A Prospective Study of Insulin Infusion Set Use for up to 7 Days: Early Replacement Reasons and Impact on Glycemic Control

Few randomized studies have reported failure and survival rates when IIS devices are worn out to 7 days.

“few randomized studies have reported failure and survival rates when IIS devices are worn out to 7 days.8,9”

Prior rates of IIS failure due to unexplained hyperglycemia ranged from 19% to 30%.

“rates of IIS failure due to “unexplained hyperglycemia” (i.e., hyperglycemia >250 mg/dL and a failed correction bolus due to suspected IIS occlusion) ranged from a relatively high 19%9 to 30%.8”

Prior overall findings determined that 7-day wear, irrespective of steel or Teflon cannula, did not adversely influence glycemic control.

“Overall findings from the latter determined that 7-day wear (irrespective of steel or Teflon cannula) did not adversely influence glycemic control”

Some of the aforementioned studies reported that standard IIS survival appeared to depend heavily on the individual user, as ∼42% of Patel et al.'s study participants were able to wear an IIS for 6-7 days and 75% of those in Waldenmaier et al.'s study wore at least one standard IIS for 7 days.

“Interestingly, some of the aforementioned studies reported that standard IIS survival appeared to depend heavily on the individual user, as ∼42% of the Patel et al.'s study participants were able to wear an IIS for 6–7 days and 75% of those in Waldenmaier et al.'s study wore at least one standard IIS for 7 days.”

While early standard IIS device studies confirmed manufacturer indications for 2- to 3-day use due to increased risk of IIS site reactions or compromised glycemic control, more recent studies with greater numbers of study participants have reported minimal or no issues with glycemia over time or fewer adverse events associated with extended IIS wear.

“Thus, while early standard IIS device studies confirmed manufacturer indications for 2- to 3-day use due to increased risk of IIS site reactions or compromised glycemic control, more recent studies with greater numbers of study participants have reported minimal or no issues with glycemia over time or fewer adverse events associated with extended IIS wear.8,9,18,19”

The overall EIS survival rate by the end of day 7 was greater than previously reported survival rates for standard IIS devices worn for similar durations (69%, 63%, 43%, 33%, and 32%).

“The overall EIS survival rate of 77.8% (95% CI: 76.2–79.3) by the end of day 7 was greater than previously reported survival rates of 69% (n = 40 total participants and 80 total steel cannula sets),9 63% (n = 40 total participants, 80 total soft cannula sets),9 43% (n = 20 total participants, 40 total sets in non-lipohypertrophied tissue),18 33% (n = 20 total participants and 40 total sets in lipo”

The EIS failure rate due to unexplained hyperglycemia or both unexplained hyperglycemia and device-related SevHyper was substantially lower than the 19%, 23%, 30%, and 35% reported to be attributable or partly attributable to unexplained hyperglycemia in studies investigating extended standard IIS wear.

“The EIS failure rate due to unexplained hyperglycemia or both unexplained hyperglycemia and device-related SevHyper was quite low (≤2%) and substantially lower than the 19%,9 23%,18 30%,8 and 35%18 reported to be attributable or partly attributable to unexplained hyperglycemia in the studies investigating extended standard IIS wear.”

In Waldenmaier et al.'s study, participants could use an accompanying insertion device, and no issues with kinking at IIS insertion were reported.

“While a different Teflon-cannula IIS device (YpsoPump™ Orbit™ soft infusion set [Ypsomed AG, Burgdorf, Switzerland]) was used in Waldenmaier et al.'s study, participants could use an accompanying insertion device, and no issues with kinking at IIS insertion were reported.9”

There were multiple definitions of a failed correction dose, with 1 h or 60-90 min as the elapsed time by when a single correction dose was required to decrease BG by 50 mg/dL.

“There were also multiple definitions of a failed correction dose where 1 h8,18 or 60–90 min9 was the elapsed time by when a single correction dose was required to decrease BG by 50 mg/dL.”