Frequency and Detection of Insulin Infusion Site Failure in the Type 1 Diabetes Exchange Online Community

May combine two claims.

IIS failures are the primary contributor to DKA development and the leading cause of DKA-related hospitalizations among insulin pump users.

“Correspondingly, IIS failures are the primary contributor to DKA development and the leading cause of DKA-related hospitalizations among insulin pump users.[9][10][11][12]”

• cites [9] sourceSupported
• cites [10] sourceSupported
• cites [11] sourcePartly supported

  The Abstract and Conclusions state that infusion set failures can cause DKA in people with type 1 diabetes using pumps. They do not establish that these failures are the primary contributor to DKA or the leading cause of DKA-related hospitalizations among pump users. Page numbers are unavailable in our copy. (LLM, conf=0.87)

  Experimental — accuracy not yet measured
• cites [12] sourceCould not verify

  The Results and Conclusions (page unavailable) report worsening glycemic control when pump infusion lines were used beyond 48 hours. Our copy does not address whether infusion-set failures are the primary contributor to DKA or the leading cause of DKA-related hospitalizations; searches for DKA, ketoacidosis, and hospital admissions found no supporting passage. (LLM, conf=0.76)

  Experimental — accuracy not yet measured

May combine two claims.

Without recognition and replacement, IIS failures lead to inadequate insulin delivery, hyperglycemia, and increased risk for diabetes-related ketoacidosis (DKA).

“Without recognition and replacement, IIS failures lead to inadequate insulin delivery, hyperglycemia, and increased risk for diabetes-related ketoacidosis (DKA).2,5,8,9”

• cites [2] sourceNot checked — no full text of the source
• cites [5] sourceSupported
• cites [8] sourceNot checked — no full text of the source
• cites [9] sourceSupported

Probably not a substantial claim: may not pass S3 (load-bearing).

IIS failure is most often attributed to cannula-associated issues (kinking, occlusion, and dislodgement) or insertion site inflammation/infection.

“IIS failure is most often attributed to cannula-associated issues (kinking, occlusion, and dislodgement) or insertion site inflammation/infection.2,6,7”

• cites [2] sourceNot checked — no full text of the source
• cites [6] sourcePartly supported

  The Discussion lists kinking, pulling out, occlusion, and skin irritation among infusion-set problems, and says infection can occur. But it does not establish that the claimed categories are the most frequent causes of IIS failure; it calls infection rare, and the study’s most frequent reason for premature set changes was leakage (Patient Characteristics; page unavailable). (LLM, conf=0.86)

  Experimental — accuracy not yet measured
• cites [7] sourcePartly supported

  The Discussion (page not provided) identifies kinking or bending of the cannula as this study’s most frequent failure event and reports blockage as a common infusion-set problem in a cited survey. The paper also describes sets pulling out and insertion-site irritation, but the passages do not establish inflammation or infection as among the most frequent causes of IIS failure. (LLM, conf=0.84)

  Experimental — accuracy not yet measured

May combine two claims.

Occlusion alarms are often triggered after delays >2 h or not at all.

“This is unsurprising, as occlusion alarms are often triggered after delays >2 h or not at all.20”

• cites [20] sourceSupported

Probably not a substantial claim: may not pass S2 (checkable).

Detection of true causative associations between IIS failure rates and IIS characteristics will require prospective randomization, likely using each individual as their own control.

“Ultimately, detection of true causative associations between IIS failure rates and IIS characteristics will require prospective randomization, likely using each individual as their own control in light of the findings by Patel et al. 3”

• cites [3] sourceSupported

May combine two claims.

Among participants reporting IIS failure, the most common initial action was giving a pump bolus without IIS replacement (47.7%), followed by replacing the IIS and then giving a pump bolus (43.5%).

“The most reported initial action taken after an IIS failure was discovered, giving a pump bolus without IIS replacement (47.7%), followed by replacing the IIS and then giving a pump bolus (43.5%).”

Probably not a substantial claim: may not pass S3 (load-bearing).

The final analysis included 707 responses, comprising 631 (89.3%) adults with diabetes on insulin pump and 76 (10.7%) caregivers.

“Final analysis included 707 responses, comprising 631 (89.3%) adults with diabetes on insulin pump and 76 (10.7%) caregivers.”

May combine two claims.

Among participants reporting any history of IIS failure, the most common method of first being alerted was experiencing hyperglycemia on glucometer or CGM (56.2%), followed by pump alarm (25.0%).

“Of participants reporting any history of IIS failure, 56.2%, 25.0%, 9.9%, 5.7%, and 3.2% reported that their most common method of first being alerted to an IIS failure was by experiencing hyperglycemia on glucometer or CGM, a pump alarm, hyperglycemia symptoms, a site-specific issue (see/ smell/feel insulin leak, inflammation, and swelling), or unknown/not alerted, respectively.”

• Also stated in: § Abstract · plain

  “IIS failure is usually detected through development of hyperglycemia rather than pump alarm.”

