Use of open-source artificial pancreas systems in people with Type 1 Diabetes in China
The Safety and Efficacy of Open-Source Artificial Pancreas System Among People With Type 1 Diabetes Mellitus in China
Third Affiliated Hospital, Sun Yat-Sen University · NCT06081231
This study looks at how well open-source artificial pancreas systems work for people with Type 1 Diabetes in China by checking their blood sugar control and how they feel after using the system for a few months.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 500 (estimated) |
| Ages | 3 Years to 75 Years |
| Sex | All |
| Sponsor | Third Affiliated Hospital, Sun Yat-Sen University (other) |
| Locations | 1 site (Guangzhou, Guangdong) |
| Trial ID | NCT06081231 on ClinicalTrials.gov |
What this trial studies
This observational study analyzes the use of open-source artificial pancreas systems (APS) among individuals with Type 1 Diabetes Mellitus (T1DM) in China. It collects data through clinical routines, questionnaires, and continuous glucose monitoring (CGM) from participants who have been using the APS for at least three months. The study aims to evaluate glycemic control and patient-reported outcomes by comparing baseline data with follow-up data collected at various intervals. No additional medical interventions or tests are required beyond standard clinical care.
Who should consider this trial
Good fit: Ideal candidates for this study are individuals diagnosed with Type 1 Diabetes who have been using an open-source APS for at least three months and reside in China.
Not a fit: Patients who do not use an open-source APS or have not been diagnosed with Type 1 Diabetes will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide insights into the effectiveness of open-source APS in improving glycemic control for patients with Type 1 Diabetes.
How similar studies have performed: Other studies have shown promising results with similar approaches to automated insulin delivery systems, indicating potential for success in this observational study.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Guangzhou, Guangdong
- Jinhua Yan — Guangzhou, Guangdong, China (RECRUITING)
Study contacts
- Principal investigator: Jinhua Yan, PHD,MD — Third Affiliated Hospital, Sun Yat-Sen University
- Study coordinator: Jinhua Yan, PHD,MD
- Email: yanjh79@163.com
- Phone: +8613929589959
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Type 1 Diabetes Mellitus, artificial pancreas system, automated insulin delivery, do-it-yourself, closed loop, open source