Alek Karagozyan, Sujata K. Bhatia

Abstract: The Centers for Disease Control and Prevention (CDC) reports that 23.4 million people in the US were diagnosed with diabetes in 2015. Further, the National Diabetes Statistics Report for 2020 states that cases of diabetes have risen to 34.2 million, with 1.5 million new cases annually. Another alarming trend is the rise in insulin costs, making it difficult for many Americans to afford treatment. The American Journal of Managed Care indicates that the price for a vial of insulin rocketed from $21 in 1996 to $275 in 2019, which appears to be a crisis in the making. In relation to these trends, this research tracks adverse event reports for insulin and insulin pumps. The FDA Adverse Event Reporting System (FAERS) database reveals that adverse event reports for insulin from 2018 to 2021 show a steady decrease in the number of incidents. Similarly, the FDA Manufacturer and User Facility Device Experience (MAUDE) database indicates a decrease in incident reports for common insulin pumps within the same time period. There are two possible explanations for this counterintuitive trend. Since it is highly unlikely based on the data that there are fewer diabetics using insulin, there could be a decrease of usage based on the economics of acquiring insulin and related devices. The other possible explanation is that the advent and rapid adoption of continuous glucose monitoring devices has allowed patients to better regulate their insulin intake, leading to lower levels of usage. Further studies will be needed to determine root causes of these trends.

Keywords: diabetes, insulin, continuous glucose monitoring, insulin pump, adverse events

Date Published: September 1, 2022
DOI: 10.11159/jbeb.2022.002

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