Cohort Study of Patients With Type 1 Diabetes

Completed

• Conditions: Structured Education; Type 1 Diabetes Mellitus
• Interventions: Other: type 1 diabetes structured education

• Registration Number: NCT03610984
• Lead Sponsor: Second Xiangya Hospital of Central South University

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-10-01
• Study First Submitted: 2018-05-11
• Study First Submitted QC: 2018-07-25
• Study First Posted: 2018-08-02
• Primary Completion: 2021-12-31
• Study Completion: 2021-12-31
• Status Verified: 2022-07
• Last Update Submitted: 2022-07-02
• Last Update Posted: 2022-07-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 2110

Inclusion Criteria

1. diabetes diagnosed according to the report of WHO (World Health Organization) in 1999;
2. insulin dependence from disease onset,thus diagnosed with type 1 diabetes;
3. 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

1. secondary diabetes mellitus;
2. pregnant women;
3. malignant disease.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Intensive structured education group	type 1 diabetes structured education	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

Primary Outcome Measures

Name	Time	Method
Effects of structured education on β-cell endocrine function progression of T1D patients.	Baseline and every three months afterwards.	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).

Secondary Outcome Measures

Name	Time	Method
Effects of structured education on blood sugar control.	Baseline and every three months afterwards.	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.
Effects of structured education on metabolic control.	Baseline and every three months afterwards.	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.

Trial Locations

Locations (1)

Institute of Metabolism and Endocrinology, Second Xiangya Hospital, Central South University; 🇨🇳 Changsha, Hunan, China