Using Insulin Infusion Sets in CSII for Longer Than the Recommended Usage Time Leads to a High Risk for Adverse Events

Pfützner, Andreas; Sachsenheimer, Daniela; Grenningloh, Marco; Heschel, Matthias; Walther-Johannesen, Lene; Gharabli, Rabi; Klonoff, David C.

doi:10.1177/1932296815604438

Cited by 47 publications

(56 citation statements)

References 21 publications

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“…For benefit with a pump, patients need to be able to perform frequent monitoring of their glucose levels, bolus pre-meal [38] and change their infusion sets and cannula sites at regular intervals [39]. In this regard, technology is different from the use of a pharmacological intervention.…”

Section: Re-evaluationmentioning

confidence: 99%

“…In this regard, technology is different from the use of a pharmacological intervention. For benefit with a pump, patients need to be able to perform frequent monitoring of their glucose levels, bolus pre-meal [38] and change their infusion sets and cannula sites at regular intervals [39]. If they do not measure their glucose levels adequately, they are also at greater risk of diabetic ketoacidosis.…”

Section: Re-evaluationmentioning

confidence: 99%

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A Type 1 diabetes technology pathway: consensus statement for the use of technology in Type 1 diabetes

et al. 2019

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In both adults and children with diabetes, technologies such as continuous subcutaneous insulin infusion using insulin pumps and continuous glucose monitoring can help improve diabetes control, reduce hypoglycaemia and improve quality of life. Access to these technologies in the UK is very variable. Some technologies are recommended by the National Institute for Health and Care Excellence, while others have not been appraised, and new technologies are emerging all the time. Additionally, different guidelines for adults and children further complicate access to diabetes technology in the transition from paediatric to adult care. Against this background, Diabetes UK and NHS England have brought together a multidisciplinary group of experts, including clinicians and people with diabetes, to develop this consensus guideline, combining the different technologies into a common pathway to aid clinical and policy decisionmaking. We created a pathway that supports the incremental addition of technology as monotherapy and then dual therapy in the same way that we incrementally add in therapeutic agents to support people with Type 2 diabetes to achieve their personalized glycaemic targets. The pathway emphasizes the importance of structured education, specialist support and appropriate access to psychological therapies, as essential pillars for optimized use of diabetes-related technology, and recommends the re-evaluation of its use when the individual is unable either to use the technology appropriately or to achieve the intended outcomes. This pathway is endorsed by UK-wide clinical and patient associations and we recommend that providers and commissioners use it to ensure the right individual with diabetes has access to the right technology in a timely way to help achieve better outcomes.

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Section: Re-evaluationmentioning

confidence: 99%

Section: Re-evaluationmentioning

confidence: 99%

A Type 1 diabetes technology pathway: consensus statement for the use of technology in Type 1 diabetes

et al. 2019

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“…2 The authors are surprised by the absolute number of adverse events (AEs) recorded, and criticize our methodology of using poorly defined AE categories, nonvalidated AE questionnaires and having only a small number of participants. We appreciate the effort but would like to comment as follows:…”

Section: Letter To the Editormentioning

confidence: 99%

Longer Usage Time for CSII Catheters

Pfützner¹,

Sachsenheimer²,

Grenningloh³

2016

J Diabetes Sci Technol

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1 Ardilouze et al present a different way to analyze and interpret our results derived from a recent randomized prospective crossover study investigating the tolerability of 2-day use versus 4-day use of insulin infusion sets during continuous subcutaneous insulin infusion (CSII) treatment.2 The authors are surprised by the absolute number of adverse events (AEs) recorded, and criticize our methodology of using poorly defined AE categories, nonvalidated AE questionnaires and having only a small number of participants. We appreciate the effort but would like to comment as follows:1. The study has been conducted in accordance with all existing quality standards (good clinical practice [GCP], local regulatory and legal requirements, regular monitoring by external clinical research associates (CRAs) including source data validation, etc). So the results are what they are. We apologize that the outcome is not in line with the expectations of health care professionals, who are in great favor of CSII as a treatment option. It is well known that studies specifically targeting adverse events as a primary endpoint result in higher AE frequencies than studies with clinical endpoints, where AEs are collected only in the process of the routine visits. In our opinion, our study does not even discredit CSII as the most optimal treatment option for insulin-treated patients with diabetes, but provides a real-world insight into the number of issues occurring in daily practice. Our way to categories the AEs and our standardized questionnaires are not validated, because there is no precedent research existing. They should preferably be understood a first suggestion for future validations. Unfortunately, we are not aware about any other study conducted yet with similar design, and we hope that our publication may trigger further research on this topic. 2. We respectfully disagree to the notion, that our sample size was too small for the purpose. In the absence of alternative studies, we used a pilot study, which we performed several years ago, where patients were using their catheters for steadily increasing periods of time (ie, 1 day, 2 days, etc) until skin problems started to occur. 3 In that prior study, the problems started to occur on day 3. According to the power analysis based on these pilot findings, the number of patients for this study to see a statistically significant difference at a power level of 80% with a first order error of 5 % was as small as 12.6 for the crossover design. By enrolling 24 subjects, we tried to accommodate the expectation of preferably larger cohorts to come to an at least acceptable number. However, a larger number was clearly not necessary to confirm the study hypothesis, because of the size of the negative effect of prolonged catheter use on treatment tolerability in the majority of the study participants. 3. We agree to the point that frequent catheter replacement every second day is more expensive. We would like to emphasize, however, that next to the higher frequency of AEs, a prolonged use ...

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“…According to the authors, these data support the 2-to 3-day replacement recommendation; authors also expressed doubts on the economic benefits of longer KT wear. 1 It seems to us that the Pfützner study data can be interpreted differently. In this type of study, AE frequency is the main issue.…”

Section: Letter To the Editormentioning

confidence: 99%