Goez-Mora Jhon E, Arbelaez-Córdoba Natalia, Balcazar-Morales Norman, Rivadeneira Pablo S
Grupo GITA, Facultad de Minas, Universidad Nacional de Colombia, Medellín, Colombia.
Grupo GENMOL, Departamento de Fisiología y Bioquímica, Facultad de Medicina, Universidad de Antioquia, Medellín, Colombia.
J Diabetes Investig. 2025 Jul 23. doi: 10.1111/jdi.70072.
This study assesses the accuracy of an ultra-low-cost insulin pump for regulating blood glucose, an essential component of the artificial pancreas.
The primary objective is to assess the accuracy of blood glucose regulation using an ultra-low-cost insulin pump compared with insulin injections.
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.
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.
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.
本研究评估一种超低成本胰岛素泵调节血糖的准确性，胰岛素泵是人工胰腺的重要组成部分。
主要目的是评估使用超低成本胰岛素泵与胰岛素注射相比调节血糖的准确性。
该研究使用了14只14周龄的雄性Wistar大鼠，通过链脲佐菌素程序诱导其患糖尿病。对照组（7只大鼠）接受皮下胰岛素注射治疗，研究组（7只大鼠）接受实验性胰岛素泵治疗。
我们的研究结果表明，在使用标准临床胰岛素治疗调节血糖方面，超低成本胰岛素泵的表现与胰岛素注射相当。连续血糖监测（CGM）获得的血糖记录表明，两种方法的趋势一致，血糖中位数绝对相对差异为6.1748mg/dL，四分位间距为14.57mg/dL。在测试0.09至2.06U不同胰岛素剂量时，达到70至180mg/dL血糖水平的响应时间约为55分钟。此外，系统平均在3秒内检测到4例阻塞情况，符合EN60601-2-24标准。
对糖尿病大鼠和超低成本胰岛素泵进行的体内实验表明，这些原型可用于临床试验中的血糖调节，同时符合EN60601-2-24标准的条件。未来的工作应集中在闭环状态下进行胰岛素泵测试以及开展网络安全研究，以防止任何可能的外部攻击。
