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

Area of Science:

• Biomedical Engineering
• Endocrinology
• Diabetes Management

Background:

• Continuous Subcutaneous Insulin Infusion (CSII) improves glycemic control in Type 1 Diabetes (T1D).
• High costs of commercial insulin pumps limit accessibility for many patients.
• An open-source, ultra-low-cost insulin pump (ULCIP) was developed as an affordable alternative.

Purpose of the Study:

• To evaluate the in-vivo performance and safety of the updated Ultra-Low-Cost Insulin Pump (ULCIP).
• To assess the viability of the ULCIP as an accessible alternative to commercial insulin pumps for individuals with T1D.

Main Methods:

• A first-in-human feasibility study involving six participants with T1D.
• Nine-hour inpatient monitoring of ULCIP use under clinical supervision.
• Monitoring of venous glucose, insulin, and β-Hydroxybutyrate levels to assess device performance.

Main Results:

• Participants showed expected blood glucose and insulin responses to programmed insulin dosing.
• One participant experienced mild ketosis, which was resolved by replacing the pump reservoir.
• All other participants maintained β-Hydroxybutyrate levels below 0.6 mmol/L.

Conclusions:

• The ULCIP demonstrated safe insulin delivery in a supervised inpatient setting.
• Further development is needed to address a hardware issue and enhance capabilities for closed-loop control.
• Longer-term outpatient studies are recommended to further validate the ULCIP.