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Cited by 143Diabetes Management and ResearchPatient Safety and Medication ErrorsIntravenous Infusion Technology and Safety

Insulin Pump Risks and Benefits: A Clinical Appraisal of Pump Safety Standards, Adverse Event Reporting, and Research Needs

Heinemann, Lutz, Fleming, G. Alexander, Petrie, John R., Holl, Reinhard W., Bergenstal, Richard M., Peters, Anne L.·2015·Diabetes Care
DOI 10.2337/dc15-0168
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Abstract

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 hyperglycemia and ketoacidosis; conversely, delivery of excessive insulin can cause severe hypoglycemia. Nevertheless, the available evidence on the safety and efficacy of CSII remains limited. The European Association for the Study of Diabetes (EASD) and the 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 utilized 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 ap…

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Crossref · 10.2337/dc15-0168

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  • Resolution of occlusions may result in insulin surges, increasing the risk of severe hypoglycemia.

    “Conversely, the resolution of occlusions may result in insulin surges, increasing the risk of severe hypoglycemia.22”

    From Clinical utility of the twiist Automated Insulin Delivery System: first study with twiist (2026) · cites this paper as [22]

  • The American Diabetes Association and the European Association for the Study of Diabetes issued a joint statement contrasting the paucity of publications related to IISs and insulin flow blockage with the large number of IIS-related adverse events on the FDA MAUDE database.

    “Recently, the American Diabetes Association and the European Association for the Study of Diabetes issued a joint statement on insulin pump benefits and risks, in which the paucity of publications related to IISs and insulin flow blockage was contrasted with the large number of IIS-related adverse events on the Food and Drug Administration MAUDE database.8”

    From Reduced Silent Occlusions with a Novel Catheter Infusion Set (BD FlowSmart): Results from Two Open-Label Comparative Studies (2016) · cites this paper as [8]

  • Patient surveys indicate considerable variation in the actual frequency with which patients exchange infusion sets, with mean change intervals ranging from 2.7 to 4.8 days and a range from 1 to 30 days.

    “but patient surveys indicate that there is considerable variation in the actual frequency with which patients exchange infusion sets, with mean change intervals ranging from 2.7 to 4.8 days with a range from 1 to 30 days. 33”

    From Real-Time Detection of Infusion Site Failures in a Closed-Loop Artificial Pancreas (2018) · cites this paper as [33]

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Authors
Heinemann, L., Fleming, G. A., Petrie, J. R., Holl, R. W., Bergenstal, R. M., & Peters, A. L.
Affiliations
  • Science & Co, Düsseldorf, Germany
  • Kinexum, Harpers Ferry, WV
  • University of Glasgow (GB)
  • Universität Ulm (DE)
  • Park Nicollet Health Services (US)
  • University of Southern California (US)
Corresponding author
Petrie, John R.
ORCID
Venue
Diabetes Care
Publisher
American Diabetes Association
Published
2015-03-16
Volume
38
Issue
4
Pages
716-722
ISSN
  • 0149-5992 (ISSN-L)
  • 1935-5548
DOI
10.2337/dc15-0168
OpenAlex
W2165308700
Cited by
143
References
2
Citations by year
2026: 8 · 2025: 7 · 2024: 10 · 2023: 12 · 2022: 9 · 2021: 14 · 2020: 12 · 2019: 18 · 2018: 19 · 2017: 12 · 2016: 11 · 2015: 11
FWCI
15.33
Type
journal article
Language
en
Open access
closed
Locations
  • Diabetes Care (publishedVersion)
  • PubMed (publishedVersion)
  • ENLIGHTEN (Jurnal Bimbingan dan Konseling Islam) (submittedVersion)
Topics
  • Health Sciences › Medicine › Endocrinology, Diabetes and Metabolism › Diabetes Management and Research
  • Health Sciences › Health Professions › Emergency Medical Services › Patient Safety and Medication Errors
  • Physical Sciences › Engineering › Biomedical Engineering › Intravenous Infusion Technology and Safety
Keywords
insulin pump therapy, type 1 diabetes, adverse event reporting, MAUDE database, medical device regulation, user errors, hypoglycemia, hyperglycemia, ketoacidosis, post-marketing surveillance
MeSH terms
Diabetes Mellitus, Type 1, Equipment Failure, Europe, Humans, Hyperglycemia, Hypoglycemia, Insulin, Insulin Infusion Systems, United States, Adverse Drug Reaction Reporting Systems, Risk Assessment, Device Approval, Medical Device Recalls

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