Insulin pump failures are still frequent: a prospective study over 6 years from 2001 to 2007

Guilhem, Isabelle; Balkau, Beverley; Lecordier, F.; Malécot, Jean-François; Elbadii, S.; Leguerrier, Alain; Poirier, Jean-Yves; Derrien, C.; Bonnet, Fabrice

doi:10.1007/s00125-009-1549-7

Cited by 45 publications

(40 citation statements)

References 6 publications

Supporting

Mentioning

Contrasting

Order By: Relevance

“…Our finding of 48% of subjects having any pump malfunction compares with 36% breakdown of the pumps issued to patients in the study of Guilhem et al 9 This somewhat higher figure might reflect a different mix of pump manufacturers and models. Also, some of the reported problems might be misinterpretations by patients and thus reflect inexperience in the first year of therapy, although presumably this does not apply to the most frequent problems of ''no delivery'' or keypad malfunction.…”

Section: Discussioncontrasting

confidence: 56%

“…are similar to those described by others. 8,9 We also found that infusion set kinking and blockage were very common-about 10% of patients had a frequent problem with either or both. It is possible that some patients misinterpreted blocking as kinking, and vice versa, because early blockage is often caused by kinking and late blockage by insulin aggregation/precipitation.…”

Section: Discussionmentioning

confidence: 78%

“…8 Complications of CSII may have changed in the last 25 years because of improvements and increasing sophistication in technology and clinical care; this should ideally reduce risks, but it may possibly exacerbate problems or introduce new ones. In the last decade or so, Guilhem et al 9 reported on insulin pump failures recorded in France from 2001 to 2007, and Cope et al 10 discussed adverse insulin pump events in adolescents reported to the Food and Drug Administration from 1996 to 2005. Dermatological complications at the infusion site with CSII have also been described.…”

Section: Introductionmentioning

confidence: 99%

See 2 more Smart Citations

Nonmetabolic Complications of Continuous Subcutaneous Insulin Infusion: A Patient Survey

Pickup

Yemane

Brackenridge

et al. 2014

Diabetes Technology & Therapeutics

113

View full text Add to dashboard Cite

Background: Little is known about the frequencies and types of nonmetabolic complications occurring in type 1 diabetes patients being treated by modern insulin pump therapy (continuous subcutaneous insulin infusion [CSII]), when recorded by standardized questionnaire rather than clinical experience. Subjects and Methods: A self-report questionnaire was completed by successive subjects with type 1 diabetes attending an insulin pump clinic, and those with a duration of CSII of ‡ 6 months were selected for analysis (n = 92). Questions included pump manufacturer, insulin, infusion set type and duration of use, frequency of infusion set and site problems, pump malfunctions, and patient-related problems such as weight change since starting CSII. Results: Median (range) duration of CSII was 3.3 (0.5-32.0) years, and mean -SD duration of infusion set use was 3.2 -0.7 (range 2-6) days. The commonest infusion set problems were kinking (64.1% of subjects) and blockage (54.3%). Blockage was associated with > 3 days of use of infusion sets plus lispro insulin in the pump (relative risk [95% confidence interval], 1.71 [1.03-2.85]; P = 0.07). The commonest infusion site problem was lipohypertrophy (26.1%), which occurred more often in those with long duration of CSII (4.8 [2.38-9.45] vs. 3.0 [1.50-4.25] years; P = 0.01). Pump malfunction had occurred in 48% of subjects (43% in the first year of CSII), with ''no delivery,'' keypad, and battery problems commonly occurring. Although some patients reported weight gain (34%) and some weight loss (15%) on CSII, most patients (51%) reported no change in weight. Conclusions: Pump, infusion set, and infusion site problems remain common with CSII, even with contemporary technology.

show abstract

Section: Discussioncontrasting

confidence: 56%

Section: Discussionmentioning

confidence: 78%

Section: Introductionmentioning

confidence: 99%

See 1 more Smart Citation

Nonmetabolic Complications of Continuous Subcutaneous Insulin Infusion: A Patient Survey

