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Objective: Medtronic Mio™ 30 infusion set (M30IS) is a single-use consumable for pump users with pre-loaded inserter, utilizing a 30° insertion angle, and labeled for 3-day use. The M30IS wear duration is impacted by initial local trauma caused by insertion & cannula and sustained inflammation mostly by insulin infusion (especially insulin aggregates and other impurities in the infusate) , with the latter being predominant. Recently, a 7-day Medtronic Extended Infusion Set (MEIS) based on 3-day Mio™ Advance IS with a 90° soft cannula was developed and commercialized in Europe, by improving insulin formulation stability in the fluid path. This study is focused on applying the extended wear (EW) technology from MEIS to the M30IS to develop an EW set with angled cannula (the EM30IS) . Method: This is a cross over study of M30IS and EM30IS on drug-induced Type 1 diabetic Yucatan pigs. Each animal wore both sets multiple times with one each time on the abdomen that was continuously infused with Novolog™ subcutaneously via a pump for 1-week or until failure. Blood glucose were measured 5 times/day. Physical examination and serum panel tests were conducted for safety evaluation. Result: Fourteen wears were completed for each device. No significant safety concern was identified. Compared to the 90° cannula sets tested on the same model having occlusion alarm rate of 0∼20% for MEIS and ∼40% for 3-day sets at 7 days, no occlusion alarm was detected in either M30IS or EM30IS. Survival rate of EM30IS (86%, similar to MEIS) trended higher than that of M30IS (71%) . Average total daily dose of insulin increased with time for M30IS (Day 1: 14.4 U, Day 6: 18.1U) , whereas remained nearly unchanged for EM30IS (Day 1: 14.9 U, Day 6: 15.6 U) . Conclusion: The data indicated that the EM30IS is safe and efficacious on the diabetic porcine model for subcutaneous insulin infusion for 7 days. The EW technology is equally safe and effective on extending the wear duration of M30IS. The EM30IS is moving to the next phase of product development. Disclosure G.Zhang: Employee; Medtronic. E.Anselmo: Employee; Medtronic. J.L.Ortigoza: Employee; Medtronic. S.Chattaraj: Employee; Medtronic. |
