Neonatal DiabetesCMDRNCT07492004
China Monogenic Diabetes Registry
An observational study of Neonatal Diabetes and Monogenic Diabetes, run by Tianjin Medical University General Hospital at 1 site in China.
Trial summary
This observational study aims to establish a digital registry, screening platform for patients with monogenic diabetes using internet-based and mobile application technologies. The primary objectives are to: Characterize the genetic landscape of monogenic diabetes in the Chinese population, including pathogenic… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Neonatal Diabetes, Monogenic Diabetes, Maturity Onset Diabetes of the Young
- How many people
- 5,000 participants
- Where
- 1 siteChina
- Study dates
- 28 Feb 2021to 31 Jul 2030
- How long will I take part?
- 5 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Diabetes patients who completed gene test and necessary further tests and voluntary to be followed up will be included.
Who may be able to join
- Diabetes diagnosed before 25 years of age; OR diabetes diagnosed before 35 years of age with ≥1 first-degree relative (parent, sibling, or offspring) diagnosed with diabetes before 40 years of age
- Body mass index (BMI) at diagnosis 28 kg/m²
- Negative glutamic acid decarboxylase antibody (GAD-Ab)
Who cannot join
- Secondary diabetes
- Active malignancy or history of malignant tumor within the past 5 years
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Tianjin medical university general hospital
Tianjin, 300052
Ming Liu, +86 022-27813550, mingliu@tmu.edu.cn
Hua Shu, +86 15010106182, shuhuawelcome@163.com
About this study
This observational study aims to establish a digital registry, screening platform for patients with monogenic diabetes using internet-based and mobile application technologies. The primary objectives are to:
Characterize the genetic landscape of monogenic diabetes in the Chinese population, including pathogenic variants and their distribution
Participants will:
- Enroll in the monogenic diabetes registry via mobile application or web-based platform
- Undergo molecular genetic testing to establish a definitive diagnosis
Read the detailed description
This study will include the subjects of a series of studies on monogenic diabetes conducted by our team, including neonatal diabetes, maturity-onset diabetes of the young, maternally inherited diabetes and deafness, and other monogenic diabetes caused by different causative genes, and establish a large sample database and specimen bank through follow-up and omics analysis.
- Being tested
- No Interventions
- Keywords
- Monogenic Diabetes, Neonatal Diabetes, Maturity Onset Diabetes of the Young
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No InterventionsOther
No Interventions
| Study group | Role | What they receive |
|---|---|---|
| Monogenic Diabetes | Not described Receives: Other: No Interventions |
What is being measured
The primary outcome is the main question the study is designed to answer.
Screened and confirmed monogenic diabetes
Screened and confirmed through genetic testing according to established diagnostic criteria for monogenic forms of diabetes (including MODY, neonatal diabetes, and other monogenic subtypes)
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Mar 2026
- Study start28 Feb 2021
- Primary completion31 Jul 2030 (estimated)
- Study completion31 Jul 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neonatal DiabetesStudies 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
- Prospective
- Enrolment
- 5,000 participants (estimated)
- Target duration
- 5 Years
Sponsor and investigators
- Lead sponsor
- Tianjin Medical University General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hua Shu, Tianjin Medical University General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07492004
- Sponsor's protocol ID
- IRB2022-YX-164-02
- Acronym
- CMDR
- Status last verified
- Mar 2026
- First submitted
- 19 Mar 2026
- Last updated
- 25 Mar 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- China Monogenic Diabetes Registry
- ClinicalTrials.gov ID
- NCT07492004
- Acronym / sponsor ID
- CMDR / IRB2022-YX-164-02
- Keywords
- Monogenic Diabetes, Neonatal Diabetes, Maturity Onset Diabetes of the Young
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 5,000 participants (estimated)
- Lead sponsor
- Tianjin Medical University General HospitalUniversity, hospital or other
- Study start
- 28 Feb 2021 (actual)
- Primary completion
- 31 Jul 2030 (estimated)
- Study completion
- 31 Jul 2030 (estimated)
- First posted
- 25 Mar 2026 (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 observational study aims to establish a digital registry, screening platform for patients with monogenic diabetes using internet-based and mobile application technologies. The primary objectives are to:
Characterize the genetic landscape of monogenic diabetes in the Chinese population, including pathogenic variants and their distribution
Participants will:
- Enroll in the monogenic diabetes registry via mobile application or web-based platform
- Undergo molecular genetic testing to establish a definitive diagnosis
Detailed description
This study will include the subjects of a series of studies on monogenic diabetes conducted by our team, including neonatal diabetes, maturity-onset diabetes of the young, maternally inherited diabetes and deafness, and other monogenic diabetes caused by different causative genes, and establish a large sample database and specimen bank through follow-up and omics analysis.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 5 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Monogenic Diabetes | – | Other: No Interventions |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Diabetes patients who completed gene test and necessary further tests and voluntary to be followed up will be included.
Key inclusion criteria (3 listed)
- Diabetes diagnosed before 25 years of age; OR diabetes diagnosed before 35 years of age with ≥1 first-degree relative (parent, sibling, or offspring) diagnosed with diabetes before 40 years of age
- Body mass index (BMI) at diagnosis 28 kg/m²
- Negative glutamic acid decarboxylase antibody (GAD-Ab)
Key exclusion criteria (2 listed)
- Secondary diabetes
- Active malignancy or history of malignant tumor within the past 5 years
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 |
|---|---|---|
| No InterventionsNo Interventions | Other | Monogenic Diabetes |
Primary outcome
Screened and confirmed monogenic diabetes
Time frame: 6 months
Screened and confirmed through genetic testing according to established diagnostic criteria for monogenic forms of diabetes (including MODY, neonatal diabetes, and other monogenic subtypes)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Mar 2026.
- 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.
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 Neonatal Diabetes and Monogenic Diabetes, run by Tianjin Medical University General Hospital 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 3 inclusion and 2 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: looking for participants now, as of the sponsor's last update on 25 Mar 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ming Liu (+86 022-27813550, mingliu@tmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Screened and confirmed monogenic diabetes (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 25 Mar 2026.