Accuracy of a Low-Cost Continuous Subcutaneous Insulin Infusion Pump Prototype: In Vitro Study Using Combined...

Area of Science:

• Biomedical Engineering
• Medical Devices
• Diabetes Technology

Background:

• Infusion devices are critical for patient safety.
• Accurate insulin delivery is essential for managing type 1 diabetes.
• Existing continuous insulin infusion pumps can be costly.

Purpose of the Study:

• To evaluate the infusion accuracy and precision of a novel low-cost insulin infusion pump prototype.
• To assess the suitability of the prototype for type 1 diabetic patients in resource-limited settings.

Main Methods:

• Utilized a microgravimetric method adapted from IEC60601-2-24 for accuracy assessment.
• Estimated syringe plunger displacement to evaluate infusion precision.
• Conducted in vitro tests to compare performance with commercial pumps.

Main Results:

• The low-cost prototype demonstrated good accuracy with an average error of 2.2%.
• 42.50% of infusions were within ±5% accuracy, and 84.17% were within ±15%.
• The device showed satisfactory performance, comparable to commercial insulin pumps.

Conclusions:

• The developed prototype is a functional, compact, and accurate low-cost insulin infusion device.
• The results suggest its potential as an affordable option for type 1 diabetes management in Brazil and other developing countries.
• The miniaturized mechanical system exhibited good functionality, precision, and accuracy in repeatability tests.