Frequently Asked Questions (FAQs)

 

Please find the answers to the frequently asked questions below.

In case you have further questions, please contact us at digital-developer@novonordisk.com

 

1. Why is Novo Nordisk allowing you to provide your users access to insulin dose data from NovoPen® 6 and NovoPen Echo® Plus in your solution?

We believe that someone using a NovoPen® should be able to see their own data on the solutions they prefer, and we want to help everyone who is innovating, in order to improve the wellbeing of people living with diabetes.

2. Does Novo Nordisk automatically receive or track patient dose data from its smart insulin pens NovoPen® 6 and NovoPen Echo® Plus?

No. Novo Nordisk cannot see who is using its medicines or smart insulin pens unless otherwise formally agreed, for example in a clinical trial or via a data sharing agreement and consent from users. Moreover, it is not technically possible for NovoPen® 6 or NovoPen Echo® Plus to directly transfer data to Novo Nordisk. 

3. How and when might Novo Nordisk receive patient data from NovoPen® 6 and NovoPen Echo® Plus smart insulin pens?

When a data sharing agreement between Novo Nordisk and a developer is in place, Novo Nordisk may be able to access limited, pseudonymised data when a patient connects their NovoPen® 6 or NovoPen Echo® Plus to the developers solution, such as an app, if the patient also provides consent. In these instances, Novo Nordisk does not collect the data directly, rather, the data is gathered via the developers’ apps and solutions and shared with Novo Nordisk, again given patient consent. Importantly, anyone who does not consent to sharing their data with Novo Nordisk should still receive full access to the functionality of the developers’ apps and solutions and their NovoPen® 6 or NovoPen Echo® Plus. 

4. Why is Novo Nordisk interested in seeing data from people using smart insulin pens?

We believe that digital health solutions can not only make life a bit easier for people with diabetes, it may also help them achieve better health outcomes. We want to use real world data to show the positive impact these solutions can have on people’s lives, in order to advocate for access to digital solutions, and to encourage the industry to innovate. Beyond proving efficacy, we also believe that understanding how people use our medicines will help us create better products and solutions in the future.

5. Can people decline to share their data with Novo Nordisk and still have full functionality of their pens?

Yes. Anyone who does not consent to share their data with Novo Nordisk will still receive full access to the functionality of their NovoPen® 6 or NovoPen Echo® Plus. It is not possible for Novo Nordisk to gather data from apps or devices that connect with the pens unless the developer shares data with Novo Nordisk under the terms of a data sharing agreement. Furthermore, the end-users will need to provide their consent for any personal data to be shared with Novo Nordisk. Importantly, anyone who does not consent to share their data with Novo Nordisk should still receive full access to the functionality of the developers’ solutions and their NovoPen® 6 or NovoPen Echo® Plus (Refer to question, ‘How and when might Novo Nordisk receive patient data from NovoPen® 6 and NovoPen Echo® Plus smart insulin pens’). 

6. Will every app or device developer be granted access to connect with NovoPen® 6 or NovoPen Echo® Plus?

Any developer wishing for their app or device to connect with or ‘read’ data from Novo Nordisk smart insulin pens can register to get access. Developers must acknowledge that they have read and will comply with agreement for use of the specifications. Novo Nordisk will not audit, check or scrutinise solutions from a quality, legal or regulatory view. If, however, it is obvious that a solution could put patient safety at risk, the developer will not be permitted to receive documentation enabling them to develop a connection with NovoPen® 6 & NovoPen Echo® Plus. Some developers may also be asked to sign a data sharing agreement. Please visit the ‘Requirement’ section of this site for guidance and further information. 

7. Can Novo Nordisk automatically see data from the users of my solution?

No. Should you decide to visualise data from NovoPen® 6 or NovoPen Echo® Plus on your app or device, it is important to remember that NovoPen® 6 and NovoPen Echo® Plus do not connect with any Novo Nordisk data systems. It is therefore impossible for Novo Nordisk to collect any data from your app or device without a data-sharing agreement and procedures in place. 

