China Monogenic Diabetes Registry

N/ARecruitingNCT07492004

Tianjin Medical University General Hospital5,000 enrolled

Overview

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

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 Type

OBSERVATIONAL

Enrollment

5,000

Conditions

Neonatal Diabetes Monogenic Diabetes Maturity Onset Diabetes of the Young

Interventions

Eligibility

Sex: ALL

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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