The Effect of Share Care Model in the Improvement of Diab... | NCT03707379

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

NCT03707379

Sponsor

Beijing Tsinghua Chang Gung Hospital

Status

Unknown status

Last Update Posted

Feb 11, 2025Actual

Enrollment

3,500Estimated

Phase

Not provided

Conditions

Diabetes Mellitus, Type 2

Interventions

Not provided

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2024

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 1, 2016Actual

Primary Completion Date

Mar 31, 2026Estimated

Completion Date

Mar 31, 2026Estimated

First Submitted Date

Jul 23, 2018

First Submission Date that Met QC Criteria

Oct 14, 2018

First Posted Date

Oct 16, 2018Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 9, 2025

Last Update Posted Date

Feb 11, 2025Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Yes

Target Follow-Up Duration

2 Years

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

3,500Estimated

Label	Type	Description	Intervention Names
common care group		diabetic patients under common care group

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Type 2 diabetic patients

Exclusion Criteria:

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Diabetic patients in Ruijing Diabetes Hospital

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Jianzhong Xiao, PHD	Contact	86-13683685711		Xiaojzh858@sina.com

Overall Officials

Name	Affiliation	Role
Jianzhong Xiao	Beijing Tsinghua Changgeng Hospital	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Beijing Ruijing Diabetes Hospital	Recruiting	Beijing	Beijing Municipality		China

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
34397707	Derived	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.

ID	Term
D044882	Glucose Metabolism Disorders
D008659	Metabolic Diseases
D009750	Nutritional and Metabolic Diseases
D004700	Endocrine System Diseases

ID	Term
D003924	Diabetes Mellitus, Type 2
D003920	Diabetes Mellitus