Single-arm, first-in-human feasibility study results for an ultra-low-cost insulin pump.

BACKGROUND: Use of Continuous Subcutaneous Insulin Infusion (CSII) has been shown to improve glycemic outcomes in Type 1 Diabetes (T1D), but high costs limit accessibility. To address this issue, an inter-operable, open-source Ultra-Low-Cost Insulin Pump (ULCIP) was developed and previously shown to demonstrate comparable delivery accuracy to commercial models in standardised laboratory tests. This study aims to evaluate the updated ULCIP in-vivo, assessing its viability as an affordable alternative for those who cannot afford commercially available devices. METHODS: This first-in-human feasibility study recruited six participants with T1D. During a nine-hour inpatient stay, participants used the ULCIP under clinical supervision. Venous glucose, insulin, and ß-Hydroxybutyrate were monitored to assess device performance. RESULTS: Participants displayed expected blood glucose and blood insulin levels in response to programmed basal and bolus insulin dosing. One participant developed mild ketosis, which was treated and did not recur when a new pump reservoir was placed. All other participants maintained ß-Hydroxybutyrate < 0.6 mmol/L throughout. CONCLUSION: The ULCIP safely delivered insulin therapy to users in a supervised inpatient environment. Future work should focus on correcting a pump hardware issue identified in this trial and extending device capabilities for use in closed loop control. Longer-term outpatient studies are warranted. TRIAL REGISTRATION: The trial was prospectively registered with the Australian New Zealand Clinical Trials Registry (ACTRN12623001288617) on the 11 December 2023.

Low-cost, low-power, clockwork syringe pump.

A low-cost ($120 NZD, $75 USD), low-power (1-year battery life), portable, and programmable syringe pump design is presented, which offers an alternative to high-cost commercial devices with limited battery life. Contrary to typical motor-driven syringe pumps, the design utilizes a compression spring coupled with a clockwork escapement mechanism to advance the syringe plunger. Full control over flow-rate and discrete (bolus) deliveries is achieved through actuation of a clockwork escapement using programmable, low-power electronics. The escapement mechanism allows the syringe plunger to advance a fixed linear distance, delivering a dose size of 0.001 ml in the configuration presented. The modular pump assembly is easily reconfigured for different applications by interchanging components to alter the minimum dose size. Testing to IEC 60601-2-24(2012), the average error of the clockwork syringe pump was 8.0%, 4.0%, and 1.9% for 0.001 ml, 0.002 ml, and 0.01 ml volumes, respectively. An overall mean error of 1.0% was recorded for a flow-rate of 0.01 ml h-1. Compared to a commercial insulin pump, the clockwork pump demonstrated reduced variability but greater average error due to consistent over-delivery. Further development of the design and/or manufacture should yield a device with similar performance to a commercial pump.

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

With the prevalence of diabetes higher than ever, governments and people with diabetes are facing significant treatment and indirect costs associated with managing their condition. An ultra-low-cost insulin pump is a possible solution to improving health disparities. This article presents test results for an insulin-pump built from low-cost components (bill of materials < $US100). All testing was completed in accordance with IEC60601-2-24, and results were benchmarked against a commercial pump. Results showed the ultra-low-cost pump has comparable accuracy to the commercially available insulin pump with testing displaying an overall accuracy of 0.089% and -0.392%, respectively. These results show that an ultra-low-cost pump can accurately deliver insulin in limited bench testing. Testing in other environments and scenarios is required to fully meet IEC60601-2-24 standards.

Design of an open source ultra low cost insulin pump.

In this report we present a design for an open source low cost insulin pump. The pump has been designed to provide an alternative to commercially available pumps costing upwards of US$6500, making them inaccessible to many. The hardware described in this article can be produced for a materials cost of US$89.85. Compared to other devices on the market, the design presented has the obvious advantage of being low cost, but is also highly customisable as it is run using open source software. The device is housed in a case of size 85 mm x 55 mm x 25 mm making it small enough to fit in a pocket, and equivalent to other devices on the market. The device is designed to work with insulin cartridges currently available on the market. Power is provided through the use of AAA batteries, and the pump is able to be recharged through a USB mini port. The accuracy of the pump has been tested and compared to data obtained from an in-warranty commercial insulin pump model using an identical testing methodology, with the ultra-low-cost pump performing similarly to the commercial model. The system can be readily extended to be controlled from external bluetooth or wired mobile devices using their built in security, offloading computation from the device and onto a phone.