Medtronic has received investigational device exemption approval from the US Food and Drug Administration (FDA) to conduct a pivotal in-home study using its MiniMed Paradigm system.

The second -generation insulin pump is used to treat type 1diabetes and features low-glucose suspend automation.

The multicentre, randomised study is intended to evaluate the safety and efficacy of the low-glucose suspend feature.

A new continuous glucose sensor, Medtronic’s Enlite, will also be tested as part of the overall system.

The primary endpoint of the study is to demonstrate that home use of the low-glucose suspend feature is safe, and is not associated with glycaemic deterioration, as measured by a change in glycated haemoglobin.

The secondary endpoint is to show that home use of the low-glucose suspend feature is associated with a reduction in nocturnal hypoglycaemia when patients fail to respond.

How well do you really know your competitors?

Access the most comprehensive Company Profiles on the market, powered by GlobalData. Save hours of research. Gain competitive edge.

Company Profile – free sample

Thank you!

Your download email will arrive shortly

Not ready to buy yet? Download a free sample

We are confident about the unique quality of our Company Profiles. However, we want you to make the most beneficial decision for your business, so we offer a free sample that you can download by submitting the below form

By GlobalData
Visit our Privacy Policy for more information about our services, how we may use, process and share your personal data, including information of your rights in respect of your personal data and how you can unsubscribe from future marketing communications. Our services are intended for corporate subscribers and you warrant that the email address submitted is your corporate email address.