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

Chongqing Renji Hospital, University of Chinese Academy of Sciences1,200 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

SINGLE

Enrollment

1,200

Conditions

Diabetes Mellitus

Interventions

Traditional mode of managementBEHAVIORAL

Traditional model management of Diabetes Mellitus patients

Mobile APP managementBEHAVIORAL

Management of diabetic patients with mobile phone APP

Eligibility

Sex: ALLMin age: 18 YearsMax age: 70 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Change from Baseline Glycated hemoglobin at 12 months

Changes of glycated hemoglobin （percentage）before and after management

Time frame: Month 12

Secondary Outcomes

Change from Baseline Blood pressure at 12 months

Changes of blood pressure（mmHg） before and after management

Time frame: Month 12

Change from Baseline blood lipid at 12 months

Changes of blood lipid （mmol/L）before and after management

Time frame: Month 12

Change from Baseline Diabetic nephropathy at 12 months

Changes of Diabetic nephropathy（ratio） before and after management

Time frame: Month 12

Data from ClinicalTrials.gov

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