Insulin Pump Infusion Set Failures Associated with Prolonged Hyperglycemia: Frequency and Relationship to Age and Type of Infusion Set During 22,741 Infusion Set Wears.

Background: Although insulin pump infusion set failures are common, studies assessing the failure rate are limited. Methods: Data were analyzed from two clinical trials, in which 263 participants aged 6-72 years used 22,741 infusion sets. The frequency of removal due to prolonged hyperglycemia (continuous glucose monitor measuring >300 mg/dL immediately before removal and >250 mg/dL continuously for at least 2 h before removal with at least 90 min >300 mg/dL out of the prior 120 min) was determined. Differences in failure rates among age groups and infusion set types were evaluated. Results: Among 22,741 infusion sets, 748 (3.3%) were removed before 72 h in association with prolonged hyperglycemia. The percentage replaced within 48 h and within 24 h with prolonged hyperglycemia were 1.8% and 1.0%, respectively. Mean duration of continuous time >250 mg/dL before removal was 5.1 ± 3.7 h. Using a less restrictive definition of failure related to hyperglycemia, 1688 (7.4%) sets were removed before 72 h with a glucose level >300 mg/dL at the time of removal. The frequency of insulin set failure with prolonged hyperglycemia was lower in adults ≥18 years old (1.9%) than in those 14-17 years old (5.8%, P  < 0.001) or 6-13 years old (4.4%, P  = 0.002). The 90° Teflon sets had the highest frequency of prolonged hyperglycemia failure within 72 h (4.0%) compared with the angled Teflon set frequency (1.3%, P  = 0.01) or the steel set frequency (1.9%, P  = 0.006). Conclusions: Based on the data from these 22,741 infusion sets, infusion set changes associated with prolonged hyperglycemia occur on average about four times a year, with the frequency being higher in youth than adults. The frequency also appears to be higher with straight Teflon sets compared with angled Teflon sets and steel sets. Clinical Trials Registration Number: NCT03563313.