Pickup

Yemane

Brackenridge

et al. 2014

Diabetes Technology & Therapeutics

113

View full text Add to dashboard Cite

show abstract

“…Results from unselected cases from these cohorts might differ from those of clinical trials. In one survey of 640 new pumps from four different insulin pump manufacturers, 36% were reported to have a defect of some sort including 16% which had failed and 6.5% which required replacement due to a mechanical defect [27,28]. To date, registries have focused on collecting data on metabolic control, but they should be encouraged to include a wider range of items in their databases, covering-among other aspects-AEs with insulin pumps.…”

Section: Education and Trainingmentioning

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

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

“…Hardware and software errors including autocalculation of bolus doses that may lead to overmedication or undermedication. Human or manufacturing errors in refilling the pump or changes in dosage, concentration, or type of insulin infused are all opportunities for pump-related drug error [8,9]. The feared "run-away pump" that delivers a large insulin overdose has been reported, but appears to be exceptionally rare [10][11][12].…”

Section: What Are the Advantages And Risks Of Insulin Pump Therapy?mentioning

confidence: 99%

Case Files of the Harvard Medical Toxicology Fellowship at Children’s Hospital Boston: An Insulin Overdose

Skolnik

Ewald

2010

J. Med. Toxicol.

View full text Add to dashboard Cite

A 16-year-old boy with a history of type I diabetes mellitus being managed with an insulin pump presented to the emergency department in cardiac arrest. Per report from the patient's mother, the patient had noticed that his insulin cartridge, containing insulin lispro, was empty the night prior to admission so he had replaced it at approximately 7:00 PM. He had used his glucometer through the night with recorded values of 225-389 mg/dL and had administered a total of 14.5 units of insulin via his pump. At around 6:30 AM, the morning of admission, his mother attempted to wake him for school and found him cyanotic and motionless. She attempted to obtain a fingerstick glucose measurement but was unable to do so and administered glucagon, as well as activating Emergency Medical Services (EMS). When EMS arrived, the patient was pulseless. Cardiopulmonary resuscitation was initiated, and the patient was endotracheally intubated. Point-of-care glucose determination was 81 mg/dL. He received epinephrine, atropine, naloxone, and an ampule of 50% dextrose (25 g) during his prehospital care. He was defibrillated twice at 200 J for ventricular fibrillation. He was transferred to the emergency department with cardiopulmonary resuscitation in progress. EMS reported that an empty insulin syringe had been seen underneath the patient's bed. After approximately 1 h of resuscitative efforts, during which the patient received additional epinephrine, sodium bicarbonate, and hydrocortisone, he had return of spontaneous circulation. His initial arterial blood gas revealed a pH of 6.8, PaCO 2 of 70 mmHg, and PaO 2 of 335 mmHg. His serum glucose at that time was 377 mg/dL, and the anion gap was 39 mEq/L with urine negative for ketones. He underwent computed tomography scan of the head, chest, abdomen, and pelvis that demonstrated left upper lobe consolidation and gastric distention but was otherwise normal. He was transferred to a tertiary-care children's hospital where his serum glucose on arrival was 50 mg/dL. He received 25 g of intravenous dextrose, and an infusion of 10% dextrose in normal saline was started. A toxicology consult was obtained.

show abstract

Insulin pump failures are still frequent: a prospective study over 6 years from 2001 to 2007

Cited by 45 publications

References 6 publications

Nonmetabolic Complications of Continuous Subcutaneous Insulin Infusion: A Patient Survey

Nonmetabolic Complications of Continuous Subcutaneous Insulin Infusion: A Patient Survey

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

Case Files of the Harvard Medical Toxicology Fellowship at Children’s Hospital Boston: An Insulin Overdose

Contact Info

Product

Resources

About