Insulin Infusion Set: The Achilles Heel of Continuous Subcutaneous Insulin Infusion

Heinemann, Lutz; Krinelke, Lars

doi:10.1177/193229681200600429

Cited by 132 publications

(149 citation statements)

References 64 publications

Supporting

Mentioning

144

Contrasting

Unclassified

Order By: Relevance

“…1 The first involved an 11-year-old female who developed toxic shock syndrome from a Staphylococcus aureus infection after leaving her infusion set in for up to 10 days. 21 Another was a case of death due to bacterial endocarditis that started at the site of infusion set insertion.…”

Section: Discussionmentioning

confidence: 99%

See 1 more Smart Citation

Duration of Infusion Set Survival in Lipohypertrophy Versus Nonlipohypertrophied Tissue in Patients with Type 1 Diabetes

Karlin

Pyle

et al. 2016

Diabetes Technology & Therapeutics

View full text Add to dashboard Cite

Background: Improved insulin infusion set survival and faster insulin action are important issues for pump users and for the development of an artificial pancreas. The current recommendation is to change infusion sets every 3 days. Our objectives were to determine the effect of lipohypertrophy (LH) on infusion set survival and continuous glucose monitoring glucose levels. Research Design and Methods: In this multicenter crossover trial, we recruited 20 subjects (age 28.1 -9.0 years) with type 1 diabetes (duration 17.5 -8.8 years) and an area of lipohypertrophied tissue >3 cm. Subjects alternated weekly wearing a Teflon infusion set in an area of either LH or non-LH for 4 weeks. Sets were changed after (a) failure or (b) surviving 7 days of use. Results: The least-squares mean duration of infusion set survival for sets that lasted <7 days in lipohypertrophied tissue was 4.31 days compared with 4.12 days in nonlipohypertrophied tissue (P = 0.71). The average duration of set survival for individual subjects ranged from 2.2 to 7.0 days. Infusion sets in lipohypertrophied tissue failed due to hyperglycemia in 35% of subjects compared with 23% in nonlipohypertrophied tissue (P = 0.22). Both lipohypertrophied and nonlipohypertrophied tissues displayed a general increase in mean daily glucose after the third day of infusion set wear, but daily mean glucose did not differ by tissue type (P > 0.38 on each day). Conclusion: LH did not significantly affect infusion set survival or mean glucose. Achieving optimal infusion set performance requires research into factors affecting set survival. Additionally, the recommendation for duration of set change may need to be individualized.

show abstract

Section: Discussionmentioning

confidence: 99%

“…1 One problem for closed-loop insulin delivery is the limited life span of continuous subcutaneous insulin infusion sets, and the current recommendation is to change the infusion site every 3 days. 1 Evidence about factors that affect infusion set survival is needed to extend infusion site life span.…”

mentioning

confidence: 99%

Duration of Infusion Set Survival in Lipohypertrophy Versus Nonlipohypertrophied Tissue in Patients with Type 1 Diabetes

Karlin

Pyle

et al. 2016

Diabetes Technology & Therapeutics

View full text Add to dashboard Cite

show abstract

“…Infection was the most common issue reported in older studies [8,31,32]. Earliest reported data showed that 29 % of patients experienced an infected infusion site at some point, most commonly presenting as cellulitis [8].…”

Section: Infectionmentioning

confidence: 95%

Clinical review: insulin pump-associated adverse events in adults and children

et al. 2015

View full text Add to dashboard Cite

This timely review covers all potential insulin pump-associated adverse events, including their incidence, features, impacts, and contributory factors such as the pump user. The importance of ongoing anticipatory education and support for patients and families using this intensive insulin technology is highlighted, which if done well should improve the overall experience of pump therapy for users, and hopefully reduce the incidence and impact of severe adverse events.

show abstract

“…However, IIS issues have led to the greatest number of recalls by the FDA in the USA (see above). The pump and the IIS should be considered as parts of a system, rather than as individual components [21]. However, this is not currently the case, as some IISs are cleared as part of the pump system under different product codes and some are cleared as a separate device product code.…”

Section: Insulin Infusion Setsmentioning

confidence: 99%

Insulin pump risks and benefits: a clinical appraisal of pump safety standards, adverse event reporting and research needs. A Joint Statement of the European Association for the Study of Diabetes and the American Diabetes Association Diabetes Technology Working Group

Fleming²,

et al. 2015

Self Cite

View full text Add to dashboard Cite

Insulin pump therapy, also known as continuous subcutaneous insulin infusion (CSII), is an important and evolving form of insulin delivery, which is mainly used for people with type 1 diabetes. However, even with modern insulin pumps, errors of insulin infusion can occur due to pump failure, insulin infusion set (IIS) blockage, infusion site problems, insulin stability issues, user error or a combination of these. Users are therefore exposed to significant and potentially fatal hazards: interruption of insulin infusion can result in hyperglycaemia and ketoacidosis; conversely, delivery of excessive insulin can cause severe hypoglycaemia. Nevertheless, the available evidence on the safety and efficacy of CSII remains limited. The European Association for the Study of Diabetes (EASD) and American Diabetes Association (ADA) have therefore joined forces to review the systems in place for evaluating the safety of pumps from a clinical perspective. We found that useful information held by the manufacturing companies is not currently shared in a sufficiently transparent manner. Public availability of adverse event (AE) reports on the US Food and Drug Administration's Manufacturer and User Facility Device Experience (MAUDE) database is potentially a rich source of safety information but is insufficiently utilised due to the current configuration of the system; the comparable database in Europe (European Databank on Medical Devices, EUDAMED) is not publicly accessible. Many AEs appear to be attributable to human factors and/or user error, but the extent to which manufacturing companies are required by regulators to consider the interactions of users with the technical features of their products is limited. The clinical studies required by regulators prior to marketing are small and over-reliant on bench testing in relation to 'predicate' products. Once a pump is available on the market, insufficient data are made publicly available on its long-term use in a real-world setting; such data could provide vital information Diabetologia (2015) 58:862-870 DOI 10.1007 to help healthcare teams to educate and support users, and thereby prevent AEs. As well as requiring more from the manufacturing companies, we call for public funding of more research addressing clinically important questions in relation to pump therapy: both observational studies and clinical trials. At present there are significant differences in the regulatory systems between the USA and European Union at both preand post-marketing stages; improvements in the European system are more urgently required. This statement concludes with a series of recommended specific actions for 'meknovigilance' (i.e. a standardised safety approach to technology) which could be implemented to address the shortcomings we highlight.

show abstract

Insulin Infusion Set: The Achilles Heel of Continuous Subcutaneous Insulin Infusion

Cited by 132 publications

References 64 publications

Duration of Infusion Set Survival in Lipohypertrophy Versus Nonlipohypertrophied Tissue in Patients with Type 1 Diabetes

Duration of Infusion Set Survival in Lipohypertrophy Versus Nonlipohypertrophied Tissue in Patients with Type 1 Diabetes

Clinical review: insulin pump-associated adverse events in adults and children

Insulin pump risks and benefits: a clinical appraisal of pump safety standards, adverse event reporting and research needs. A Joint Statement of the European Association for the Study of Diabetes and the American Diabetes Association Diabetes Technology Working Group

Contact Info

Product

Resources

About