medwireNews: Insulin pump infusion set failures that result in prolonged hyperglycemia occur an average of four times per year per user and are more common in children and adolescents than adults, US study findings indicate.
The failure rate is also higher with straight Teflon sets than with angled Teflon or steel sets, report Roy Beck and colleagues from the Jaeb Center for Health Research Foundation, Inc, in Tampa, Florida.
Writing in Diabetes Technology & Therapeutics, Beck and co-authors note that patients are recommended to change insulin infusion sets every 2 to 3 days, but this “has been based on anecdotal reports and clinical experience dating back to the early 1980s.”
They also note that “[p]rolonged hyperglycemia due to inadequate insulin delivery is a common reason for early infusion set replacement” but studies assessing insulin pump infusion set failure rates are scarce.
To address this, the researchers analyzed from two clinical trials, in which 263 participants aged 6 to 72 years used 22,741 infusion sets.
Of these, 3.3% were removed before 72 hours as a result of prolonged hyperglycemia, defined as continuous glucose monitor measuring above 300 mg/dL immediately before removal and above 250 mg/dL for at least 2 hours before removal with at least 90 minutes above 300 mg/dL during that time.
The proportions changed within 48 and 24 hours due to prolonged hyperglycemia were 1.8% and 1.0%, respectively.
Beck and team found that more than half (58%) of participants needed to remove their infusion set before removal within 72 hours as a result of prolonged hyperglycemia, and the average duration of continuous time above 250 mg/dL before removal was 5.1 hours.
When the researchers used a less restrictive definition of failure related to hyperglycemia (glucose >300 mg/dL at the time of removal), they found that 7.4% of sets were removed before 72 hours.
Further analysis showed that the set failure rate with prolonged hyperglycemia was significantly lower in participants aged 18 years and older than in those aged 14–17 years or 6–13 years, at 1.9% versus 5.8% and 4.4%, respectively.
And after adjusting for infusion set type and baseline glycated hemoglobin, adolescents aged 14–17 years were a significant 2.4 times more likely to experience set failure than adults, while the youngest participants were a significant 1.8 times more likely to have set failure than the adults.
The investigators also found that set failure due to prolonged hyperglycemia was a significant two times more likely with 90° (straight insertion) Teflon sets than with angled Teflon sets and a significant 1.8 times more common than with steel sets, occurring at rates of 4.0%, 1.3%, and 1.9%, respectively.
Beck et al conclude: “While the percentage of infusion sets replaced within 72 [hours] associated with hyperglycemia is low, it still represents about four failures per year on average for each pump user based on our prolonged hyperglycemia definition and [nine] per year based on an association with hyperglycemia alone.”
They add: “This number of failures is meaningful considering that with each prolonged hyperglycemia failure, the mean time above 250 mg/dL exceeded 5 [hours] and each episode carries the risk of development of diabetic ketoacidosis.”
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