The Effect of Remote SMBG Combined With the Application of APP on the Improvement of T2DM Management in the Community

Study Overview
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Brief Summary
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To investigate whether strengthen community diabetes patients self-monitoring of blood glucose can improve the patient's blood glucose control under Chinese guidelines for the prevention and treatment of diabetes (CDS 2017) and whether this intervention produces health and economic benefits.

Detailed Description
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This project is a cohort intervention study for randomized controlled trials. Community health service centers are the main body of implementing treatment and community diabetes patients are the objects of intervention. 498 T2DM patients with poor blood glucose control (7%<HbA1c≤9.5%) from 4 different community health service centers will be randomized into two groups (strengthen group and control group). Strengthen self-monitoring of blood glucose by APP is the intervention and its duration is 12 months. Follow-up time of this study is 24 months (12 months after the intervention stopped). The diabetes treatment of patients from both groups follows Chinese guidelines (CDS 2017).

Official Title
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The Effect of Remote Self-monitoring of Blood Glucose (SMBG) Combined With the Promotion and Application of Internet Mobile Terminal (APP) on the Improvement of the Staged Type 2 Diabetes Mellitus (T2DM) Management and the Success Rate of Blood Glucose in the Community

Conditions
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Diabetes Mellitus, Type 2

Intervention / Treatment
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* Other: Strengthen self-monitoring of blood glucose


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Diagnosis of type 2 Diabetes Between 18 and 79 years old 7.0%<HbA1c ≤ 9.5% Routinely uses a smart phone Capability of operating the designated APP Long-time residents in Jiading District, Shanghai, China Subordinated to Shanghai medical insurance Contracted residents of community in Jiading District, Shanghai, China Being cognitively able to participate Provision of written informed consent Exclusion Criteria: Type 1 diabetes, gestational diabetes mellitus or other types of diabetes mellitus Currently pregnant or contemplating pregnancy within the next 24 months Lactating women Was not able to insist until the end (24 months) Cognitive impairment Migrant population

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 79 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: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Strength group<br>Strengthen self-monitoring of blood glucose by Internet mobile terminal (APP) | Other: Strengthen self-monitoring of blood glucose<br>* Strengthen self-monitoring of blood glucose by Internet mobile terminal（APP）.<br>|
| No Intervention: Control group<br>Voluntary self-monitoring of blood glucose | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| absolute change in % HbA1c from baseline to 12 months | absolute change in glycemic control (% HbA1c) from baseline to 12 months | baseline to 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| absolute change in % HbA1c from baseline to 6 months | absolute change in glycemic control (% HbA1c) from baseline to 6 months | baseline to 6 months | 
| absolute change in % HbA1c from baseline at 24 months | absolute change in glycemic control (% HbA1c) from baseline to 24 months | baseline to 24 months | 
| change in blood glucose from baseline to 6 month | change in fasting and postprandial blood glucose from baseline to 6 month | baseline to 6 months | 
| change in blood glucose from baseline to 12 month | change in fasting and postprandial blood glucose from baseline to 12 month | baseline to 12 months | 
| change in blood glucose from baseline to 24 month | change in fasting and postprandial blood glucose from baseline to 24 month | baseline to 24 months |