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

Yuwen Zhang498 enrolled

Overview

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.

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).

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

498

Conditions

Diabetes Mellitus, Type 2

Interventions

Strengthen self-monitoring of blood glucoseOTHER

Strengthen self-monitoring of blood glucose by Internet mobile terminal（APP）.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 79 Years

Medical Language ↔ Plain English

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

Locations (1)

Ruijin Hospital North

Shanghai, China

Outcomes

Primary Outcomes

absolute change in % HbA1c from baseline to 12 months

absolute change in glycemic control (% HbA1c) from baseline to 12 months

Time frame: baseline to 12 months

Secondary Outcomes

absolute change in % HbA1c from baseline to 6 months

absolute change in glycemic control (% HbA1c) from baseline to 6 months

Time frame: baseline to 6 months

absolute change in % HbA1c from baseline at 24 months

absolute change in glycemic control (% HbA1c) from baseline to 24 months

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: baseline to 24 months

Data from ClinicalTrials.gov

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