Duration of Infusion Set Survival in Lipohypertrophy Versus Nonlipohypertrophied Tissue in Patients with Type 1 Diabetes

Abstract

Background: Improved insulin infusion set survival and faster insulin action are important issues for pump users and for the development of an artificial pancreas. The current recommendation is to change infusion sets every 3 days. Our objectives were to determine the effect of lipohypertrophy (LH) on infusion set survival and continuous glucose monitoring glucose levels. Research Design and Methods: In this multicenter crossover trial, we recruited 20 subjects (age 28.1 -9.0 years) with type 1 diabetes (duration 17.5 -8.8 years) and an area of lipohypertrophied tissue >3 cm. Subjects alternated weekly wearing a Teflon infusion set in an area of either LH or non-LH for 4 weeks. Sets were changed after (a) failure or (b) surviving 7 days of use. Results: The least-squares mean duration of infusion set survival for sets that lasted <7 days in lipohypertrophied tissue was 4.31 days compared with 4.12 days in nonlipohypertrophied tissue (P = 0.71). The average duration of set survival for individual subjects ranged from 2.2 to 7.0 days. Infusion sets in lipohypertrophied tissue failed due to hyperglycemia in 35% of subjects compared with 23% in nonlipohypertrophied tissue (P = 0.22). Both lipohypertrophied and nonlipohypertrophied tissues displayed a general increase in mean daily glucose after the third day of infusion set wear, but daily mean glucose did not differ by tissue type (P > 0.38 on each day). Conclusion: LH did not significantly affect infusion set survival or mean glucose. Achieving optimal infusion set performance requires research into factors affecting set survival. Additionally, the recommendation for duration of set change may need to be individualized.

Application of Zone Model Predictive Control Artificial Pancreas During Extended Use of Infusion Set and Sensor: A Randomized Crossover-Controlled Home-Use Trial

“…Several previous studies investigating the impact of prolonged IIS wear have shown that whereas the risk of IIS failure rises with the length of time a unit is worn, the mean glucose and TDD do not change between day 1 and day 7 of IIS wear (33,34). Similar results were seen in this study whereby the day of the study did not appear to impact the mean glucose or the percent time in hypoglycemia (Fig.…”

Detailed Analysis of Insulin Absorption Variability and the Tissue Response to Continuous Subcutaneous Insulin Infusion Catheter Implantation in Swine

“…Studies have shown that some patients indeed successfully wear CSII catheters up to 7 days. 19 , 24 In contrast, the ICs produced the highest AUC, AUC60, and C max on day 1, the fastest t max on day 3, and the lowest AUC, AUC60, and C max on day 5. Figures 1 and 2 illustrate the importance of reviewing the individual PK curves from each experiment to acknowledge the large dose-to-dose and day-to-day variability.…”

Algorithms for a Single Hormone Closed-Loop Artificial Pancreas: Challenges Pertinent to Chemical Process Operations and Control

“…The primary mitigation of these faults is the widely accepted recommendation that insulin infusion sets are changed every three days. Since there is significant variability in the lifespan of these sets [34] many infusion sets are replaced before they need to be, driving up costs and increasing patient burden. Modern infusion pumps can monitor the back-pressure on an infusion catheter, but many LISA faults do not trigger these alarms.…”