InsuLine Applies to FDA for InsuPatch
InsuLine Medical has submitted an application to the FDA for the approval of its InsuPatch™ device.
Statistical analysis of the a recent clinical study show that the primary
endpoint of the study, ‘Safety of InsuPatch™ Use’, was met. The safety of InsuPatch™,
together with the Medtronic Minimed pump, is not inferior to the safety of pump use alone,
with respect to the number of hypoglycemia events. This was achieved with a ‘p’ value of
p<0.0001 while the protocol required p<0.05. In this cross over study, 113 subjects
completed both test and control phases, while the protocol requirement was for 100
subjects. This result complements the efficacy study results which showed earlier that,
when using the InsuPatch™ product, there was an increase of 29.7% (median) in the
relative insulin levels in the blood during the first hour after the injection, as compared to
the blood insulin levels during the first hour after the injection without using the device.
This improvement was higher than the 10% improvement which was required by the FDA
efficacy trial protocol.