Using Insulin Infusion Sets in CSII for Longer Than the Recommended Usage Time Leads to a High Risk for Adverse Events: Results From a Prospective Randomized Crossover Study
Open accessAbstract
Background: Infusion sets for use with insulin pumps are recommended for use for 2 to 3 days to avoid local skin reactions, for example, to the insulin formulation and preservatives like meta-cresol. However, many patients use the catheters longer for economic reasons. We performed this study to investigate the tolerability of 2-day use of infusion sets in comparison to 4-day use in a real-world setting. Methods: This prospective randomized controlled crossover study with 2 × 3-month observation periods was performed with 24 type 1 patients. At baseline, patients were trained on the use of the infusion system (Medtronic /Mio® or inset™ II) and randomized to any of the 2 treatment sequences. Observation parameters included glycemic control, frequency and nature of device-related, and procedure-related adverse events and patient preference. Results: The per-protocol analysis was performed with 22 patients (5 men, 17 women, age 39 ± 11 years, BMI 27.0 ± 3.5 kg/m2). The number of catheter related adverse events was 290 with 2-day use versus 495 with 4-day use ( P < .05). The overall number of treatment related events was 750 with 2-day use versus 934 with 4-day use ( P < .001). There was no difference in glycemic control between the treatment arms. Treatment satisfaction was higher with 2-day use (very high/high satisfaction: 90.4% versus 4 day-use: 77.3%, P < .05). Conclusion: Our results demonstrate that using the infusion sets for a longer usage period of 2-3 days resulted in a clinically relevant increase in treatment-related tolerability problems. Patients should be trained and encouraged not to use insulin pump infusion sets for a longer than the recommended time period.
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Longer IIS wear duration >3 days has been associated with higher number of catheter-related adverse events, including hyperglycemia, site reactions, and silent occlusions.
“In addition, longer IIS wear duration >3 days has been associated with higher number of catheter-related adverse events, including hyperglycemia (blood glucose >250 mg/dL), site reactions, and ''silent occlusions.''7,12,17”
From Frequency and Detection of Insulin Infusion Site Failure in the Type 1 Diabetes Exchange Online Community (2023) · cites this paper as [7]
The Results report more catheter-related adverse events with 4-day than 2-day wear, including hyperglycemic events above 250 mg/dL and injection-site reactions (page unavailable). The paper mentions occlusions as a potential technical problem and says used sets were inspected for them, but our copy does not identify increased *silent* occlusions with longer wear. (LLM, conf=0.87)
Experimental — accuracy not yet measuredIIS 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”
From Frequency and Detection of Insulin Infusion Site Failure in the Type 1 Diabetes Exchange Online Community (2023) · cites this paper as [7]
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 measuredPatients routinely insert a new CSII catheter every 2-3 days because insulin absorption into the circulation becomes more variable and less reliable over time.
“Patients routinely insert a new catheter every 2–3 days due to increasing variability of insulin absorption over time.”
From Detailed Analysis of Insulin Absorption Variability and the Tissue Response to Continuous Subcutaneous Insulin Infusion Catheter Implantation in Swine (2017) · cites this paper as [9]
The Discussion recommends changing infusion sets every 2–3 days, and the introductory passage under Abstract says longer use appeared to change insulin absorption and worsen glycemic control. The paper does not establish increasing variability of absorption as the reason patients routinely change catheters; it also gives skin reactions and other adverse effects as reasons for the recommended interval. (LLM, conf=0.85)
Experimental — accuracy not yet measuredStandard insulin infusion sets should be changed every 2 to 3 days to prevent or reduce adverse events.
“Standard IISs should be changed every 2 to 3 days,1–3 regardless of rapid-acting insulin used,4 to prevent or reduce adverse events (e.g., site failure resulting in hyperglycemia, skin inflammation, infection or pain at the IIS site, adhesive patch failure, etc.).”
From Evaluation of Extended Infusion Set Performance in Adults with Type 1 Diabetes: Infusion Set Survival Rate and Glycemic Outcomes from a Pivotal Trial (2022) · cites this paper as [1]
Early feasibility and pilot IIS studies showed significant device-related adverse events that included increased hyperglycemia and functional or mechanistic issues with IIS use during longer durations of wear.
“While early feasibility and pilot IIS studies showed significant device-related adverse events that included increased hyperglycemia and functional or mechanistic issues with IIS use during longer durations of wear,1–3”
From Evaluation of Extended Infusion Set Performance in Adults with Type 1 Diabetes: Infusion Set Survival Rate and Glycemic Outcomes from a Pivotal Trial (2022) · cites this paper as [1]
Early studies of extended standard IIS wear demonstrated deterioration in glycemic control and significant IIS- or IIS site-related adverse events.
