Ruijin Hospital, Shanghai Jiao Tong University School of Medicine
Shanghai, Shanghai Municipality, 200025, China
NCT Number: NCT05715307
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.
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Notify Me40 year–65 year
All sexes
Interventional
Not applicable
Shanghai, Shanghai Municipality, 200025, China
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Details please see the study protocol.
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.
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.
Time frame: 6 months
percentage of patients achieving HbA1c <7.0%
Time frame: 6 and 12 months
Time frame: 6 and 12 months
Time frame: 6 and 12 months
Body weight (Kg) or Body Mass Index (Kg/m2)
Time frame: 6 and 12 months
Time frame: 6 and 12 months
Time frame: 6 and 12 months
Time frame: 6 and 12 months
Time frame: 6 and 12 months
Time frame: 6 and 12 months
Time frame: 6 and 12 months
Time frame: 6 and 12 months
Time frame: 6 and 12 months
Time frame: 6 and 12 months
Quality of life will be assessed by self-reported questionnaire.
Time frame: 12 months
percentage of patients achieving HbA1c <7.0%
Time frame: 12 months
Prescribing habits including use of hypoglycemic, lipid-lowering and antihypertensive drugs measured will be assessed through standardized questionnaire.
Time frame: 12 months
Diabetes knowledge of doctors will be assessed through self-reported questionnaire.
Time frame: 1, 3, 6, 9, 12 months
Safety outcomes
Time frame: 1, 3, 6, 9, 12 months
Safety outcomes.
Time frame: 12 months
Safety outcomes.
Time frame: 12 months
Safety outcomes.
Time frame: 12 months
Safety outcomes.
Time frame: 12 months
Safety outcomes.
Time frame: 12 months
Safety outcomes. Including urine protein, urine glucose, urine leukocytes, urinary ketone bodies and urine erythrocytes.
Time frame: 3, 6, 9, 12 months
Safety outcomes. Including aspartate aminotransferase, alanine aminotransferase, direct bilirubin, total bilirubin, albumin, total protein, alkaline phosphatase and ɣ-glutamyltransferase.
Time frame: 3, 6, 9, 12 months
Safety outcomes. Including serum urea nitrogen, serum creatinine, and serum urinary acid.
Shanghai Jiao Tong University School of Medicine
Other
Acronym: CREATION
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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