continue to receive insulin as it was programmed prior to the battery running out. For example, if the user were in Automated Mode when the Controller battery ran out, then they will remain in Automated Mode as long as the Pod continues to receive CGM values. If they were in Manual Mode, they will receive basal insulin based on the programmed basal rates. The user will not be able to bolus if the Controller has run out of battery.

When using the Dexcom Sensor with Omnipod 5 the Dexcom app on a compatible smartphone is required to undertake all the normal activities associated with the Dexcom Sensor including receiving Dexcom alerts and alarms. The Dexcom receiver cannot be used with Omnipod 5. The Omnipod Controller works independently of the Dexcom app and does not link at all with the Dexcom Sensor nor the Dexcom app.

The Omnipod 5 SmartBolus calculator is used to calculate a recommended bolus dose. A unique feature of the SmartBolus calculator is that it adjusts the bolus based on sensor value and trend (when a user chooses to use a sensor) as opposed to the user having to adjust the bolus manually. The SmartBolus calculator will recommend more insulin when sensor values are trending up and less insulin when sensor values are trending down.

Extended bolus cannot be used in automated mode. Extended boluses are available in Manual mode. Insulet conducted feasibility studies using high fat meals on Omnipod 5 Automated mode vs Manual mode with extended bolus and observed no clinically significant difference in glucose levels.

With the Omnipod 5 System, bolusing for meals and snacks helps the system adapt the total daily insulin (TDI) that SmartAdjustTM technology (the automated insulin delivery algorithm) uses. If carbs are consumed and no bolus is delivered, SmartAdjust responds to the rising glucose trend by delivering insulin microboluses up to 4 times the user's adaptive basal rate every 5 minutes. However, it may take longer to bring glucose down.

Information is passed from the Pod to the Omnipod 5 Controller and vice versa i.e., from the Controller to the Pod via Bluetooth®.

Connectivity to cellular data or Wi-Fi is important when using the Omnipod 5 System. Staying connected will allow you to be notified of important updates as well as allow seamless auto uploading of your data to Insulet’s secure cloud. The provided Omnipod 5 Controller is equipped with a SIM card that allows you to connect to cellular data at no cost to you.

• All updates on the Controller that are considered optional require a Wi-Fi connection.
• If you have an immediate bolus, software updates will be delayed until the bolus is complete.
• Connect ONLY to trusted Wi-Fi networks with your Controller.
• AVOID connecting to public Wi-Fi networks (such as those found in airports, coffee shops etc as these networks are not secure and could result in exposing your Controller to malware.
• DO NOT connect to public Wi-Fi networks during first time setup of your Omnipod 5 system.

If your question is about the Controller, the Pod or the algorithm – please call Omnipod Customer Care at 1-855-POD-INFO (1-855-763-4636).
If your question is about the Dexcom Sensor - please call Dexcom Care Patient Support Services at 1-844-832-1810. If you have any clinical questions regarding your health, please contact your healthcare provider.

If your question is about the Controller, the Pod or the algorithm – please call Omnipod Customer Care at 1-855-POD-INFO (1-855-763-4636).

If your question is about the Dexcom Sensor - please call Dexcom Care Patient Support Services Technical at 1-844-832-1810.

If you have any clinical questions regarding your health, please contact your healthcare provider.

The switch from one system to another will require a hardware change. The Omnipod 5 System uses the specific Omnipod 5 Controller with a pre-loaded app and specific Pods to enable automated insulin delivery. The new Omnipod 5 Pods and the Controller will be included in your Starter Kit. Existing Omnipod System or Omnipod DASH Pods are not compatible with the new Omnipod 5 System. Training on the Omnipod 5 will be required when moving from Omnipod DASH or Omnipod System (Eros).