Pilot Study for Assessment of Optimal Frequency for Changing Catheters in Insulin Pump Therapy—Trouble Starts on Day 3
Open accessAbstract
Background: Continuous subcutaneous insulin infusion (CSII) by means of insulin pump devices is considered to be one of the most optimal therapies to achieve treatment targets in patients with diabetes mellitus. In CSII, the insulin is delivered through Teflon catheters or steel needle infusion sets, which need to be renewed on a regular basis. This pilot study was performed to investigate the optimal change frequency in daily practice and to explore potential problems that may occur when the sets are used for a more prolonged time than the recommended up to 72 hours of usage (Teflon catheters). Method: Twelve patients with type 1 diabetes participated in the trial [age (mean ± STD): 40.3 ± 12.6 years, body mass index: 26.2 ± 3.3 kg/m 2 , hemoglobin A1c: 6.7 ± 0.6%]. They were asked to wear their infusion set (Comfort™ or Silhouette®) for increasing periods of 1, 2, 3, 4, and 5 days. After each use, patients completed standardized questionnaires regarding technical and medical issues associated with infusion set use. A health care professional investigated the infusion sites and infusion sets and completed an “infusion set inspection” questionnaire. Blood glucose was measured and recorded to assess a potential Influence of duration of catheter use on glycemic control. Results: Infusion set and injection site problems (itching, bruising, swelling, and pain) started to occur in measurable amounts on the 3rd day of catheter use, and about 40% of patients reported significant issues when using a catheter for 5 days. In parallel, there was a consistent increase in mean daily blood glucose levels that correlated with the number of days of catheter use (e.g., day 1: 7. 5 ± 3.8 mmol/liter, day 3: 8.4 ± 4.2 mmol/liter, day 5: 9.0 ± 4.0 mmol/liter, day 7: 11.6 ± 2.2 mmol/liter, p < 0.05 vs day 1). Conclusions: Using the catheters for 2 days resulted in a safe and well-tolerated therapy. Clinically relevant adverse events started to occur during the 3rd day and their incidence increased constantly with longer use. This was associated with undesired changes in mean glycemic control. Data support the recommendation by the drug and device manufacturers that insulin pump catheters should only be used for 48–72 hours to avoid adverse events and potential metabolic deterioration.
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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”
From Frequency and Detection of Insulin Infusion Site Failure in the Type 1 Diabetes Exchange Online Community (2023) · cites this paper as [6]
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 measuredDespite recent improvements in CSII catheter design and insertion method, the CSII catheter remains the weak link of an insulin infusion system for the management of type 1 diabetes.
“Despite recent improvements in CSII catheter design and method of insertion, the CSII catheter remains the weak link of an insulin infusion system for the management of type 1 diabetes.”
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 [6]
The Abstract (page unavailable) reports that infusion-set and injection-site problems began to occur in measurable amounts on day 3 in patients with type 1 diabetes. The Discussion (page unavailable) also describes catheter-related disruptions to insulin delivery. Our copy does not establish that catheter design or insertion methods had recently improved, or compare the catheter with other components to call it the system’s weak link. (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 [6]
The Introduction recommends changing infusion sets every 48–72 hours, and the Discussion says prolonged use appeared to change insulin absorption and reduce glycemic control. But the study measured blood glucose, not variability in insulin absorption, and does not establish that increasing absorption variability is why patients routinely change catheters. (LLM, conf=0.84)
Experimental — accuracy not yet measuredPatients commonly experience an insulin bolus that fails to produce the expected glucose lowering effect, leading to persistent hyperglycemia.
“Patients commonly experience an insulin bolus that fails to produce the expected glucose lowering effect, leading to persistent hyperglycemia.6,19”
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 [6]
The Discussion (page unavailable) says disrupted pump delivery or prolonged catheter use can impair insulin absorption, and reports rising mean blood glucose with longer catheter use. It does not establish that a bolus commonly fails to lower glucose as expected or that this leads to persistent hyperglycemia. (LLM, conf=0.82)
Experimental — accuracy not yet measuredInfusion set failure can occur when there is local inflammation at the infusion site, when the catheter is occluded, kinked or has simply dislodged from the subcutaneous space.
“Infusion set failure can occur when there is local inflammation at the infusion site, when the catheter is occluded, kinked or has simply dislodged from the subcutaneous space.3,4”
From Early Detection of Infusion Set Failure During Insulin Pump Therapy in Type 1 Diabetes (2016) · cites this paper as [3]
This observation is consistent with published animal studies, human clinical trials, and routine clinical care.
“This observation is consistent with published animal studies, human clinical trials, and routine clinical care.5,6,22,23”
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 [6]
Standard 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 [2]
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 [2]
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 [2]
Schmid et al.'s pilot study reported average BG levels that increased from 135.0 ± 68.4 mg/dL to 208.8 ± 39.6 mg/dL from day 1 to 7 of IIS wear.
“The Schmid et al.'s pilot study of 12 adults (40.3 ± 12.6 years of age) using the MiniMed Comfort infusion set or MiniMed Silhouette infusion set (ConvaTec Unomedical A/S, Lejre, Denmark) reported average BG levels that increased from 135.0 ± 68.4 mg/dL to 208.8 ± 39.6 mg/dL from day 1 to 7 of IIS wear.2”
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 [2]
In Schmid et al.'s study, events resulting in IIS change occurred more frequently after day 3 and impaired insulin absorption resulting in hyperglycemia was significant by day 7.
“While only a few study participants reached 7-day IIS wear, events resulting in IIS change occurred more frequently after day 3 and impaired insulin absorption resulting in hyperglycemia was significant by day 7.”
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 [2]
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- Authors
- Schmid, V., Hohberg, C., Borchert, M., Forst, T., & Pfützner, A.
- Affiliations
- Institut für Klinische Forschung und Entwicklung (DE)
- Corresponding author
- Pfützner, Andreas
- Venue
- Journal of Diabetes Science and Technology
- Publisher
- SAGE Publications
- Published
- 2010-07
- Volume
- 4
- Issue
- 4
- Pages
- 976-982
- ISSN
- 1932-2968 (ISSN-L)
- PMC
- PMC2909532
- OpenAlex
- W1966562602
- Cited by
- 97
- References
- 24
- Citations by year
- 2026: 3 · 2025: 1 · 2024: 6 · 2023: 11 · 2022: 10 · 2021: 4 · 2020: 4 · 2019: 5 · 2018: 11 · 2017: 5 · 2016: 7 · 2015: 14 · 2014: 6 · 2013: 4 · 2012: 4
- FWCI
- 2.42
- Type
- journal article
- Language
- en
- Open access
- bronze
- doi.org
- Locations
- Journal of Diabetes Science and Technology (publishedVersion)
- Europe PMC (PubMed Central) (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 › Medicine › Endocrinology, Diabetes and Metabolism › Diabetes Management and Education
- Keywords
- insulin pump therapy, catheter dwell time, Teflon catheter, type 1 diabetes, glycemic control, adverse events, blood glucose variability, patient-reported outcomes, glycemic variability, hypoglycemia, hyperglycemia
- MeSH terms
- Adult, Blood Glucose, Catheterization, Diabetes Mellitus, Type 1, Female, Humans, Insulin Infusion Systems, Male, Middle Aged, Pilot Projects, Polytetrafluoroethylene, Prospective Studies, Surveys and Questionnaires, Skin, Blood Glucose Self-Monitoring, Kaplan-Meier Estimate, Young Adult
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