Type 1 diabetes: Extended-insulin infusion set worn for 7 days safe with high satisfaction rate

Insulin infusion sets (IISs) provide rapid-acting insulin analogs from the pump reservoir to the SC space through a Teflon cannula or a stainless steel needle held intact on the skin by an adhesive patch. Standard IISs need to be replaced every 2 to 3 days to prevent or reduce adverse events regardless of the rapid-acting insulin used. However, continuous glucose monitoring (CGM) systems often used along with CSII pump therapy can function for ≥7 days before a change in a sensor.

Against the above background, Ron Brazg, Rainier Clinical Research Center, Renton, Washington, USA, and colleagues aimed to investigate the safety and performance of a new extended-wear infusion set when used for 7 days by adults with type 1 diabetes in a single-arm, nonrandomized trial.

Adults aged 18–80 years of age with type 1 diabetes who used insulin aspart and the EIS or MiniMed 670G system with insulin lispro for up to 7 days, across 12 consecutive wears were enrolled.

Incidence of serious adverse events (SAEs), unanticipated adverse device effects (UADEs), serious adverse device effects (SADEs), severe hyperglycemia (SevHyper), severe hypoglycemia (SevHypo), skin infection, and diabetic ketoacidosis (DKA) were the safety endpoints.

The researchers also determined the EIS failure rate due to unexplained hyperglycemia, glycemic control outcomes, the overall survival rate of EIS, satisfaction with the EIS, and total daily insulin delivered.

Salient findings include:

• The intention to treat population consisting of 259 adults, 48% were men) wore a total of 3041 EIS devices.
• No UADE, SADE, or DKA events were seen.
• Overall rates of SevHypo, SAEs, SevHyper, and skin infection were 2.5, 3.8, 104.1, and 20.1 events per 100 participant-years.
• Th EIS failure rates due to unexplained hyperglycemia at the end of day 7 for insulin lispro and aspart use was respectively 0.1% and 0.4%.
• At the end of day 7, overall EIS survival rate was 77.8%, there was no change in glycemic control, and participants reported greater satisfaction with the EIS compared with standard IISs worn before the study.

"The opportunities for the advancement of IIS technology have not only included extending the IIS wear duration but also maintaining glycemic control while reducing adverse events across wear duration," the researchers wrote.

"In this study, the Medtronic extended infusion was safely worn for up to 7 days by adults without adversely affecting glycemic control and with favorable user satisfaction," they conclude.

Reference:

Ron Brazg, Satish K. Garg, Anuj Bhargava, James R. Thrasher, Kashif Latif, Bruce W. Bode, Timothy S. Bailey, Barry S. Horowitz, Arvind Cavale, Yogish C. Kudva, Kevin B. Kaiserman, George Grunberger, John Chip Reed, Sarnath Chattaraj, Gina Zhang, John Shin, Vivian Chen, Scott W. Lee, Toni L. Cordero, Andrew S. Rhinehart, Robert A. Vigersky, and Bruce A. Buckingham.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.Aug 2022.535-543.

http://doi.org/10.1089/dia.2021.0540