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

NCT ID: NCT03588000

Last Updated: 2021-09-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

498 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-11-23

Study Completion Date

2021-04-16

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).

Conditions

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Diabetes Mellitus, Type 2

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Strength group

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

Group Type EXPERIMENTAL

Strengthen self-monitoring of blood glucose

Intervention Type OTHER

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

Control group

Voluntary self-monitoring of blood glucose

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Strengthen self-monitoring of blood glucose

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

Intervention Type OTHER

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

79 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Yuwen Zhang

OTHER

Sponsor Role lead

Responsible Party

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Yuwen Zhang

Principal Investigator

Responsibility Role SPONSOR_INVESTIGATOR

Locations

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Ruijin Hospital North

Shanghai, , China

Site Status

Countries

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China

Other Identifiers

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16CR4020A

Identifier Type: -

Identifier Source: org_study_id

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