First Generation of a Modular Interoperable Closed-Loop System for Automated Insulin Delivery in Patients With Type 1...

Area of Science:

• Endocrinology
• Medical Devices
• Diabetes Technology

Background:

• Diabeloop Generation 1 (DBLG1) is a leading commercial closed-loop system for type 1 diabetes management.
• It is one of five such systems available globally as of 2023.

Purpose of the Study:

• To provide a comprehensive overview of data concerning DBLG1 system outcomes and patient populations.
• To emphasize the system's interoperability with different insulin pumps.

Main Methods:

• Analysis of data from three randomized control trials and five real-life surveys.
• Data collection spanned from March 2017 to April 2022, involving 6859 adult patients.
• Evaluation of system performance with three different insulin pump systems: Vicentra Kaleido, Sooil Dana-I, and Roche Insight.

Main Results:

• Significant improvement in Time in Range (TIR) of 70-180 mg/dL, increasing by 12.2-17.3 percentage points (from 47.4% to 56.6%).
• Average reduction in time spent in hypoglycemia by 48% (range: 26%-70%), reaching 1.3% in the largest cohort.
• A 59% reduction in Time Below Range (TBR) for patients with baseline hypoglycemia (≥5%).

Conclusions:

• The DBLG1 closed-loop system demonstrates efficiency, safety, and interoperability across various European countries and pump types.
• Consistent improvements in TIR and reductions in hypoglycemia confirm the system's effectiveness.
• The system's ability to integrate with multiple pump settings highlights its interoperability.