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The purpose of this study is to conduct a prospective, multicenter, cluster randomized control study, to evaluate the improvement for T2DM treatment ability in Chinese endocrinologists after 1-week intensive experiential diabetes management training in Ruijin Hospital.
The primary objective is to determine whether a 1-week intensive experiential training in T2DM management for MMC endocrinologists has a positive effect on 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 experiential training on other metabolic parameters, patients' quality of life and endocrinologists' prescribing habits after 6-month and 12-month management.
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. Intensive training group will receive a 1-week intensive experiential training in the MMC leading center (Ruijin Hospital) for T2DM management, and control group will receive regular MMC working training. In the second phase (Phase II) , each endocrinologist will be required to manage a certain number of T2DM patients (n≈10). The total number of patients in the intensive training group and the control group will be approximately 1000:1000. Metabolic parameters including weight, body mass index (BMI), waist circumference, hip circumference, 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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intensive training group | Experimental | Endocrinologists will receive a 1-week intensive training in T2DM health care at Ruijin Hospital. This training includes a 1-week hospitalization experience, health examinations, results interpretation, and integrated courses for T2DM management. |
|
| Control group | Active Comparator | Endocrinologists will receive regular training from MMC under the guidance of T2DM management. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Intensive training for endocrinologists in T2DM management | Other | One-week intensive experiential training for endocrinologists includes a 1-week hospitalization experience at Ruijin Hospital, involving health examinations, results interpretation, and integrated training courses for T2DM management. During the patient intervention period, endocrinologists will each manage approximately 10 T2DM patients, conduct regular follow-ups, and participate in regular training sessions, including experience-sharing meetings. |
| Measure | Description | Time Frame |
|---|---|---|
| Glycated haemoglobin (HbA1c) control rate | percentage of patients achieving HbA1c <7.0% | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Glycated haemoglobin (HbA1c) | 6 and 12 months | |
| Systolic and diastolic blood pressure | 6 and 12 months | |
| Body weight |
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Inclusion Criteria:
Exclusion Criteria:
Details please see the study protocol.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ruijin Hospital, Shanghai Jiao Tong University School of Medicine | Shanghai | Shanghai Municipality | 200025 | China |
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| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D000072097 | Endocrinologists |
| ID | Term |
|---|---|
| D010820 | Physicians |
| D006282 | Health Personnel |
| D005159 | Health Care Facilities Workforce and Services |
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| Regular training for endocrinologists in T2DM management | Other | Regular training and communication are implemented by Ruijin Hospital under the guidance of T2DM management. During the patient intervention period, endocrinologists will each manage approximately 10 T2DM patients, conduct regular follow-ups, and receive regular routine training. |
|
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 |
| D004700 | Endocrine System Diseases |