Type 1 Diabetes
Conditions
Interventions
Case series:NA
Sponsors
Beijing Hospital
Eligibility
Sex/Gender
All
Age
2 Years to 30 Years
Inclusion criteria
Inclusion criteria: 1. FDRs (such as a parent, sibling, or offspring) of T1D probands, including classical T1D and LADA. 2. Age between 2 and 30 years, inclusive (at the time of signing the informed consent). 3. Have given written informed consent to participate.
Exclusion criteria
Exclusion criteria: 1. Have been clinically diagnosed with diabetes according to the ADA diagnostic criteria, including but not limited to T1D, type 2 diabetes (T2D), monogenic diabetes, gestational diabetes (GDM), and others. 2. The affected probands has T2D, monogenic diabetes, or diabetes secondary to another medical condition. 3. Have previous or current use of medications for the control of hyperglycaemia (e.g., insulin, oral hypoglycaemic agents). 4. Currently be using systemic immunosuppressive or immunomodulatory therapies (topical and inhaled agents are acceptable). 5. Have any known severe active diseases, and/or other diseases which are likely to limit life expectancy or lead to the use of immunosuppressive or immunomodulatory therapies during the study. 6. Any medical history or clinically relevant abnormality that is deemed by the investigator to make the participant ineligible for inclusion because problems in interpreting data or safety concern. 7. Expected non-compliance with the protocol. 8. Participating in interventional or other drug research studies which could affected the primary objectives of the study. 9. Pregnant or lactating women.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The diagnosis of Stage 3 T1D per the American Diabetes Association (ADA) criteria over 5-year follow up in autoantibody positive FDRs, including the 5- year cumulative incidence and time to diagnosis of Stage 3 T1D.; | — |
Secondary
| Measure | Time frame |
|---|---|
| The proportion of participants with a single positive autoantibody and multiple positive autoantibodies.;The development of Stage 2 T1D over 5- year follow up in single autoantibody positive and Stage 1 T1D participants.;The development of multiple positive autoantibodies over 5-year follow up in single autoantibody positive participants.;Changes in HbA1c, glucose tolerance and C-peptide as assessed by oral glucose tolerance test (OGTT) over 5-year follow up in Stage 1 and Stage 2 T1D participants.;Rate of decline in beta cell function (Cpeptide levels) as assessed by mixed meal tolerance test (MMTT) over the first 12 months from diagnosis in newly diagnosed Stage 3 T1D participants in the extension follow-up period.;Changes in HbA1c, glucose levels, insulin dose, autoantibody positivity over the first 12 months from diagnosis in newly diagnosed Stage 3 T1D participants in the extension follow-up period.;Occurrence of DKA at time of Stage 3 T1D diagnosis and number of days of hospitalization in intensive care unit and total number of days at hospital.; | — |
Countries
China
Contacts
Public ContactLixin Guo
Beijing Hospital
Outcome results
None listed