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Evaluation of Extended Infusion Set Performance in Adults with Type 1 Diabetes: Infusion Set Survival Rate and Glycemic Outcomes from a Pivotal Trial. Diabetes technology & therapeutics Brazg, R. L., Garg, S. K., Bhargava, A., Thasher, J. R., Latif, K., Bode, B. W., Bailey, T. S., Horowitz, B. S., Cavale, A., Kudva, Y. C., Kaiserman, K. B., Grunberger, G., Reed, J. H., Chattaraj, S., Zhang, G., Shin, J., Chen, V., Lee, S. W., Cordero, T. L., Rhinehart, A. S., Vigersky, R. A., Buckingham, B. A. 2022

Abstract

BACKGROUND: Standard insulin infusion sets (IISs) are to be replaced every two-to-three days to avoid complications and diabetic ketosis due to set failure. This pivotal trial evaluated the safety and performance of a new extended-wear infusion set (EIS) when used for seven days by adults with type 1 diabetes (T1D).METHOD: This single-arm, non-randomized trial enrolled adults (aged 18-80 years) with T1D who used their own MiniMed 670G system with insulin lispro or insulin aspart and the EIS for up to seven days, across 12 consecutive wears. Safety endpoints included incidence of serious adverse events (SAEs), serious adverse device effects (SADEs), unanticipated adverse device effects (UADEs), severe hypoglycemia (SevHypo) and severe hyperglycemia (SevHyper), diabetic ketoacidosis (DKA) and skin infection. Effectiveness endpoints included EIS failure due to unexplained hyperglycemia (i.e., suspected occlusion) and overall EIS survival at end of 7-day wear. Exploratory endpoints included change in glycemic outcomes (i.e., A1C, mean glucose and percentage of time at glucose ranges), total daily insulin dose and satisfaction with the EIS.RESULTS: The intention to treat population (n=259, 48% men, 45.0±14.1 years) wore a total of 3,041 EIS devices. No SADEs, UADEs, or DKA events were reported. Overall rates of SAEs, SevHypo, SevHyper and skin infection were 3.8, 2.5, 104.1 and 20.1 events per 100 participant-years. The rate of EIS failure due to unexplained hyperglycemia at end of day 7 was 0.1% (95% C.I., 0.03-0.51%) and 0.4% (95% CI, 0.16-1.00%) for insulin lispro and aspart use, respectively. The overall EIS survival rate was 77.8% (C.I. 76.2%-79.3%) and participants reported greater satisfaction with the EIS compared with standard IISs worn before the study (p<0.001).CONCLUSIONS: This investigation demonstrated that the EIS, when worn for up to seven days, was safe and rated with high satisfaction, without adversely affecting glycemic control in adults with T1D.

View details for DOI 10.1089/dia.2021.0540

View details for PubMedID 35263188