Study of insulin infusion in diabetic rats with an ultra-low-cost insulin pump for managing blood glucose levels

Introduction

This study assesses the accuracy of an ultra-low-cost insulin pump for regulating blood glucose, an essential component of the artificial pancreas.

Objectives

The primary objective is to assess the accuracy of blood glucose regulation using an ultra-low-cost insulin pump compared with insulin injections.

Methods

The study was conducted using 14 male Wistar rats aged 14 weeks, which were induced with diabetes through a streptozotocin procedure. The control group (seven subjects) was treated with subcutaneous insulin injections, and the study group (seven subjects) was treated with the experimental insulin pump.

Results

Our findings reveal that the ultra-low-cost insulin pump performs comparably to insulin injections for glycemia regulation using standard clinical insulin treatment. The blood glucose records obtained by CGM indicate that trends in both methods correspond, with a glycemia median absolute relative difference of 6.1748 mg/dL and an interquartile range of 14.57 mg/dL. The response time to reach glucose levels between 70 and 180 mg/dL was around 55 min, testing different amounts of insulin units ranging from 0.09 to 2.06 U. Also, four obstruction cases were detected by the system in an average time of 3 s, showing compliance with the EN60601-2-24 standard.

Conclusions

The in vivo experiments with diabetic rats and ultra-low-cost insulin pumps demonstrate that these prototypes can be used for glucose regulation in clinical trials while complying with the conditions of the EN60601-2-24 standard. Future work should focus on conducting insulin pump tests in a closed loop and a cybersecurity study to prevent any possible external attack.