Accuracy Evaluation of a Novel Reusable Patch Pump Prototype.

Area of Science:

• Biomedical Engineering
• Medical Devices
• Diabetes Technology

Background:

• Insulin patch pumps are crucial for diabetes management, offering discreet and automated insulin delivery.
• Ensuring accurate insulin delivery and reliable safety features like occlusion detection is paramount for patient safety and glycemic control.
• Existing commercial insulin pumps vary in their performance regarding accuracy and safety mechanisms.

Purpose of the Study:

• To evaluate the accuracy of bolus and basal insulin delivery from a novel insulin patch pump prototype.
• To assess the effectiveness and speed of the prototype's occlusion detection system.
• To compare the performance of the prototype against established commercial insulin pumps.

Main Methods:

• A microgravimetric method was employed to precisely measure insulin delivery accuracy for bolus doses (0.2 U, 1.0 U) and basal rates (1.0 U/h).
• Occlusion detection time was assessed at two different basal rates (0.1 U/h and 1.0 U/h).
• Performance metrics were compared with data from commercially available insulin pumps tested using similar methodologies.

Main Results:

• The prototype exhibited high accuracy, with mean deviations below 2% for both 0.2 U and 1.0 U bolus deliveries.
• Basal rate accuracy over 72 hours showed a mean deviation of less than 1%.
• Occlusion detection was achieved in under 30 minutes at both tested basal rates.

Conclusions:

• The tested insulin patch pump prototype demonstrates excellent accuracy in insulin delivery, meeting or exceeding the performance of many commercial devices.
• The prototype's occlusion detection system is effective and operates within clinically relevant timeframes.
• These findings suggest the prototype holds significant promise as a reliable and safe alternative for insulin therapy in diabetes management.