Objective: Current real-time continuous glucose monitoring (CGM) sensors are approved for 7-14 days of wear, whereas insulin infusion sets are indicated for 2-3 days of wear. Development of a closed-loop control system with the same duration of wear for its CGM and insulin infusion consumables necessitates an infusion set with greater longevity. This study assessed the safety and performance of a newly designed Extended Wear Infusion Set (EWIS) for up to 7 days.
Method: A single-center feasibility study targeted the recruitment of 26 adult subjects (between 22 and 75 years of age) This was a 1-center, prospective, open label one arm study, with each subject being asked to wear 4 trial devices until the infusion set failed or 7-day use was reached.
Result: There were twenty-one participants of whom 20 completed the study, resulting in 82 insertions and 78 wear counts. At 7 days of wear, the overall failure rate for the EWIS was 19.5%, which was comparable to that after 3-day use for a 3-day infusion set (∼23%) (MiniMed™ Quick-set), as previously reported. (Patel et al. Diabetes Technol Ther. 2014; 16:15-19). Over time, EWIS use for 7 days did not significantly increase hyperglycemia (mean SG value Day 3: 150 ± 56 mg/dL; Day 6: 160 ± 50 mg/dL; target < 250 mg/dL) or total daily insulin requirements (TDI at Day 1: 41±17 U/Day; Day 3: 40±17 U/Day; Day 7: 43 ±20 U/Day) There were no events of infusion set blockage or diabetic ketoacidosis during the study.
Conclusion: The performance of the EWIS across 7 days of use was equivalent to the performance reported for a 3-day infusion set during 3 days of use. Safety outcomes during EWIS use were acceptable for the intended subcutaneous insulin infusion by an external pump for 7 days.
J. Ilany: Research Support; Self; Medtronic. O. Cohen: Employee; Self; Medtronic. N. Konvalina: None. G. Zhang: None. S. Chattaraj: Employee; Self; Medtronic.