China Diabetes Type 1 Study (CD1S) by China Alliance for Type 1 Diabetes
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
AgeNot listed
SponsorSecond Xiangya Hospital of Central South University
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial population
Patients with type 1 diabetes or children and adolescents with diabetes mellitus at age of onset \<= 20 years
Trial design
Design model
Other
Time perspective
Other
Treatments tested in this trial
Standard type 1 diabetes management model constructed by China Alliance for Type 1 Diabetes in each center
Other interventionStandard type 1 diabetes management model constructed by China Alliance for Type 1 Diabetes in each center
Treatment groups
20,000 Participants
are divided into 2 treatment groupsGroup A: Individuals diagnosed with type 1 diabetes1 intervention
Group B: Individuals with diabetes who had an age of onset <= 20 years.1 intervention
Trial outcomes
Primary outcomes
1
Change in serum hemoglobin A1c level
A1c reflects the average blood glucose level
Time frame
Every year for up to 10 years2
Albumin-to-creatinine ratio in urine sample
Albumin-to-creatinine ratio in urine sample
Time frame
up to 10 years3
Arteriosclerotic cardiovascular diseases
Incident cases of cardiovascular diseases
Time frame
up to 10 years4
Electromyography
value of nerve conduction velocity, F wave index, H-reflex
Time frame
up to 10 yearsSecondary outcomes
1
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
Time frame
Every year for up to 10 years2
Change in titer of autoantibodies
Glutamic acid decarboxylase antibody using radioligand binding assay method
Time frame
Every year for up to 10 years3
Fasting blood glucose
the blood sugar level after fasting for eight hours
Time frame
Every year for up to 10 years4
Systolic blood pressure
Systolic blood pressure
Time frame
Every year for up to 10 yearsSponsors and contacts
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Source ClinicalTrials.gov