Bench-Side Dose Accuracy of an Open-Source Ultra-Low-Cost Insulin-Pump, With Testing Conducted to IEC 60601-2-24

Area of Science:

• Biomedical Engineering
• Medical Devices
• Diabetes Technology

Background:

• Rising global diabetes prevalence necessitates cost-effective management solutions.
• Significant treatment and indirect costs associated with diabetes impact individuals and healthcare systems.
• Health disparities in diabetes care highlight the need for accessible technologies.

Purpose of the Study:

• To present test results for an ultra-low-cost insulin pump prototype.
• To evaluate the accuracy and performance of a low-cost insulin pump against established standards.
• To assess the potential of affordable insulin pumps in improving diabetes care accessibility.

Main Methods:

• Development of an insulin pump using components with a bill of materials under $US100.
• Bench testing conducted in accordance with IEC60601-2-24 standards.
• Performance benchmarking against a commercially available insulin pump.

Main Results:

• The ultra-low-cost insulin pump achieved comparable accuracy to a commercial pump.
• Testing revealed an overall accuracy of 0.089% for the prototype pump.
• The prototype pump demonstrated a -0.392% accuracy in specific tests.
• Limited bench testing indicates accurate insulin delivery capabilities.

Conclusions:

• An ultra-low-cost insulin pump can accurately deliver insulin, showing promise for broader accessibility.
• Further testing in diverse environments is necessary to meet full IEC60601-2-24 compliance.
• This technology has the potential to mitigate health disparities in diabetes management.