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Cited by 53Diabetes Management and ResearchIntravenous Infusion Technology and SafetyPatient Safety and Medication Errors

Consequences of delayed pump infusion line change in patients with type 1 diabetes mellitus treated with continuous subcutaneous insulin infusion

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Thethi, Tina K., Rao, Ajay, Kawji, Haytham, Mallik, Tilak, Yau, C. Lillian, Christians, Uwe, Fonseca, Vivian·2010·Journal of Diabetes and its Complications
DOI 10.1016/j.jdiacomp.2009.03.002PMC PMC2854665
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Abstract

Objective To systematically investigate the effect of lack of adherence to the recommended change in insulin pump infusion line use beyond 48 h and determine whether the type of insulin made a difference. Research design and methods This was a double-blind, randomized, crossover trial with 20 patients with diabetes mellitus I using insulins aspart and lispro without a line change for up to 100 h. Using retrospective continuous glucose monitoring, we analyzed the average glucose over the day. Changes in serum 1,5-anhydroglucitol, carboxymethyllysine, and free 15-F(2t) isoprostane were also studied. Results From Day 2 to Day 5 of the pump line use, the daily average glucose level increased from 122.7 to 163.9 mg/dl (P<.05), fasting glucose from 120.3 to 154.5 mg/dl (P<.05), postprandial glucose from 114.6 to 172.1 mg/dl (P<.05), and the daily maximum glucose from 207.7 to 242.8 dl (P<.05 for the trend). Time period that the glucose was >180 mg/dl increased from 14.5% to 38.3% (P<.05). Loss of control occurred despite increase in total daily insulin dose from 48.5+/-11.8 to 55.3+/-17.9 U (P=.05). There was no difference in loss of control between insulin types, and biomarkers measured did not change significantly. Conclusions The insulin pump infusion should be changed every 48 h in patients using continuous subcutaneous insulin infusion (CSII), to avoid loss of glycemic control. In the short-term, this loss of glycemic control has no impact on oxidative stress and glycation.

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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 [12]

    The Results and Conclusions (pages unavailable) report worsening glycemic control as infusion-line use continued beyond 48 hours, including more time with glucose above 180 mg/dL. They do not establish an increase in events defined by blood glucose above 250 mg/dL, site reactions, or silent occlusions with wear beyond three days. The Introduction mentions an infusion-site infection in an earlier case, but not an observed increase in site reactions in this study. (LLM, conf=0.88)

    Experimental — accuracy not yet measured

  • Silent 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 [18]

    The Conclusions report that glycemic control deteriorated after 48 hours of pump infusion line use, with increases in several glucose measures, and discuss a possible effect on glucose variability. They do not identify silent occlusions as the cause or characterize the hyperglycemia as unexplained; the mention of catheter occlusions concerns a separate study. (LLM, conf=0.84)

    Experimental — accuracy not yet measured

  • 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 [3]

    The Results report significantly increased glucose levels and time spent above 180 mg/dL as pump infusion lines were worn from day 2 to day 5. The paper does not report significant mechanical problems with the infusion sets during its own trial; its Conclusions mention only a nonsignificant trend toward fewer catheter occlusions in another study. Thus it supports the prolonged-wear hyperglycemia finding, but not the full description of significant device-related events. (LLM, conf=0.85)

    Experimental — accuracy not yet measured

  • 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 [3]

    The Conclusions (page unavailable) report that glycemic control deteriorated after 48 hours of pump infusion line use. The Introduction (page unavailable) describes a serious infusion-site infection after prolonged wear, but attributes it to an earlier case report; this study does not demonstrate significant IIS- or site-related adverse events of its own. (LLM, conf=0.85)

    Experimental — accuracy not yet measured

  • 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 [3]

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References 31 · Cited by 53

Research works printed but not linked: 27

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Authors
Thethi, T. K., Rao, A., Kawji, H., Mallik, T., Yau, C. L., Christians, U., & Fonseca, V.
Affiliations
  • Tulane University (US)
  • University of Colorado Denver (US)
Corresponding author
Thethi, Tina K.
ORCID
Venue
Journal of Diabetes and its Complications
Publisher
Elsevier BV
Published
2010-03
Volume
24
Issue
2
Pages
73-78
ISSN
  • 0891-6632 (ISSN-L)
  • 1056-8727
DOI
10.1016/j.jdiacomp.2009.03.002
PMC
PMC2854665
OpenAlex
W2038371745
Cited by
53
References
31
Citations by year
2025: 2 · 2024: 2 · 2023: 10 · 2022: 5 · 2021: 3 · 2020: 3 · 2019: 2 · 2018: 4 · 2017: 1 · 2016: 4 · 2015: 7 · 2014: 2 · 2013: 4 · 2012: 3
FWCI
0.97
Type
journal article
Language
en
Open access
Licence
www.elsevier.com/tdm/userlicense/1.0/ (tdm)
Locations
  • Journal of Diabetes and its Complications (publishedVersion)
  • PubMed (publishedVersion)
  • PubMed Central (acceptedVersion)
Funders
  • National Heart, Lung, and Blood Institute (T32HL007609)
  • National Institute of Diabetes and Digestive and Kidney Diseases (P30DK048520)
  • National Center for Research Resources (M01RR005096, M01RR000827)
  • Eunice Kennedy Shriver National Institute of Child Health and Human Development (K12HD043451)
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
type 1 diabetes, insulin pump therapy, insulin aspart, insulin lispro, glycemic control, hyperglycemia, oxidative stress, glycation, 1,5-anhydroglucitol, carboxymethyllysine, isoprostanes, continuous glucose monitoring
MeSH terms
Adolescent, Adult, Aged, Blood Glucose, Deoxyglucose, Diabetes Mellitus, Type 1, Double-Blind Method, Fasting, Female, Humans, Hyperglycemia, Insulin, Insulin Infusion Systems, Lysine, Male, Middle Aged, Cross-Over Studies, F2-Isoprostanes, Infusions, Subcutaneous, Young Adult, Insulin Lispro

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