China Monogenic Diabetes Registry

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
AgeNot listed
SponsorTianjin Medical University General Hospital

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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)

Disqualifiers

Secondary diabetes

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

Trial population

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

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • No Interventions

    Other intervention

    No Interventions

Treatment groups

5,000 Participants
are divided into 1 treatment group
Group A: Monogenic Diabetes1 intervention

Trial outcomes

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

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.