The single arm study will enroll up to 150 subjects, aged 18 to 80, with type 1 diabetes on insulin pump therapy
Irish medical technology firm Medtronic has secured investigational approval from the US Food and Drug Administration (FDA) to start a pivotal trial for the assessment of new extended wear infusion set.
The trial is being carried out for the collection of clinical data to support the use of the extended wear infusion set for up to seven days, which is over twice the length of time that any infusion set can currently be used.
Single arm study with an extended wear infusion set
Medtronic will recruit up to 150 subjects, aged between 18 and 80, with type 1 diabetes on insulin pump therapy in the multi-centre, non-randomised and prospective single arm study
Infusion sets enable people on insulin pump therapy to deliver insulin under the skin for the maintenance of healthy blood glucose levels.
The new infusion sets, which use an advanced technology developed in collaboration with ConvaTec’s Unomedical subsidiary, are designed to extend patient wear time and maintain insulin stability.
An extended wear infusion set is believed to address a crucial unmet need in insulin pump therapy by reducing the time and effort currently spent on changing infusion sets.
The new infusion set may enable coordination of changing of the infusion set and sensor at the same time, when used with Medtronic insulin pump systems that include 7-day continuous glucose monitors.
MiniMed 670G system users will wear each infusion set for up to seven days in the trial.
The commencement of the trial follows the company’s receipt of an investigational device exemption (IDE) approval from the FDA.
University of Colorado’s Barbara Davis Center aduly diabetes division director and medicine and pediatrics professor Dr Satish Garg said: “There have been significant advances made in the three-plus decades with insulin pumps and continuous glucose monitoring (CGM). However, we are still stuck with having patients change the insulin delivery sets every 2-3 days whereas most CGMs are now used longer.
“It is time for an infusion set to extend wear to a week and beyond. This is long overdue and will likely improve quality of life for patients on insulin pumps, and many more patients may accept insulin pump as an option.”
In June this year, Medtronic commenced the pivotal study of its next-generation Guardian continuous glucose monitoring (CGM) sensor.