Establishment and Preliminary Evaluation of Digital Three Level Linkage Whole Process Diabetes Management System

Diabetes Mellitus Clinical Trial

Official title:

Establishment and Preliminary Evaluation of Digital Three Level Linkage Whole Process Diabetes Management System

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04999722
• Other study ID #: 2021CQSDWRMYYEC-004
• Status: Not yet recruiting
• Phase: N/A
• Start date: August 25, 2021
• Est. completion date: June 24, 2022

Study information

• Verified date: July 2021
• Source: Chongqing Renji Hospital, University of Chinese Academy of Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study used Nan'an District of Chongqing, China as a pilot project to improve the comprehensive compliance rate of diabetic patients in China, and reduce the physical and economic harm caused by complications.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 1200
• Est. completion date: June 24, 2022
• Est. primary completion date: December 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

1. Clinical diagnosis of type 2 diabetes.

2. Aged 18-70;

3. HbA1c = 8.0%

Exclusion Criteria:

1. Pregnancy;

2. Chronic kidney disease (CKD stage 5);

3. Senile dementia patients;

4. With malignant tumor;

5. Moderate and severe anemia;

6. Severe liver dysfunction;

7. Hemolytic anemia, aplastic anemia, massive blood loss or transfusion, chronic malaria;

8. In the recent one week, large doses of salicylate, erythropoietin, antiretroviral drugs, ribavirin and other drugs that have an impact on the detection of glycosylated hemoglobin were used

Related Conditions & MeSH terms

• Diabetes Mellitus

Intervention

Behavioral:
• Traditional mode of management
Traditional model management of Diabetes Mellitus patients
• Mobile APP management
Management of diabetic patients with mobile phone APP

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Chongqing Renji Hospital, University of Chinese Academy of Sciences

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from Baseline Glycated hemoglobin at 12 months	Changes of glycated hemoglobin (percentage)before and after management	Month 12
Secondary	Change from Baseline Blood pressure at 12 months	Changes of blood pressure(mmHg) before and after management	Month 12
Secondary	Change from Baseline blood lipid at 12 months	Changes of blood lipid (mmol/L)before and after management	Month 12
Secondary	Change from Baseline Diabetic nephropathy at 12 months	Changes of Diabetic nephropathy(ratio) before and after management	Month 12