Type 1 Diabetes MellitusNCT06081231
Open-Source Artificial Pancreas System Use Among People With Type 1 Diabetes Mellitus in China
An observational study of Type 1 Diabetes Mellitus, run by Third Affiliated Hospital, Sun Yat-Sen University at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 3 to 75 years
- Conditions the study is for
- Type 1 Diabetes Mellitus
- What is being tested?
- open-source APS;
- Type of treatment
- Medical device
- How many people
- 500 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2019to 1 Jun 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 to 75 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: people with T1DM regardless of age or pregnant state.
Who may be able to join
- diagnosed T1DM.
- Currently use open-source APS for at least 3 months.
- Willing and able to provide informed consent (or be a parent or other legally authorized representative) and to provide the data.
- reside in China.
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Jinhua Yan
Guangzhou, Guangdong, 510630
Jinhua Yan, +8613929589959, yanjh79@163.com
About this study
Official title: The Safety and Efficacy of Open-Source Artificial Pancreas System Among People With Type 1 Diabetes Mellitus in China
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.
Read the 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
- Being tested
- open-source APS;
- Keywords
- artificial pancreas system, automated insulin delivery, do-it-yourself, closed loop, open source
- Medical subject headings
- Diabetes Mellitus, Type 1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
open-source APS;Device
a continuous glucose monitoring system, an insulin pump, and an intelligent algorithm.
| Study group | Role | What they receive |
|---|---|---|
| open-source APS | open-source APS consisted of an insulin pump, a CGM system, and a heuristic algorithm on an Android smartphone. Receives: Device: open-source APS; |
What is being measured
The primary outcome is the main question the study is designed to answer.
proportion of time spent in the target glucose range
time in range(TIR, 70-180mg/dL)
Measured: baseline(at least 2 weeks before the start of APS), and 3 months,6 months, 9 months, 12 months, and following period after the start of APS
Secondary outcomes (3)
proportion of time spent in the hypoglycemic range
time below range(TBR, <70mg/dL;<54mg/dL)
Measured: baseline(at least 2 weeks before the start of APS), and 3 months,6 months, 9 months, 12 months, and following period after the start of APS
proportion of time spent in the hyperglycemic range
time above range(TAR, >180mg/dL;>250mg/dL)
Measured: baseline(at least 2 weeks before the start of APS), and 3 months,6 months, 9 months, 12 months, and following period after the start of APS
concentration of HbA1c
glycated hemoglobin A1C
Measured: baseline(at least 2 weeks before the start of APS), and 3 months,6 months, 9 months, 12 months, and following period after the start of APS
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Oct 2023
- Study start1 Jan 2019
- Primary completion1 Jan 2026 (estimated)
- Study completion1 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Type 1 Diabetes MellitusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Third Affiliated Hospital, Sun Yat-Sen University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jinhua Yan, Third Affiliated Hospital, Sun Yat-Sen University
- Investigators
- Jinhua Yan, PHD,MD, Principal investigator, Third Affiliated Hospital, Sun Yat-Sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06081231
- Sponsor's protocol ID
- MLei2
- Status last verified
- Jun 2024
- First submitted
- 26 Sep 2023
- Last updated
- 24 Jun 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Zhou Y, Ni Y, Deng H, Lin Q, Lei M, Lin Z, Yang D, Cao Y, Zhao Y, Wheeler BJ, Yang X, Xu W, Yan J. Early Use of Automated Insulin Delivery With Telehealth Support in People Recently Diagnosed With Type 1 Diabetes: One-Year Outcomes From a Prospective Observational Study. Diabetes Obes Metab. 2026 Sep 17. doi: 10.1111/dom.71347. Online ahead of print.
PubMed 42755122
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Safety and Efficacy of Open-Source Artificial Pancreas System Among People With Type 1 Diabetes Mellitus in China
- ClinicalTrials.gov ID
- NCT06081231
- Acronym / sponsor ID
- MLei2
- Conditions
- Type 1 Diabetes Mellitus
- Keywords
- artificial pancreas system, automated insulin delivery, do-it-yourself, closed loop, open source
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Third Affiliated Hospital, Sun Yat-Sen UniversityUniversity, hospital or other
- Study start
- 1 Jan 2019 (actual)
- Primary completion
- 1 Jan 2026 (estimated)
- Study completion
- 1 Jun 2026 (estimated)
- First posted
- 13 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| open-source APS | – | Device: open-source APS;open-source APS consisted of an insulin pump, a CGM system, and a heuristic algorithm on an Android smartphone. |
Who may qualify
- Ages
- 3 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- people with T1DM regardless of age or pregnant state.
Key inclusion criteria (4 listed)
- diagnosed T1DM.
- Currently use open-source APS for at least 3 months.
- Willing and able to provide informed consent (or be a parent or other legally authorized representative) and to provide the data.
- reside in China.
Key exclusion criteria (1 listed)
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| open-source APS;a continuous glucose monitoring system, an insulin pump, and an intelligent algorithm. | Device | open-source APS |
Primary outcome
proportion of time spent in the target glucose range
Time frame: baseline(at least 2 weeks before the start of APS), and 3 months,6 months, 9 months, 12 months, and following period after the start of APS
time in range(TIR, 70-180mg/dL)
3 secondary outcomes
proportion of time spent in the hypoglycemic range
Time frame: baseline(at least 2 weeks before the start of APS), and 3 months,6 months, 9 months, 12 months, and following period after the start of APS
proportion of time spent in the hyperglycemic range
Time frame: baseline(at least 2 weeks before the start of APS), and 3 months,6 months, 9 months, 12 months, and following period after the start of APS
concentration of HbA1c
Time frame: baseline(at least 2 weeks before the start of APS), and 3 months,6 months, 9 months, 12 months, and following period after the start of APS
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jun 2024.
- Derived from this study: PubMed 42755122Zhou Y, Ni Y, Deng H, Lin Q, Lei M, Lin Z, Yang D, Cao Y, Zhao Y, Wheeler BJ, Yang X, Xu W, Yan J. Early Use of Automated Insulin Delivery With Telehealth Support in People Recently Diagnosed With Type 1 Diabetes: One-Year Outcomes From a Prospective Observational Study. Diabetes Obes Metab. 2026 Sep 17. doi: 10.1111/dom.71347. Online ahead of print.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jinhua Yan, PHD,MD principal investigator
Third Affiliated Hospital, Sun Yat-Sen University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Type 1 Diabetes Mellitus, run by Third Affiliated Hospital, Sun Yat-Sen University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 24 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jinhua Yan, PHD,MD (+8613929589959, yanjh79@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
proportion of time spent in the target glucose range (time frame: baseline(at least 2 weeks before the start of APS), and 3 months,6 months, 9 months, 12 months, and following period after the start of APS). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06081231, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jun 2024.