The Effect of Share Care Model in the Improvement of Diabetes Management

The situation of diabetes management in China is serious. To set up hierarchical medical system is necessary, though there was no mature or effective diabetes management model in the mainland. To explore a new path for hierarchical medical system, we would localize the share care model of diabetes management in Taiwan. Diabetic experts, diabetic educators and community doctors would use interactive information platform and self-glucose monitor with application on mobile phone to manage diabetic patients together. The model will be applied in six diabetic centers, and patients we will be managed in the new model and followed, and at the same time patients that managed in the conventional model in the real world, the differences of proportion who achieve a composite goal will be compared yearly for 5 years.

Study Overview

• Status: Recruiting
• Conditions: Diabetes Mellitus, Type 2

• Study Type: Observational
• Enrollment (Anticipated): 3500

Contacts and Locations

• Study Contact: Name: Jianzhong Xiao, PHD; Phone Number: 86-13683685711; Email: Xiaojzh858@sina.com

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China
      • Recruiting
      • Beijing Ruijing Diabetes Hospital
      • Contact: Guojing Zhuo; Phone Number: 86-10-86393989

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Diabetic patients in Ruijing Diabetes Hospital

Description

Inclusion Criteria:

• Type 2 diabetic patients

Exclusion Criteria:

• Patients had not signed the consent form
• Patients with sever hart failure, hepatic failure, renal failure

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
common care group; diabetic patients under common care group

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
HbA1c	control rate of HbA1c<7.0%	1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
blood pressure	control rate of blood pressure<140/90 millimetres of mercury	1 year
LDL-C	control rate of LDL-C<2.6mmol/L	1 year

Collaborators and Investigators

• Sponsor: Beijing Tsinghua Chang Gung Hospital
• Investigators: Study Director: Jianzhong Xiao, Beijing Tsinghua Changgeng Hospital

Publications and helpful links

General Publications

• An L, Wang Y, Cao C, Chen T, Zhang Y, Chen L, Ren S, Tang M, Ma F, Li X, Yuan S, Zhao W, Lee Y, Xiao J. Screening cardiovascular risk factors of diabetes patients in the primary diabetes clinics. Medicine (Baltimore). 2021 Jul 30;100(30):e26722. doi: 10.1097/MD.0000000000026722.

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2016
• Primary Completion (Anticipated): March 31, 2026
• Study Completion (Anticipated): March 31, 2026

Study Registration Dates

• First Submitted: July 23, 2018
• First Submitted That Met QC Criteria: October 14, 2018
• First Posted (Actual): October 16, 2018

Study Record Updates

• Last Update Posted (Actual): August 6, 2021
• Last Update Submitted That Met QC Criteria: August 4, 2021
• Last Verified: January 1, 2021

More Information

Terms related to this study

• Keywords: Diabetes mellitus; Diabetic management; Share care
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2
• Other Study ID Numbers: 【2016】004

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No