Randomized Trial of Infusion Set Function: Steel Versus Teflon
Open accessAbstract
Background: This study compared infusion set function for up to 1 week using either a Teflon ® (Dupont ™ , Wilmington, DE) catheter or a steel catheter for insulin pump therapy in type 1 diabetes mellitus. Subjects and Methods: Twenty subjects participating in a randomized, open-labeled, crossover study were asked to wear two Quick-Set ® and two Sure-T ® infusion sets (both from Medtronic Minimed, Northridge, CA) until the infusion set failed or was worn for 1 week. All subjects wore a MiniMed continuous glucose monitoring system for the duration of the study. Results: One subject withdrew from the study. There were 38 weeks of Sure-T wear and 39 weeks of Quick-Set wear with no difference in the survival curves of the infusion sets. There was, however, a 15% initial failure rate with the Teflon infusion set. After 7 days, both types of infusion sets had a 64% failure rate. Overall, 30% failed because of hyperglycemia and a failed correction dose, 13% were removed for pain, 10% were pulled out by accident, 10% had erythema and/or induration of>10 mm, 5% fell out because of loss of adhesion, and 4% were removed for infection. The main predictor of length of wear was the individual subject. There was no increase in hyperglycemia or daily insulin requirements when an infusion set was successfully used for 7 days ( n =25 of 77 weeks). Conclusions: We found no difference between steel and Teflon infusion sets in their function over 7 days, although 15% of Teflon sets failed because of kinking on insertion. The strongest predictor of prolonged 7-day infusion set function was the individual subject, not the type of infusion set.
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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”
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 [8]
The citation is attached to the claimed 69% steel and 63% soft-cannula survival rates. The paper’s Results instead report that, at the end of day 7, 32% of steel sets and 33% of Teflon sets were functioning (page unavailable). (LLM, conf=0.88)
Checked by a reasoning model — may be wrong.
Experimental — accuracy not yet measuredSilent occlusions contribute to the occurrence of unexplained hyperglycemia and glycemic variability in patients using CSII.
“Based on our findings as well as previous reports,15,16,18 we believe that silent occlusions contribute to the occurrence of unexplained hyperglycemia and glycemic variability in patients using CSII.”
From Reduced Silent Occlusions with a Novel Catheter Infusion Set (BD FlowSmart): Results from Two Open-Label Comparative Studies (2016) · cites this paper as [15]
The Discussion (page not available) describes unexplained hyperglycemia in CSII users that resolves after changing the infusion set, and reports unexpected hyperglycemia and/or infusion-set occlusion. It does not identify those occlusions as silent or establish that they contribute to glycemic variability. (LLM, conf=0.84)
Experimental — accuracy not yet measuredA 15% failure rate of polymer catheters over the 8-h period following insertion was observed by Patel et al., and nearly 9% of soft cannula insertions failed within a 6-h period by Renard et al.
“Furthermore, a 15% failure rate of polymer catheters (blood glucose value of >250 mg/dL and not decreasing at least 50 mg in 1 h post–correction bolus) over the 8-h period following insertion was observed by Patel et al.15 and in nearly 9% of soft cannula insertions within a 6-h period by Renard et al,16 suggesting that existing polymer catheters have a tendency to fail upon insertion.”
From Reduced Silent Occlusions with a Novel Catheter Infusion Set (BD FlowSmart): Results from Two Open-Label Comparative Studies (2016) · cites this paper as [15]
The Results report a 15% failure rate on initial insertion of Teflon catheters due to kinking, detected hours later. They do not specify that all 15% failed within 8 hours; the Results describe those failures as occurring on the first day. The Introduction also gives a different primary failure threshold (>300 mg/dL), though the analysis included eight events above 250 mg/dL with an unsuccessful correction bolus. The Renard finding has a separate citation and is not judged here. (LLM, conf=0.88)
Experimental — accuracy not yet measuredPatel et al. found that the strongest predictor of IIS failure was by individual rather than IIS type.
