Personalized management for monogenic diabetes using genetic screening
Screening and Molecular Diagnosis-based Individualized Precision Management of Monogenic Diabetes
NA · Tianjin Medical University General Hospital · NCT06746610
This study is testing a new online platform that helps people with monogenic diabetes by using genetic screening to create personalized treatment plans for better blood sugar control.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 2000 (estimated) |
| Sex | All |
| Sponsor | Tianjin Medical University General Hospital (other) |
| Locations | 1 site (Tianjin) |
| Trial ID | NCT06746610 on ClinicalTrials.gov |
What this trial studies
This observational study aims to create a registry and management platform for patients with monogenic diabetes mellitus (MDM) through internet-based and mobile application software. Participants will register on the platform, undergo genetic screening to identify mutations causing MDM, and receive individualized management and monitoring for blood glucose control. The study seeks to understand the genetic landscape of MDM in China and evaluate the effectiveness and safety of this personalized approach in improving patient outcomes.
Who should consider this trial
Good fit: Ideal candidates include diabetes patients diagnosed before age 25 or those diagnosed before age 35 with a family history of early-onset diabetes.
Not a fit: Patients with secondary diabetes due to other endocrine diseases or those who have used corticosteroids or immunosuppressants recently may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to more effective and tailored management strategies for patients with monogenic diabetes.
How similar studies have performed: Other studies have shown promise in using genetic screening for personalized diabetes management, indicating potential success for this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Tianjin
- Tianjin Medical University General Hospital — Tianjin, China (RECRUITING)
Study contacts
- Study coordinator: Ming Liu
- Email: mingliu@tmu.edu.cn
- Phone: +86 183 2201 7516
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Monogenic Diabetes