8. What promotional, financial or technical support will Novo Nordisk offer me?

Novo Nordisk is not offering promotional or financial support to app or device solution developers. We are, however, making it possible for your app, device or system to read the data recorded by our smart insulin pens, and in doing so, we hope your users will gain even more value from your solution. After registering and logging on once you have been granted access, you can find an additional FAQ which will answer common technical questions on the developer site. 

9. Do patients need to consent in order for my app to read or connect to data from their smart insulin pen?

As part of the registration process, all developers should ensure they understand and abide by applicable data protection regulations, for example, GDPR. In most cases, local data protection regulations will require that an app or service request user consent in order to process their personal data.

10. Which companies already connect to Novo Nordisk’s smart insulin pens?

There are five partners that integrate a number of their solutions with Novo Nordisk smart insulin pens. These are: Abbott, Dexcom, Glooko, Medtronic and Roche. Partners have certain rights to promote the integration of their products with Novo Nordisk smart insulin pens and as part of these larger agreements. In comparison, through this portal, you as a registered app and device developer would receive access to read and/or share data from NovoPen® 6 and NovoPen Echo® Plus. Additional promotional and/or co-promotional activities are not possible.

At Novo Nordisk, we are excited every time a new developer registers for access to NovoPen® 6 and NovoPen Echo® Plus smart pen data, and we are optimistic that these solutions will provide great value for patients with many different needs. Novo Nordisk does not disclose the names or details of solutions that are registered through this portal, nor do we promote the availability of these solutions. We require that all registered developers respect our requirements when describing how their solution connects with Novo Nordisk smart pens. For more detail, please refer to the agreement for use of the specifications under the "requirements" tab.

11. How can I publicise or share the news that my app or device works with Novo Nordisk smart insulin pens?

You can share that your app or device can connect with NovoPen on your company website, in the app stores and as a push notification via your app or device to users already using your solution. You cannot make any public statement, written or oral, referring to Novo Nordisk’s devices or drugs without Novo Nordisk’s prior review and written approval. For more details on the specific language you are allowed to use, please refer to the agreement for use of the specifications under the "requirements" tab.

12. Is it ok with Novo Nordisk if I also connect my app with smart insulin pens from other manufacturers?

Yes. We must all work collaboratively in order to help people get the most from their disease management.

13. How do I report if something goes wrong or one of the users of my solution experiences an issue or side effect in relation to the use of a Novo Nordisk product?

If a person treated with a Novo Nordisk product reports an issue or side effect experienced in relation to the use of the product, you are obliged to ensure that the issue or side effect is reported to us. You can do that and get more information by using the following links:
 

Reporting an issue with a Novo Nordisk product:

https://www.novonordisk.com/patient-support/report-a-product-issue.html

Reporting a side effect to a Novo Nordisk product:

https://www.novonordisk.com/patient-support/report-a-side-effect.html

14. What Novo Nordisk medicines are supported by Novo Nordisk smart insulin pens?

NovoPen® 6 and NovoPen Echo® Plus accept Novo Nordisk insulins available in 3ml Penfill® cartridges. The medicines available vary by country and are subject to change. 

15. What is a durable pen and what is a pre-filled pen?

A durable pen has removable cartridges and can be reused by switching the cartridge. A pre-filled pen is thrown away once the insulin is used. 

16. Does Novo Nordisk have a solution for “pre-filled” insulin pens such as FlexTouch®?

Novo Nordisk expects to deliver a Bluetooth add-on solution for select insulins in FlexTouch® pens in selected markets. At this time Novo Nordisk is not providing the opportunity for developers to integrate with that device.

17. Do Novo Nordisk smart insulin pens work with medicines not produced by Novo Nordisk?

No. Novo Nordisk smart insulin pens are designed with an aim to offer the highest quality and precision for Novo Nordisk medicines; they do not work with medicines from other companies.