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

Study Overview
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Brief Summary
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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.

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

Conditions
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Diabetes Mellitus

Intervention / Treatment
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* Behavioral: Traditional mode of management
* Behavioral: Mobile APP management


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Clinical diagnosis of type 2 diabetes. Aged 18-70; HbA1c ≥ 8.0% Exclusion Criteria: Pregnancy; Chronic kidney disease (CKD stage 5); Senile dementia patients; With malignant tumor; Moderate and severe anemia; Severe liver dysfunction; Hemolytic anemia, aplastic anemia, massive blood loss or transfusion, chronic malaria; 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Mobile app was used for follow-up
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: APP group<br>Participants with diabetes who had access to a mobile APP | Behavioral: Mobile APP management<br>* Management of diabetic patients with mobile phone APP<br>|
| Placebo Comparator: Control Group<br>Diabetes participants who accepted the traditional management model | Behavioral: Traditional mode of management<br>* Traditional model management of Diabetes Mellitus patients<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from Baseline Glycated hemoglobin at 12 months | Changes of glycated hemoglobin （percentage）before and after management | Month 12 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from Baseline Blood pressure at 12 months | Changes of blood pressure（mmHg） before and after management | Month 12 | 
| Change from Baseline blood lipid at 12 months | Changes of blood lipid （mmol/L）before and after management | Month 12 | 
| Change from Baseline Diabetic nephropathy at 12 months | Changes of Diabetic nephropathy（ratio） before and after management | Month 12 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Diabetes Mellitus, Manage, Mobile app