Chinese Endocrinologists Health Education Study

NCT05715307 | Active Not Recruiting DMC

• 1 other identifier: CCEMD2022001
• Study Type: interventional
• Target: 2,017
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Type 2 Diabetes

Outcome Measures

Primary Outcomes (1)

• Glycated haemoglobin (HbA1c) control rate

  percentage of patients achieving HbA1c \<7.0%

  6 months

Secondary Outcomes (25)

• Glycated haemoglobin (HbA1c)

  6 and 12 months

• Systolic and diastolic blood pressure

  6 and 12 months

• Body weight

  6 and 12 months

• Waist circumference

  6 and 12 months

• Hip circumference

  6 and 12 months

Study Arms (2)

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.

Other: Intensive training for endocrinologists in T2DM management

Control group

ACTIVE COMPARATOR

Endocrinologists will receive regular training from MMC under the guidance of T2DM management.

Other: Regular training for endocrinologists in T2DM management

Interventions

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.

Intensive training group

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.

Control group

Eligibility Criteria

• Age: 40 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \. Subjects with type 2 diabetes mellitus;
• \. First visit to MMC;
• \. Age 40-65 years;
• \. 24.0 \< BMI ≤ 35.0 kg/m2;
• \. Subjects with screening HbA1c ≥ 7.5% and ≤ 10.0%, and the fasting blood glucose ≥ 8.0 mmol/l and \< 13.3 mmol/l;
• \. Duration of diabetes less than 10 years;
• \. Subjects with poorly controlled blood glucose only by 1-2 kinds of non-insulin hypoglycemic drugs for at least 2 months;
• \. 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.

You may not qualify if:

• \. 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.);
• \. 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.
• \. Subjects with acute diabetic complications in the past 3 months;
• \. Subjects who were or are using insulin to control diabetes in the past 3 months;
• \. History of drug abuse;
• \. 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.);
• \. Subjects who are pregnant or in lactation;
• \. Participation in other clinical trials;
• \. Any condition that in the judgement of the investigator precludes participation.
• Details please see the study protocol.

Sponsors & Collaborators

• Shanghai Jiao Tong University School of Medicine: lead

Study Sites (1)

Ruijin Hospital, Shanghai Jiao Tong University School of Medicine

Shanghai, Shanghai Municipality, 200025, China

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

Endocrinologists

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Physicians; Health Personnel; Health Care Facilities Workforce and Services

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: January 5, 2023
• First Posted: February 8, 2023
• Study Start: February 9, 2023
• Primary Completion: October 25, 2024
• Study Completion: October 31, 2025
• Last Updated: May 16, 2025

Record last verified: 2025-05

Locations

CN (1)