NCT06081231

Open-Source Artificial Pancreas System Use Among People With Type 1 Diabetes Mellitus in China

The Safety and Efficacy of Open-Source Artificial Pancreas System Among People With Type 1 Diabetes Mellitus in China

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 500 (estimated)
• Sponsor: Third Affiliated Hospital, Sun Yat-Sen University · Academic / Other
• Sex: All
• Age: 3 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This real-world observational study aims to reveal the current status of the open-source artificial pancreas system (APS) use among people with T1DM in China and assess the glycemic efficacy and potential related factors of the open-source APS.

Detailed description

This is a real-world observational study analyzing data on open-source artificial pancreas systems(APS) in people with T1DM in China. Data will collected during clinical routine, questionnaires, standard-of-care laboratory tests, and CGM data among whom are willing to share. Baseline data from before the start (up to -3 months) of the open-source APS system and follow-up data at 3, 6, 9, 12, and the following period will be analyzed when available. There are no medical interventions, extra visits, or laboratory tests planned outside the normal clinical routine. Glycemic control and patient-reported outcomes during follow-up will be compared with glycemic control and patient-reported outcome data at baseline.

Conditions

• Type 1 Diabetes Mellitus

Interventions

Type	Name	Description
DEVICE	open-source APS;	a continuous glucose monitoring system, an insulin pump, and an intelligent algorithm.

Timeline

• Start date: 2019-01-01
• Primary completion: 2026-01-01
• Completion: 2026-06-01
• First posted: 2023-10-13
• Last updated: 2024-06-24

Locations

1 site across 1 country: China