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RecruitingNCT07492004CMDRUpdated Mar 25, 2026

China Monogenic Diabetes Registry

An observational study in Neonatal Diabetes, Monogenic Diabetes and Maturity Onset Diabetes of the Young, sponsored by Tianjin Medical University General Hospital. Recruiting at 1 site in China. Per ClinicalTrials.gov, last updated 2026-03-25.

Sponsored by Tianjin Medical University General Hospital · Observational

From the registry’s dates

  • Started Feb 2021; still recruiting 5 years 7 months later.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
5,000
Sex
All
01

Study 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 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.

02

Conditions studied

  • Neonatal Diabetes
  • Monogenic Diabetes
  • Maturity Onset Diabetes of the Young

Keywords

  • Monogenic Diabetes
  • Neonatal Diabetes
  • Maturity Onset Diabetes of the Young
03

In context

Diabetes Mellitus, Type 2

9,359 studies on the registry are indexed under Diabetes Mellitus, Type 2; 1,318 are open to participants now.

This study's planned enrollment of 5,000 is above the median of 300 across 1,588 observational studies indexed under Diabetes Mellitus, Type 2.

Browse Diabetes Mellitus, Type 2 studies →

Lead sponsor

Tianjin Medical University General Hospital is the lead sponsor of 71 studies on the registry; 30 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Diabetes patients who completed gene test and necessary further tests and voluntary to be followed up will be included.

Inclusion criteria

  1. 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
  2. Body mass index (BMI) at diagnosis 28 kg/m²
  3. Negative glutamic acid decarboxylase antibody (GAD-Ab)

Exclusion criteria

Exclusion Criteria:

  1. Secondary diabetes
  2. Active malignancy or history of malignant tumor within the past 5 years
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
5,000 participants (estimated)
Target follow-up
5 Years
Patient registry
Yes
Biospecimen retention
Samples with dna

Groups and cohorts

  • Monogenic Diabetes

    Other: No Interventions

Interventions

  • OtherNo Interventions

    No Interventions

06

What researchers measure

Primary outcomes

  1. 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)

    Time frame: 6 months

07

Study locations

1 of 1 sites recruiting
  • Tianjin medical university general hospital
    Tianjin, 300052, China
    Recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 25, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07492004
Lead sponsor
Tianjin Medical University General Hospital
Responsible party
Hua Shu (Doctor, Tianjin Medical University General Hospital) — Principal investigator
First posted
Mar 25, 2026
Start date
Feb 28, 2021
Primary completion
Jul 31, 2030 (estimated)
Completion
Jul 31, 2030 (estimated)
Last update
Mar 25, 2026

Study contacts

Ming Liu
Contact
mingliu@tmu.edu.cn
+86 022-27813550
Hua Shu
Contact
shuhuawelcome@163.com
+86 15010106182

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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