China Monogenic Diabetes Registry

NCT07492004 | Recruiting

• 1 other identifier: IRB2022-YX-164-02
• Study Type: observational
• Target: 5,000
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

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

Keywords

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

Outcome Measures

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)

  6 months

Study Arms (1)

Monogenic Diabetes

Other: No Interventions

Interventions

No Interventions OTHER

No Interventions

Monogenic Diabetes

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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)

You may not qualify if:

• Secondary diabetes
• Active malignancy or history of malignant tumor within the past 5 years

Sponsors & Collaborators

• Tianjin Medical University General Hospital: lead

Study Sites (1)

Tianjin medical university general hospital

Tianjin, 300052, China

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Serum, plasma and complete blood cell

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Central Study Contacts

Ming Liu

CONTACT

+86 022-27813550; mingliu@tmu.edu.cn

Hua Shu

CONTACT

+86 15010106182; shuhuawelcome@163.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 5 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Doctor

Study Record Dates

• First Submitted: March 19, 2026
• First Posted: March 25, 2026
• Study Start: February 28, 2021
• Primary Completion (Estimated): July 31, 2030
• Study Completion (Estimated): July 31, 2030
• Last Updated: March 25, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)