China Diabetes Type 1 Study (CD1S) by China Alliance for Type 1 Diabetes

Study Overview
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Brief Summary
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The aim of the China Diabetes Type 1 Study (CD1S) is to conduct a nationwide type 1 diabetes (T1D) registry study in patients with T1D and in pediatric adolescent patients with diabetes who had an age of onset <= 20 years. CD1S compromises a retrospective study enrolling inpatients hospitalized from Jan 1st, 2016 to Dec 31, 2021, and a prospective study beginning from the year 2022.

Detailed Description
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The aim of the China Diabetes Type 1 Study (CD1S) is to conduct a nationwide type 1 diabetes (T1D) registry study to investigate the demographic characteristics, metabolic control, complications occurrence as well as risk factors of patients with T1D, and to investigate the clinical features, complications' burdens and risk factors in pediatric adolescent patients with diabetes who had an age of onset <= 20 years.

Official Title
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China Diabetes Type 1 Study (CD1S) by China Alliance for Type 1 Diabetes

Conditions
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Type1diabetes, Diabetes

Intervention / Treatment
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* Other: Standard type 1 diabetes management model constructed by China Alliance for Type 1 Diabetes in each center


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 1. Patients with type 1 diabetes mellitus of any duration; meeting criteria (1) or any of (2) or any of (3) Clinical diagnosis of type 1 diabetes by a specialist Age at onset < 15 years; no overweight or obesity at onset; previous diabetic ketoacidosis; highest random C-peptide < 200 pmol/L Initiation and continuation of insulin therapy (except pancreatic or islet transplantation) after diagnosis; positive islet autoantibodies Or 2. Children and adolescents with diabetes mellitus at age of onset <= 20 years, regardless of type and duration of disease. Exclusion Criteria: For enrolment of patients with T1D, exclusion was made if any of the following criteria were met (not applicable to those with onset under 20 years of age) No insulin dependence for at least 6 months after diagnosis of diabetes mellitus. No DKA for 1 month off insulin for those with a history of diabetes > 1 year. ③ C-peptide > 800 pmol/L at any time point.
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Individuals diagnosed with type 1 diabetes<br>All patients diagnosed with type 1 diabetes of all ages. | Other: Standard type 1 diabetes management model constructed by China Alliance for Type 1 Diabetes in each center<br>* Standard type 1 diabetes management model constructed by China Alliance for Type 1 Diabetes in each center<br>|
| Individuals with diabetes who had an age of onset <= 20 years.<br>All patients with diabetes who had an age of onset <= 20 years. | Other: Standard type 1 diabetes management model constructed by China Alliance for Type 1 Diabetes in each center<br>* Standard type 1 diabetes management model constructed by China Alliance for Type 1 Diabetes in each center<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in serum hemoglobin A1c level | A1c reflects the average blood glucose level | Every year for up to 10 years | 
| Albumin-to-creatinine ratio in urine sample | Albumin-to-creatinine ratio in urine sample | up to 10 years | 
| Arteriosclerotic cardiovascular diseases | Incident cases of cardiovascular diseases | up to 10 years | 
| Electromyography | value of nerve conduction velocity, F wave index, H-reflex | up to 10 years | 
| PHQ-9 | PHQ-9（a score between 0-27, ≥10 may indicate depression) | up to 10 years | 
| GAD-7 | GAD-7(a score between 0-21, ≥5 may indicate general anxiety) | up to 10 years | 
| WHO-5 | WHO-5 (a score between 0-100, higher score means better outcome) | up to 10 years | 
| PAID | PAID (a score between 0-100, ≥40 warrants special attention). | up to 10 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in C-peptide | C-peptide are measured before and 2-hour after a mixed meal tolerance test at each follow-up of this study | Every year for up to 10 years | 
| Change in titer of autoantibodies | Glutamic acid decarboxylase antibody | Every year for up to 10 years | 
| Fasting blood glucose | the blood sugar level after fasting for eight hours | Every year for up to 10 years | 
| Systolic blood pressure | Systolic blood pressure | Every year for up to 10 years | 
| Diastolic blood pressure | Diastolic blood pressure | Every year for up to 10 years | 
| Change in lipid profiles | Including triglyceride, total cholesterol, HDL-cholesterol and LDL-cholesterol | Every year for up to 10 years | 
| Metabolomics | un-targeted metabolomics | Every year for up to 10 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Type 1 diabetes; Diabetes in Young