Cohort Study of Patients With Type 1 Diabetes

Study Overview
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Brief Summary
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This study aims to clarify the underlying hereditary and autoimmune factors that contribute to clinical type 1 diabetes and gain a better understanding of the natural history of the disease.

Official Title
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Cohort Study of Patients With Type 1 Diabetes：Clarifing the Underlying Hereditary and Autoimmune Pathogenic Factors

Conditions
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Type 1 Diabetes Mellitus, Structured Education

Intervention / Treatment
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* Other: type 1 diabetes structured education


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: diabetes diagnosed according to the report of WHO (World Health Organization) in 1999; insulin dependence from disease onset,thus diagnosed with type 1 diabetes; all patients gave informed consent to participate in the study and the protocol was approved by the Research Ethics Committee in second Xiangya hospital, Central South University. Exclusion Criteria: secondary diabetes mellitus; pregnant women; malignant disease.
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 |
| --- | --- |
| Intensive structured education group<br>Regular outpatient visit in every 3 months to these patients. The glucose control and diabetes complication screening will be evaluated in visit. Patients will also be evaluated by specialized psychologists, dietitians and therapists. Diabetes self-management education will be regularly exposed to patients | Other: type 1 diabetes structured education<br>* The structured education is based on a regular outpatients visit.It is an education that integrated several diabetes related subjects,which mainly aimed at T1D self-management.<br>|
| Conventional education group<br>Outpatients visit to endocrinologists when necessary in a conventional way. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Effects of structured education on β-cell endocrine function progression of T1D patients. | The natural progression of patients' β-cell endocrine functions was assessed by fasting C-peptide (FCP) and postprandial C-peptide (PCP) at each visit. FCP and PCP levels were measured at initial recruitment and every three months after that. The decay rate of β-cell endocrine function of patients in the two groups were compared. Serum C-peptide levels were measured by a chemiluminescence method using a commercial available kit (Adiva Centaur System, Siemens, Germany). | Baseline and every three months afterwards. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Effects of structured education on blood sugar control. | Patients' daily insulin dosage (U/Day) were collected at initial recruitment and each visit afterwards. And the above mentioned parameters in group 1(patients with structured education) and group2(patients without structured education) were compared. | Baseline and every three months afterwards. | 
| Effects of structured education on blood sugar control. | Patients' blood sugar levels were collected at initial recruitment and each visit afterwards. And the above mentioned parameters in group 1(patients with structured education) and group2(patients without structured education) were compared. | Baseline and every three months afterwards. | 
| Effects of structured education on blood sugar control. | Patients' HbA1c levels were collected at initial recruitment and each visit afterwards. And the above mentioned parameters in group 1(patients with structured education) and group2(patients without structured education) were compared.HbA1c concentration was tested by the Bio-Red Variant automatic measurement system. | Baseline and every three months afterwards. | 
| Effects of structured education on metabolic control. | Patients' body mass index (BMI) levels were collected at initial recruitment and each visit afterwards. And the above mentioned parameters in group 1(patients with structured education) and group2(patients without structured education) were compared. | Baseline and every three months afterwards. | 
| Effects of structured education on metabolic control. | Patients' systolic blood pressure (SBP) and diastolic blood pressure (DBP) levels were collected at initial recruitment and each visit afterwards. And the above mentioned parameters in group 1(patients with structured education) and group2(patients without structured education) were compared. | Baseline and every three months afterwards. | 
| Effects of structured education on metabolic control. | Patients' triglyceride (TG) and total cholesterol (TC) levels were collected at initial recruitment and each visit afterwards. And the above mentioned parameters in group 1(patients with structured education) and group2(patients without structured education) were compared. | Baseline and every three months afterwards. |