Severe Insulin Pump-Related Adverse Events: Potential Root Causes and Impact of the COVID-19 Pandemic
Authors' conclusion
Although insulin pumps are generally safe, SAEs related to their components and external factors can and do occur. By learning from the potential root causes of insulin pump-associated SAEs, providers and patients can implement corrective actions to prevent future events, thereby reducing harm.
Study context
- Population
- Reported insulin pump-associated severe adverse events (SAEs) involving intensive care unit (ICU) admissions and deaths, May 1, 2019 to January 31, 2021; MiniMed 670G, MiniMed 630G, Omnipod, Omnipod DASH and t:slim X2 pumps
- Outcome
- Insulin pump-associated SAEs reported to the Food and Drug Administration and potential root causes
- Follow-up
- 21-month measurement period
Methodological detailstemplate analysis of narrative data in reported SAEs
- Template analysis of narrative data in reported SAEs
Main finding
As reported in the abstract
SAEs involving an ICU admission
460
SAEs involving a death
288
Further findings
Impact of the COVID-19 pandemic
- Median monthly number of reported SAEs involving ICU admissions and deaths decreased during the pandemic; potential root causes unchanged
Original publication
Severe Insulin Pump-Related Adverse Events: Potential Root Causes and Impact of the COVID-19 Pandemic. J Diabetes Sci Technol. Published 28 May 2024. doi:10.
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