Screening and Molecular Diagnosis-based Individualized Precision Management of Monogenic Diabetes (NCT06746610) | Clinical Trial Compass
RecruitingNot Applicable
Screening and Molecular Diagnosis-based Individualized Precision Management of Monogenic Diabetes
China2,000 participantsStarted 2022-08-01
Plain-language 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
Who can participate
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. 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;
. Body mass index (BMI) at diagnosis \< 28 kg/m2;
. Anti glutamic acid decarboxylase antibody (GAD Ab), anti islet cell antibody (ICA Ab), and anti insulin autoantibody (IAA Ab) were all negative;
Exclusion criteria
. Secondary diabetes patients with other endocrine diseases, such as hyperthyroidism or hypothyroidism, hyperparathyroidism or hypothyroidism, acromegaly, Cushing's syndrome, autoimmune multiple endocrine diseases, etc.;
. Systemic use of corticosteroids, immunosuppressants, and other drugs within the past 6 months;
. Patients with malignant tumors.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Genetic landscape of monogenic diabetes mellitus in China
Timeframe: 24 months
Trial details
NCT IDNCT06746610
SponsorTianjin Medical University General Hospital