Insulin Pump-Associated Adverse Events: A Qualitative Descriptive Study of Clinical Consequences and Potential Root Causes

Estock, Jamie L.; Codario, Ronald A.; Keddem, Shimrit; Zupa, Margaret; Rodriguez, Keri L.; DiNardo, Monica

doi:10.1089/dia.2022.0498

Cited by 4 publications

(1 citation statement)

References 32 publications

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“…These investigations utilized data from the FDA Manufacturer and User Facility Device Experience (MAUDE) database. Out of the 2,429 AEs reported, approximately 8% were linked to issues with the infusion set or site ( 26 ).…”

Section: Introductionmentioning

confidence: 99%

Insulin infusion sets associated with adverse events: strategies for improved diabetes education

Neves,

Martins,

Gabbay

et al. 2023

Front. Med.

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IntroductionInsulin Infusion Sets (IIS) play a crucial role in ensuring the safe delivery of insulin through a Continuous Subcutaneous Insulin Infusion (CSII) for individuals with Type 1 Diabetes (T1D). Recent advancements in therapy have highlighted the need to address issues such as unexplained hyperglycemia and IIS occlusion.ObjectiveTo investigate the adverse events (AEs) associated with IIS that impact the treatment of T1D, with a specific focus on promoting effective educational practices.MethodsOne hundred and eighteen patients under treatment at the Diabetes Center Insulin Pump Ambulatory, Federal University of São Paulo responded to a semi-structured questionnaire. Over 6 months, a nurse researcher interviewed them via video calls.ResultsCatheter-related adverse events (AEs) included catheter knots, folding, and accidental traction. AEs associated with cannula use were mainly related to cannula fixation adhesive, insulin leakage, bleeding episodes, and skin problems. The cannula patch tends to detach easily in hot conditions or when used for more than 3 days, leading to local itching. Adhesive glue can cause redness and pain. Insulin leakage typically occurs after the catheter disconnects from the cannula, accidental cannula traction, or beneath the cannula patch. Bleeding has been reported inside the cannula or at the insertion site, resulting in local pain and, in some cases, obstruction of insulin flow. When accidental cannula traction occurs, it is recommended to replace the entire IIS system. In situations involving bleeding, leakage, insulin odor, or unsuccessful attempts to correct hyperglycemic episodes with a “bolus” of insulin, it is advisable to change the IIS system and evaluate appropriate techniques for handling and infusing the device. Moreover, regular inspections of the device and reservoir/cartridge are essential.ConclusionSerious AEs can occur even in cases where the occlusion alarm is not activated, leading to interruptions in insulin flow. Conversely, in less severe situations, alarm activation can occur even in the absence of insulin flow interruption. Accidental catheter traction and catheter bending are commonly encountered in everyday situations, while issues related to the cannula directly affect blood glucose levels. AEs related to the IIS cannula often involve insulin leakage into the skin, bleeding, and skin events attributed to adhesive issues with the cannula.

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Section: Introductionmentioning

confidence: 99%

Insulin infusion sets associated with adverse events: strategies for improved diabetes education

Neves,

Martins,

Gabbay

et al. 2023

Front. Med.

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Insulin Pump Alarms During Adverse Events: A Qualitative Descriptive Study

Estock,

Codario,

Zupa

et al. 2023

J Diabetes Sci Technol

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Objective: Explore alarm signals cited in insulin pump-associated adverse events (AEs), describe the clinical consequences and other root cause informing remarks that cooccurred with the alarm signals, and identify opportunities for improvements to patient education, instructional materials, and alarm systems to prevent future AEs. Research Design and Methods: We explored the type, frequency, and associated clinical consequences of alarm signals cited in a pre-coded data set of 2294 insulin pump-associated AEs involving the MiniMed 670G, MiniMed 630G, and t:slim X2. We also explored the clinical consequences and other root cause informing remarks that cooccurred with the top 10 most frequently cited alarm signals. Results: Overall, 403 AEs narratives cited at least one alarm signal. Of the 40 unique alarm signals cited, 42.5% were “alarms,” 25.0% were “alerts,” and 32.5% were not referenced in the instructional materials packaged with the corresponding pump. The top 10 most frequently cited alarm signals included two obstruction of flow alarms, which accounted for 49.9% of all AEs citing at least one alarm, and two unreferenced alarms. The most frequent cooccurring root cause informing remark varied across the top 10 alarm signals and revealed valuable insight into why these alarms may have occurred. Conclusions: Our findings demonstrate the value of analyzing alarm signals cited in insulin pump-associated AEs and reveal multiple opportunities for providers to educate patients on how to respond to alarm signals and manage their pumps to avoid AEs, and for insulin pump manufacturers to update instructional materials and improve alarm systems to support appropriate patient response.

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Severe Insulin Pump-Related Adverse Events: Potential Root Causes and Impact of the COVID-19 Pandemic

Orbell,

Codario,

Zupa

et al. 2024

J Diabetes Sci Technol

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Objective: To explore insulin pump-associated severe adverse events (SAEs) involving intensive care unit (ICU) admissions and deaths and examine the impact of the COVID-19 pandemic on these SAEs. Methods: Qualitative template analysis of narrative data in reported insulin pump-associated SAEs occurring between May 1, 2019, and January 31, 2021, involving MiniMed 670G, MiniMed 630G, Omnipod, Omnipod DASH, and t:slim X2 insulin pumps. Results: Over the 21-month measurement period, 460 SAEs involving an ICU admission and 288 SAEs involving a death were reported to the Food and Drug Administration. Problems with the pump or pod reservoir/cartridge were among the most frequently cited potential root causes in SAEs involving ICU admissions and deaths overall. However, problems with the infusion set or site and the pump battery or power emerged in the top three potential root causes of SAEs involving an ICU admission, whereas the patient sleeping at the time of the event and the tasks of changing the pod/infusion set, including reservoir/cartridge and programming the pump emerged in the top three for SAEs involving a death. The median monthly number of reported SAEs involving ICU admissions and deaths decreased during the pandemic, but their potential root causes were unchanged. Conclusions: 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.

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Insulin Pump-Associated Adverse Events: A Qualitative Descriptive Study of Clinical Consequences and Potential Root Causes

Cited by 4 publications

References 32 publications

Insulin infusion sets associated with adverse events: strategies for improved diabetes education

Insulin infusion sets associated with adverse events: strategies for improved diabetes education

Insulin Pump Alarms During Adverse Events: A Qualitative Descriptive Study

Severe Insulin Pump-Related Adverse Events: Potential Root Causes and Impact of the COVID-19 Pandemic

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