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

Chongqing Renji Hospital, University of Chinese Academy of Sciences

Status: Unknown

Conditions: Diabetes Mellitus

Treatments: Behavioral: Mobile APP management; Behavioral: Traditional mode of management

Study type: Interventional

Funder types: Other

Identifiers

NCT04999722

2021CQSDWRMYYEC-004

Details and patient eligibility

About

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.

Enrollment: 1,200 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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1,200 participants in 2 patient groups, including a placebo group

APP group

Active Comparator group

Description:

Participants with diabetes who had access to a mobile APP

Treatment:

Behavioral: Mobile APP management

Control Group

Placebo Comparator group

Description:

Diabetes participants who accepted the traditional management model

Treatment:

Behavioral: Traditional mode of management