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
Abstract
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 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,…
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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”
From Frequency and Detection of Insulin Infusion Site Failure in the Type 1 Diabetes Exchange Online Community (2023) · cites this paper as [16]
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”
From Frequency and Detection of Insulin Infusion Site Failure in the Type 1 Diabetes Exchange Online Community (2023) · cites this paper as [16]
Insulin infusion set failures are common among individuals using insulin pump therapy.
“However, insulin infusion set (IIS) failures are common among individuals using insulin pump therapy.3–5”
From Clinical utility of the twiist Automated Insulin Delivery System: first study with twiist (2026) · cites this paper as [5]
Cites
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Multicenter, randomized trial of a bionic pancreas in type 1 diabetes
Bionic Pancreas Research Group (2022) · New England Journal of Medicine · doi:10.1056/nejmoa2205225 · Cited by 216 · see citing works
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Development of a Real-time Force-based Algorithm for Infusion Failure Detection
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Clinical utility of the twiist Automated Insulin Delivery System: first study with twiist
Ruiz, A., Mcdonough, A., Snow, K., Bode, B., & Mitri, J. (2026) · BMJ Open Diabetes Research & Care · doi:10.1136/bmjdrc-2026-006307
- Authors
- Kanapka, L. G., Lum, J. W., & Beck, R. W.
- Affiliations
- Jaeb Center for Health Research (US)
- Corresponding author
- Beck, Roy W.
- Venue
- Diabetes Technology & Therapeutics
- Publisher
- SAGE Publications
- Published
- 2022-05-31
- Volume
- 24
- Issue
- 6
- Pages
- 396-402
- ISSN
- 1520-9156 (ISSN-L)
- 1557-8593
- OpenAlex
- W4210734128
- Cited by
- 35
- References
- 3
- Citations by year
- 2026: 8 · 2024: 7 · 2023: 8 · 2022: 12
- FWCI
- 5.02
- Type
- journal article
- Language
- en
- Open access
- closed
- Locations
- Diabetes Technology & Therapeutics (publishedVersion)
- PubMed (publishedVersion)
- Topics
- Health Sciences › Medicine › Endocrinology, Diabetes and Metabolism › Diabetes Management and Research
- Physical Sciences › Engineering › Biomedical Engineering › Intravenous Infusion Technology and Safety
- Health Sciences › Health Professions › Emergency Medical Services › Patient Safety and Medication Errors
- Keywords
- continuous glucose monitoring, insulin pump therapy, age differences, pediatric diabetes, failure rate, diabetes management
- MeSH terms
- Adolescent, Adult, Blood Glucose, Child, Diabetes Mellitus, Type 1, Humans, Hyperglycemia, Hypoglycemic Agents, Insulin, Insulin Infusion Systems, Polytetrafluoroethylene, Steel
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