Screening and Molecular Diagnosis-based Individualized Precision Management of Monogenic Diabetes

Not Applicable

Recruiting

• Conditions: Monogenic Diabetes

• Registration Number: NCT06746610
• Lead Sponsor: Tianjin Medical University General Hospital

Brief Summary

The goal of this observational study is to establish a registry, screening, and individualized management platform for patients with monogenic diabetes mellitus(MDM) using internet-based and mobile application software. The main questions it aims to answer are:

* What are the genetic mutations causing MDM in China (genetic landscape)?

* How effective and safe is the individualized, molecular-diagnosis-based management platform for MDM in improving patient outcomes?

Participants will:

* Register in the MDM platform via mobile app or internet-based software

* Undergo genetic screening for MDM diagnosis

* Participate in follow-up visits for individualized management and monitoring of blood glucose control and outcomes

Detailed Description

Not available

Study Timeline

• Study Start: 2022-08-01
• Status Verified: 2024-10
• Study First Submitted: 2024-12-18
• Study First Submitted QC: 2024-12-18
• Last Update Submitted: 2024-12-18
• Study First Posted: 2024-12-24
• Last Update Posted: 2024-12-24
• Primary Completion: 2027-07-31
• Study Completion: 2027-07-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 2000

Inclusion Criteria

1. Diabetes patients who developed before 25 years old; Or they were diagnosed with diabetes before the age of 35, and two or more immediate relatives were diagnosed with diabetes before the age of 45;
2. Body mass index (BMI) at diagnosis < 28 kg/m2;
3. Anti glutamic acid decarboxylase antibody (GAD Ab), anti islet cell antibody (ICA Ab), and anti insulin autoantibody (IAA Ab) were all negative;

Exclusion Criteria

1. Secondary diabetes patients with other endocrine diseases, such as hyperthyroidism or hypothyroidism, hyperparathyroidism or hypothyroidism, acromegaly, Cushing's syndrome, autoimmune multiple endocrine diseases, etc.;
2. Systemic use of corticosteroids, immunosuppressants, and other drugs within the past 6 months;
3. Patients with malignant tumors.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Genetic landscape of monogenic diabetes mellitus in China	24 months

Trial Locations

Locations (1)

Tianjin Medical University General Hospital; 🇨🇳 Tianjin, China