Chinese Endocrinologists Health Education Study

Study Overview
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Brief Summary
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The purpose of this study is to conduct a prospective, multicenter, cluster randomized control study, evaluating the improvement for T2DM diagnosis and treatment ability in Chinese endocrinologists after 1-week intensive experiential diabetes management training in the leading center.

Detailed Description
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In the first phase (Phase I), about 200 eligible endocrinologists from National Metabolic Management Centers (MMC) (one endocrinologist in each center) will be randomized (1:1) into two groups after screening. Two groups will receive 1-week intensive experiential training in the MMC leading center (Ruijin Hospital) for T2DM management or regular MMC working training, respectively. In the second phase (Phase II) , each endocrinologist is required to manage a certain number of T2DM patients (n≈10). The total number of patients in the intensive training group and the regular training group is approximately 1000:1000. Metabolic parameters including weight, glycosylated hemoglobin (HbA1c), fasting plasma glucose (FPG), postprandial plasma glucose (PPG), fasting and postprandial insulin, blood pressure and lipid levels will be measured. Furthermore, the change of patients' quality of life and endocrinologists' prescribing habits will be evaluated. The primary objective is to determine whether an 1-week intensive experiential training in T2DM management for MMC endocrinologists has a positive effect in patients' HbA1c control rate (percentage of patients achieving HbA1c <7.0%) after 6-month management. The secondary objective is to explore the effect of intensive training on other metabolic parameters, patients' quality of life and endocrinologists' prescribing habits after 6-month and 12-month management.

Official Title
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Chinese Endocrinologists Health Education Study

Conditions
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Type 2 Diabetes

Intervention / Treatment
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* Other: Intensive experiential training in T2DM management
* Other: Regular training in T2DM management


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 1. Subjects with type 2 diabetes mellitus; 2. First visit to MMC; 3. Age 40-65 years; 4. 24.0 < BMI ≤ 35.0 kg/m2; 5. Subjects with screening HbA1c ≥ 7.5% and ≤ 10.0%, and the fasting blood glucose ≥ 8.0 mmol/l and ≤ 13.3 mmol/l; 6. Duration of diabetes less than 10 years; 7. Subjects with poorly controlled blood glucose only by 1-2 kinds of non-insulin hypoglycemic drugs for at least 2 months; 8. Subjects understand the nature, significance, potential benefits, inconvenience, and risks of the study before it starts, and fully understand the study procedures and voluntarily sign the informed consent form. Exclusion Criteria: 1. Subjects with type 1 diabetes, single gene mutation diabetes, diabetes due to pancreatic injury or other secondary diabetes (such as Cushing's syndrome, thyroid dysfunction or acromegaly, etc.); 2. Subjects with serious cardiovascular diseases, such as congenital heart disease, rheumatic heart disease, hypertrophic or dilated cardiomyopathy and chronic congestive heart failure (NYHA III-IV); acute myocarditis within 12 months; severe liver and kidney dysfunction (eGFR<60mL/min/1.73m2); mental disorder, etc. 3. Subjects with acute diabetic complications in the past 3 months; 4. Subjects who were or are using insulin to control diabetes in the past 3 months; 5. History of drug abuse; 6. History of sexually transmitted disease (such as syphilis, and HIV infection [AIDS], etc.) or in the active phase of infectious disease (such as viral hepatitis, and tuberculosis, etc.); 7. Subjects who are pregnant or in lactation; 8. Participation in other clinical trials; 9. Any condition that in the judgement of the investigator precludes participation. Details please see the study protocol.

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 65 Years

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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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intensive experiential training group<br>Endocrinologists will receive 1-week intensive training in T2DM health care, including 1-week hospitalization experience in leading center (Ruijin Hospital), health examination and results interpretation, and integrated training courses for T2DM diagnosis and treatment management. | Other: Intensive experiential training in T2DM management<br>* One-week intensive experiential training for endocrinologists, means 1-week hospitalization experience in leading center (Ruijin Hospital) including health examination and results interpretation, and attending integrated training courses for T2DM management. During patient intervention period, endocrinologists will attend the follow-up and experience sharing meeting regularly.<br>|
| Active Comparator: Regular training group<br>Endocrinologists will receive regular training from MMC under the guidance of T2DM diagnosis and treatment as a control group. | Other: Regular training in T2DM management<br>* Regular training and communication implemented by MMC leading center (Ruijin Hospital) under the guidance of T2DM diagnosis and treatment.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Glycated haemoglobin (HbA1c) control rate | percentage of patients achieving HbA1c <7.0% | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Glycated haemoglobin (HbA1c) |  | 6 and 12 months | 
| Systolic and diastolic blood pressure |  | 6 and 12 months | 
| Body weight | Body weight (Kg) or Body Mass Index (Kg/m2) | 6 and 12 months | 
| Waist circumference |  | 6 and 12 months | 
| Hip circumference |  | 6 and 12 months | 
| Fasting blood glucose levels |  | 6 and 12 months | 
| 2-hour post-prandial blood glucose levels |  | 6 and 12 months | 
| Fasting serum insulin levels |  | 6 and 12 months | 
| 2-hour post-prandial serum insulin levels |  | 6 and 12 months | 
| Serum triglycerides |  | 6 and 12 months | 
| Serum total cholesterol |  | 6 and 12 months | 
| Serum low density lipoprotein cholesterol (LDL-c) |  | 6 and 12 months | 
| Quality of life (QoL) | Quality of life will be assessed by self-reported questionnaire. | 6 and 12 months | 
| Glycated haemoglobin (HbA1c) control rate | percentage of patients achieving HbA1c <7.0% | 12 months | 
| Prescribing habits of doctors | Prescribing habits including use of hypoglycemic, lipid-lowering and antihypertensive drugs measured will be assessed through standardized questionnaire. | 12 months | 
| Diabetes knowledge of doctors | Diabetes knowledge of doctors will be assessed through self-reported questionnaire. | 12 months | 
| Adverse events | Safety outcomes | 1, 3, 6, 9, 12 months | 
| Pulse rate | Safety outcomes. | 1, 3, 6, 9, 12 months | 
| White blood cell count | Safety outcomes. | 12 months | 
| Red blood cell count | Safety outcomes. | 12 months | 
| Hemoglobin levels | Safety outcomes. | 12 months | 
| Platelet count | Safety outcomes. | 12 months | 
| Number of participants with abnormal Urine routine | Safety outcomes. Including urine protein, urine glucose, urine leukocytes, urinary ketone bodies and urine erythrocytes. | 12 months | 
| Number of participants with abnormal Hepatic function | Safety outcomes. Including aspartate aminotransferase, alanine aminotransferase, direct bilirubin, total bilirubin, albumin, total protein, alkaline phosphatase and ɣ-glutamyltransferase. | 3, 6, 9, 12 months | 
| Number of participants with abnormal Renal function | Safety outcomes. Including serum urea nitrogen, serum creatinine, and serum urinary acid. | 3, 6, 9, 12 months |