• Also stated in: § Conclusions · plain

  “Most commonly, the first indication of IIS failure was after hyperglycemia already developed.”

May combine two claims.

The retrospective survey has limitations including sample bias from using a voluntary online English-only survey and potential for misestimations of event frequencies or glycemic parameters from reliance on self-reported data.

“This retrospective survey has several limitations, including sample bias from using a voluntary online English-only survey and potential for misestimations of event frequencies or glycemic parameters from reliance on self-reported data, contingent upon participant understanding and recall.”

Probably not a substantial claim: may not pass S3 (load-bearing). May combine two claims.

Incompatible IIS characteristics were encountered on 102 (14%) surveys; in each case, all IIS characteristics were removed from analysis, but the remainder of survey responses were included.

“Incompatible IIS characteristics (e.g., a reported infusion site type that does not offer the reported cannula length) were encountered on 102 (14%) surveys.In each case, all IIS characteristics were removed from analysis, but the remainder of survey responses were included.”

Probably not a substantial claim: may not pass S3 (load-bearing). May combine two claims.

Participants aged <18 years or with higher baseline HbA1c had greater odds of IIS failure using a definition of prolonged (≥2 h) hyperglycemia before IIS exchange.

“In contrast, a recent posthoc analysis by Kanapka et al. examining 22,741 infusion site wears among 263 participants across two clinical trials found that participants aged <18 years or with higher baseline HbA 1c had greater odds of IIS failure using a definition of prolonged ( ‡2 h) hyperglycemia before IIS exchange.16”

• cites [16] sourceNot checked — no full text of the source

May combine two claims.

Kanapka et al. found higher rates of IIS failure in association with 90° Teflon cannulas, but a difference between steel and angled Teflon cannulas was not apparent.

“In their analysis, Kanapka et al. found higher rates of IIS failure in association with 90° Teflon cannulas, but a difference between steel and angled Teflon cannulas was not apparent.16”

• cites [16] sourceNot checked — no full text of the source

Classified as probably not a substantial claim. May combine two claims.

The definition of IIS failure is subjective, and the broader definition used does not include a time component, which may affect individual recognition variability.

“Importantly, the definition of IIS failure is also subjective, and the broader definition used does not include a time component, which may affect individual recognition variability.”

Probably not a substantial claim: may not pass S3 (load-bearing). May combine two claims.

Previous studies have shown steel cannulas have better durability of favorable IIS properties and greater resistance to kinking than Teflon.

“Previous studies have shown steel cannulas have better durability of favorable IIS properties and greater resistance to kinking than Teflon.18”

• cites [18] sourceNot checked — no full text of the source

Probably not a substantial claim: may not pass S3 (load-bearing). May combine two claims.

The median duration of pump use of 14 years with IQR of 7 years suggests respondents were very experienced users and are likely to be more attuned to IIS failure than those who are new to pump therapy or have shorter duration of use.

“The median duration of pump use of 14 years with IQR of 7 years suggests respondents were very experienced users and are likely to be more attuned to IIS failure than those who are new to pump therapy or have shorter duration of use.”

May combine two claims.

IIS failures are frequent and unpredictable, typically require hyperglycemia for detection, and are associated with negative perceptions (burnout and consideration of pump discontinuation).

“IIS failures are frequent and unpredictable, typically require hyperglycemia for detection, and are associated with negative perceptions.”

• Also stated in: § Conclusions · plain

  “In summary, these data provide valuable information on the frequency, unpredictability, and burdens of IIS failure, which often go undetected until hyperglycemia develops.This is associated with burnout and discontinuation of pump use.”

• AssumptionRests on an assumption: Fewer IIS failures are better because even a single failure can affect glycemic control.

Probably not a substantial claim: may not pass S2 (checkable).

Detecting IIS failure earlier, before hyperglycemia develops, represents an important gap.

“Therefore, detecting IIS failure earlier, before hyperglycemia develops, represents an important gap.”

Probably not a substantial claim: may not pass S3 (load-bearing).

The analysis and publication were approved retrospectively by the Children's Hospital Los Angeles Institutional Review Board.

“waiver for analysis and publication was obtained retrospectively from the Children's Hospital Los Angeles Institutional Review Board.”

Probably not a substantial claim: may not pass S2 (checkable). May combine two claims.

Self-estimated IIS failure frequency has a strong potential for general underestimation, and there is additional potential for desirability bias.

“Even still, self-estimated IIS failure frequency has a strong potential for general underestimation, and there is additional potential for desirability bias, in which participants may feel pressure/embarrassment/self-conscious, and under-report IIS wear time.”

Probably not a substantial claim: may not pass S2 (checkable), S3 (load-bearing), S4 (based).

Those who elect to use a specific IIS type may have done so previously to address a prior higher proclivity toward IIS failure, diminishing an otherwise perceivable difference in effect.

“Finally, those who elect to use a specific IIS type may have done so previously to address a prior higher proclivity toward IIS failure, diminishing an otherwise perceivable difference in effect.”