Medtronic gets FDA approval to begin diabetes device study

1 November 2011 (Last Updated November 1st, 2011 18:30)

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.

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.