Pediatric Use of Insulin Pump Technology: A Retrospective Study of Adverse Events in Children Ages 1–12 Years
Open accessAbstract
Background: Growing technological improvements in insulin pump design have increased the use of these devices in young children. To better understand the types of infusion pump-related problems and associated adverse events in this age group, we performed a comprehensive evaluation of pump-related adverse event reports received by the U.S. Food and Drug Administration (FDA) for children ages 1–12 years. Methods: A query was conducted of FDA's Manufacturer and User Facility Device Experience database from January 1, 1996, through December 31, 2009, in children ages 1–12 years involving insulin pumps. Report narratives were individually reviewed for age, gender, and seriousness of outcomes. Device or patient problems and potential contributory factors were assessed. Results: Over the past 14 years, 1774 (7%) of all insulin pump adverse event reports were identified in children ages 1–12. Of these reports, 777 (43%) resulted in hospitalization. In hospitalized cases ( n = 614), diabetic ketoacidosis and/or hyperglycemia were the predominant patient problems, and in other cases ( n = 98), hypoglycemia was evident. There were 106 emergency room visits, 19 cases requiring paramedic attention, and five deaths. The majority of reports indicated that the devices were not returned to the manufacturer, and root causes were not always confirmed. Conclusions: Younger children with diabetes deserve careful consideration of the risk and benefit of insulin pump technology. Studies are needed to better understand pediatric safety issues and to identify the root cause of adverse events. Problems related to patient education, device misuse, and malfunctions were found, highlighting the need to strengthen user training for children and their caregivers.
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Device labeling warns that at clinically relevant insulin infusion rates, especially at the low basal flow rates for pediatric users, the detection of occlusion may not occur until after the onset of DKA.
“Manufacturers are aware of the risks of SIND, and device labeling is replete with warnings that at clinically relevant insulin infusion rates, especially at the low basal flow rates for pediatric users, the detection of occlusion may not occur until after the onset of DKA [13].”
From Performance of a Continuous Subcutaneous Insulin Infusion (CSII) Pump With Acoustic Volume and Flow Sensing in Simulated High-Consequence Situations (2024) · cites this paper as [13]
The Introduction (page not provided) says pumps can have accuracy problems at lower volumes and that occlusion can cause serious adverse events. The Discussion (page not provided) links occlusion to DKA and notes that alarms do not always warn of leakage or dislodgment. Neither passage says device labeling warns that occlusion detection at low pediatric basal rates may occur only after DKA begins. (LLM, conf=0.83)
Experimental — accuracy not yet measuredDevice labeling warns that extreme care must be taken by the user to avoid introduction of air when filling the reservoir, and to be aware that outgassing of air can occur as insulin warms or when ambient pressure falls.
“The labeling also warns that extreme care must be taken by the user to avoid introduction of air when filling the reservoir, and to be aware that outgassing of air can occur as insulin warms (e.g., after refrigerated storage) or when ambient pressure falls (e.g., air travel).”
From Performance of a Continuous Subcutaneous Insulin Infusion (CSII) Pump With Acoustic Volume and Flow Sensing in Simulated High-Consequence Situations (2024) · cites this paper as [13]
The Introduction discusses pump reservoirs and priming problems, and the Discussion reports instances of incorrect priming, but neither gives the claimed device-labeling warning. Searches for air entering the reservoir, outgassing as insulin warms, and falling ambient pressure found no passage addressing those points. (LLM, conf=0.73)
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References 15 · Cited by 35
Research works printed but not linked: 10
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- Authors
- Cope, J. U., Samuels-Reid, J. H., & Morrison, A. E.
- Affiliations
- United States Food and Drug Administration (US)
- Division of Anesthesiology, General Hospital, Infection Control and Dental Devices, Office of Device Evaluation, Center for Devices and Radiological Health, Food and Drug Administration, Silver Spring, Maryland
- Corresponding author
- Cope, Judith U.
- ORCID
- Morrison, Audrey E.
- Venue
- Journal of Diabetes Science and Technology
- Publisher
- SAGE Publications
- Published
- 2012-09
- Volume
- 6
- Issue
- 5
- Pages
- 1053-1059
- ISSN
- 1932-2968 (ISSN-L)
- PMC
- PMC3570839
- OpenAlex
- W2147967737
- Cited by
- 35
- References
- 15
- Citations by year
- 2025: 1 · 2024: 2 · 2023: 1 · 2022: 1 · 2021: 2 · 2020: 4 · 2019: 4 · 2018: 5 · 2017: 3 · 2016: 4 · 2015: 5 · 2014: 1 · 2013: 2
- FWCI
- 2.05
- Type
- journal article
- Language
- en
- Open access
- bronze
- doi.org
- Locations
- Journal of Diabetes Science and Technology (publishedVersion)
- Europe PMC (PubMed Central) (publishedVersion)
- PubMed Central (publishedVersion)
- PubMed (publishedVersion)
- 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, pediatric diabetes, adverse events, device safety, diabetic ketoacidosis, hypoglycemia, hyperglycemia, hospitalization, equipment failure, patient education
- MeSH terms
- Age Factors, Child, Child, Preschool, Female, Hospitalization, Humans, Hyperglycemia, Hypoglycemic Agents, Infant, Insulin, Insulin Infusion Systems, Male, Pediatrics, Retrospective Studies, Diabetic Ketoacidosis, Drug-Related Side Effects and Adverse Reactions
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