“However, in an open-label crossover study comparing 90° Teflon with steel, Patel et al. found that the strongest predictor of IIS failure was by individual rather than IIS type.3”
From Frequency and Detection of Insulin Infusion Site Failure in the Type 1 Diabetes Exchange Online Community (2023) · cites this paper as [3]
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”
From Frequency and Detection of Insulin Infusion Site Failure in the Type 1 Diabetes Exchange Online Community (2023) · cites this paper as [3]
The success of insulin pump therapy may be dependent on the robustness of insertion methods to avoid catheter kinking and failed delivery of insulin into the tissue.
“The success of insulin pump therapy may further be dependent on the robustness of insertion methods to avoid issues such as catheter kinking and therefore failed delivery of insulin into the tissue.”
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 [19]
Patients 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 [19]
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”
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 [8]
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.”
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 [8]
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.”
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 [8]
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.”
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 [8]
The observed infusion set duration is comparable to infusion set durations observed in previous studies.
“The observed infusion set duration is comparable to infusion set durations observed in previous studies. 15,29”
From Real-Time Detection of Infusion Site Failures in a Closed-Loop Artificial Pancreas (2018) · cites this paper as [29]
Informed alarms dictating the appropriate patient-directed intervention potentially increase safety in advanced diabetes technology by improving the interactions between patients and technology.
“Informed alarms dictating the appropriate patient-directed intervention potentially increase safety in advanced diabetes technology by improving the interactions between patients and technology. 29”
From Real-Time Detection of Infusion Site Failures in a Closed-Loop Artificial Pancreas (2018) · cites this paper as [29]
The Introduction (pp. 15–19; passage page unspecified) describes patients checking glucose and changing infusion sets when glucose did not improve. A search for alarms and alerts found no passage addressing whether alarms that specify patient interventions improve safety or patient–technology interactions. (LLM, conf=0.73)
Experimental — accuracy not yet measuredPrior 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”
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 [8]
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”
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 [8]
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”
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 [8]
Patel et al. indicated that kinking at initial insertion of Teflon-cannula IISs contributed to 15% of the total IIS failure rate, although investigational staff inserted all IIS devices during the study.
“For instance, Patel et al., indicated that kinking at initial insertion of Teflon-cannula IISs (MiniMed Quick-Set infusion set [Medtronic]) contributed to 15% of the total IIS failure rate, although investigational staff inserted all IIS devices during the study.8”
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 [8]
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- Authors
- Patel, P. J., Benasi, K., Ferrari, G., Evans, M. G., Shanmugham, S., Wilson, D. M., & Buckingham, B. A.
- Affiliations
- Stanford Medicine (US)
- Stanford Medical Center
- Venue
- Diabetes Technology & Therapeutics
- Publisher
- SAGE Publications
- Published
- 2014-01
- Volume
- 16
- Issue
- 1
- Pages
- 15-19
- ISSN
- 1520-9156 (ISSN-L)
- 1557-8593
- PMC
- PMC3887416
- OpenAlex
- W1972348237
- Cited by
- 90
- References
- 17
- Citations by year
- 2026: 2 · 2025: 2 · 2024: 8 · 2023: 8 · 2022: 15 · 2021: 10 · 2020: 5 · 2019: 6 · 2018: 5 · 2017: 6 · 2016: 11 · 2015: 8 · 2014: 4
- FWCI
- 6.04
- Type
- journal article
- Language
- en
- Open access
- green
- www.ncbi.nlm.nih.gov
- Locations
- Diabetes Technology & Therapeutics (publishedVersion)
- Europe PMC (PubMed Central) (publishedVersion)
- PubMed Central (publishedVersion)
- PubMed (publishedVersion)
- Funders
- Genentech
- 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
- Teflon catheter, insulin pump therapy, type 1 diabetes, continuous glucose monitoring, hyperglycemia, insulin requirement
- MeSH terms
- Adolescent, Adult, Blood Glucose, Catheterization, Child, Diabetes Mellitus, Type 1, Equipment Design, Female, Glycated Hemoglobin, Humans, Hyperglycemia, Hypoglycemic Agents, Infusions, Intravenous, Insulin, Male, Monitoring, Physiologic, Polytetrafluoroethylene, Steel, Time Factors, Blood Glucose Self-Monitoring, Body Mass Index, Cross-Over Studies
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