Chinese Endocrinologists Health Education Study (CREATION)

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Type 2 Diabetes
• Intervention / Treatment: Other: Intensive training for endocrinologists in T2DM management; Other: Regular training for endocrinologists in T2DM management

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 2017
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Shanghai
    • Shanghai, Shanghai, China, 200025
      • Ruijin Hospital, Shanghai Jiao Tong University School of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intensive training group; 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.	Other: Intensive training for endocrinologists in T2DM management; 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.
Active Comparator: Control group; Endocrinologists will receive regular training from MMC under the guidance of T2DM management.	Other: Regular training for endocrinologists in T2DM management; 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.

What is the study measuring?

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
Waist circumference		6 and 12 months
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
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

Collaborators and Investigators

• Sponsor: Shanghai Jiao Tong University School of Medicine

Study record dates

Study Major Dates

• Study Start (Actual): February 9, 2023
• Primary Completion (Actual): October 25, 2024
• Study Completion (Estimated): October 31, 2025

Study Registration Dates

• First Submitted: January 5, 2023
• First Submitted That Met QC Criteria: February 6, 2023
• First Posted (Actual): February 8, 2023

Study Record Updates

• Last Update Posted (Actual): May 16, 2025
• Last Update Submitted That Met QC Criteria: May 13, 2025
• Last Verified: May 1, 2025

More Information

Terms related to this study

• Other Study ID Numbers: CCEMD2022001

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No