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

NCT ID: NCT06081231

Last Updated: 2024-06-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Total Enrollment

500 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-01-01

Study Completion Date

2026-06-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

See the medical conditions and disease areas that this research is targeting or investigating.

Type 1 Diabetes Mellitus

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

OTHER

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

open-source APS

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

open-source APS;

Intervention Type DEVICE

a continuous glucose monitoring system, an insulin pump, and an intelligent algorithm.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

open-source APS;

a continuous glucose monitoring system, an insulin pump, and an intelligent algorithm.

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

3 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Third Affiliated Hospital, Sun Yat-Sen University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Jinhua Yan

Vice Professor,Principal Investigator,Department of Endocrinology and Metabolism

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Jinhua Yan, PHD,MD

Role: PRINCIPAL_INVESTIGATOR

Third Affiliated Hospital, Sun Yat-Sen University

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Jinhua Yan

Guangzhou, Guangdong, China

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

China

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Jinhua Yan, PHD,MD

Role: CONTACT

+8613929589959

Wen Xu, PHD,MD

Role: CONTACT

02085253000

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Jinhua Yan

Role: primary

+8613929589959

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

MLei2

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

The OpenAPS_ShadowMode Study
NCT03720080 TERMINATED