Diabetes, Type1diabetes
Conditions
Keywords
Type 1 diabetes; Diabetes in Young
Brief summary
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
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.
Interventions
OTHERStandard type 1 diabetes management model constructed by China Alliance for Type 1 Diabetes in each center
Standard type 1 diabetes management model constructed by China Alliance for Type 1 Diabetes in each center
Sponsors
Second Xiangya Hospital of Central South University
Study design
Observational model
OTHER
Time perspective
OTHER
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
* 1\. Patients with type 1 diabetes mellitus of any duration; meeting criteria (1) or any of (2) or any of (3) 1. Clinical diagnosis of type 1 diabetes by a specialist 2. Age at onset \< 15 years; no overweight or obesity at onset; previous diabetic ketoacidosis; highest random C-peptide \< 200 pmol/L 3. 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in serum hemoglobin A1c level | Every year for up to 10 years | A1c reflects the average blood glucose level |
| Albumin-to-creatinine ratio in urine sample | up to 10 years | Albumin-to-creatinine ratio in urine sample |
| Arteriosclerotic cardiovascular diseases | up to 10 years | Incident cases of cardiovascular diseases |
| Electromyography | up to 10 years | value of nerve conduction velocity, F wave index, H-reflex |
| PHQ-9 | up to 10 years | PHQ-9（a score between 0-27, ≥10 may indicate depression) |
| GAD-7 | up to 10 years | GAD-7(a score between 0-21, ≥5 may indicate general anxiety) |
| WHO-5 | up to 10 years | WHO-5 (a score between 0-100, higher score means better outcome) |
| PAID | up to 10 years | PAID (a score between 0-100, ≥40 warrants special attention). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in C-peptide | Every year for up to 10 years | C-peptide are measured before and 2-hour after a mixed meal tolerance test at each follow-up of this study |
| Change in titer of autoantibodies | Every year for up to 10 years | Glutamic acid decarboxylase antibody using radioligand binding assay method |
| Fasting blood glucose | Every year for up to 10 years | the blood sugar level after fasting for eight hours |
| Systolic blood pressure | Every year for up to 10 years | Systolic blood pressure |
| Diastolic blood pressure | Every year for up to 10 years | Diastolic blood pressure |
| Change in lipid profiles | Every year for up to 10 years | Including triglyceride, total cholesterol, HDL-cholesterol and LDL-cholesterol |
| Metabolomics | Every year for up to 10 years | un-targeted metabolomics using the LC-MS/MS system |
Countries
China
Contacts
CONTACTZhiguang Zhou, MD, PhD
CONTACTXia Li, MD, PhD
PRINCIPAL_INVESTIGATORZhiguang Zhou, MD, PhD
The Second Xiangya Hospital, Central South University
Outcome results
None listed