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

Sun Yat-sen University

Status: Enrolling

Conditions: Type 1 Diabetes Mellitus

Treatments: Device: open-source APS;

Study type: Observational

Funder types: Other

Identifiers

NCT06081231

MLei2

Details and patient eligibility

About

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.

Full 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.

Enrollment: 500 estimated patients

Sex: All

Ages: 3 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. diagnosed T1DM.
2. Currently use open-source APS for at least 3 months.
3. Willing and able to provide informed consent (or be a parent or other legally authorized representative) and to provide the data.
4. reside in China.

Exclusion criteria

None

Trial design

500 participants in 1 patient group

open-source APS

Description:

open-source APS consisted of an insulin pump, a CGM system, and a heuristic algorithm on an Android smartphone.

Treatment:

Device: open-source APS;