“Early studies of extended standard IIS wear demonstrated deterioration in glycemic control and significant IIS- or IIS site-related adverse events.1–3”
From Evaluation of Extended Infusion Set Performance in Adults with Type 1 Diabetes: Infusion Set Survival Rate and Glycemic Outcomes from a Pivotal Trial (2022) · cites this paper as [1]
A definite link between the frequency of insulin pump occlusions and elevation of A1C has not been demonstrated.
“Insulin pump occlusions are felt by many diabetes professionals to impair blood glucose control,1 although a definite link between occlusion frequency and elevation of A1C has not been demonstrated.2,3”
From Insulin Pump Occlusions: For Patients Who Have Been Around the (Infusion) Block (2017) · cites this paper as [3]
The Results report HbA1c by infusion-set wear time, while the Discussion mentions catheter occlusions without relating their frequency to HbA1c. Our copy does not assess that relationship or state whether a definite link has been demonstrated (searched: occlusion frequency, HbA1c, and glycemic control). (LLM, conf=0.72)
Experimental — accuracy not yet measuredThe follow-up 3-month randomized crossover study reported a trending increase in IIS-related issues including hyperglycemia, increased frequency of IIS changes (from 73 to 143 changes), increased number of infusion set-related adverse events (from 305 to 517 events), and site reactions (from 1.7 ± 2.2 to 7.5 ± 14.0 events/participant), all of which were significant.
“The follow-up 3-month randomized crossover study1 with 22 adults (39.0 ± 11.0 years of age) using the MiniMed Mio infusion set or Inset II™ infusion set (ConvaTec Unomedical A/S) also reported a trending increase in IIS-related issues that included hyperglycemia, increased frequency of IIS changes (from 73 to 143 changes), increased number of infusion set-related adverse events (from 305 to 517”
From Evaluation of Extended Infusion Set Performance in Adults with Type 1 Diabetes: Infusion Set Survival Rate and Glycemic Outcomes from a Pivotal Trial (2022) · cites this paper as [1]
It is currently recommended that insulin infusion sets are changed every two to three days.
“It is currently recommended that insulin infusion sets are changed every two to three days, 16,28”
From Real-Time Detection of Infusion Site Failures in a Closed-Loop Artificial Pancreas (2018) · cites this paper as [28]
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Practical Approaches to Insulin Pump Troubleshooting for Inpatient Nurses
Tran, A., & Roman, D. (2026) · Journal of Infusion Nursing · doi:10.1097/nan.0000000000000634
Bhambhani, A., Wei, J. Y., Zhang, H., & Shi, C. (2026) · Advanced Drug Delivery Reviews · doi:10.1016/j.addr.2026.115958
Groisman, L., Thorson, T. J., Saudi, B., Myrick, R. J., Gonthier, A. R., Nelson, G., Loeum, C., Torjman, M. C., Joseph, J. I., Mohraz, A., et al. (2026) · Biomaterials Advances · doi:10.1016/j.bioadv.2026.215155
- Authors
- Pfützner, A., Sachsenheimer, D., Grenningloh, M., Heschel, M., Walther-Johannesen, L., Gharabli, R., & Klonoff, D.
- Affiliations
- Pfützner Science & Health Institute, Mainz, Germany
- Clinlogix (Germany) (DE)
- Convatec/Unomedical, Lejre, Denmark
- Mills Peninsula Health Services (US)
- Corresponding author
- Pfützner, Andreas
- Venue
- Journal of Diabetes Science and Technology
- Publisher
- SAGE Publications
- Published
- 2015-09-03
- Volume
- 9
- Issue
- 6
- Pages
- 1292-1298
- ISSN
- 1932-2968 (ISSN-L)
- PMC
- PMC4667306
- OpenAlex
- W1849011750
- Cited by
- 53
- References
- 25
- Citations by year
- 2026: 4 · 2025: 1 · 2024: 4 · 2023: 7 · 2022: 7 · 2021: 3 · 2020: 4 · 2019: 3 · 2018: 10 · 2017: 4 · 2016: 5 · 2015: 1
- FWCI
- 5.80
- Type
- journal article
- Language
- en
- Open access
- green
- www.ncbi.nlm.nih.gov
- Locations
- Journal of Diabetes Science and Technology (publishedVersion)
- PubMed Central (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 › Central Venous Catheters and Hemodialysis
- Keywords
- insulin pump therapy, type 1 diabetes, catheter-related complications, local skin reactions, glycemic control, patient satisfaction, treatment tolerability
- MeSH terms
- Adult, Blood Glucose, Diabetes Mellitus, Type 1, Disposable Equipment, Equipment Design, Female, Germany, Humans, Hypoglycemic Agents, Insulin, Insulin Infusion Systems, Male, Middle Aged, Prospective Studies, Risk Factors, Time Factors, Biomarkers, Treatment Outcome, Cross-Over Studies, Infusions, Subcutaneous, Patient Preference, Catheters
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