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

Yuwen Zhang

Status: Completed

Conditions: Diabetes Mellitus, Type 2

Treatments: Other: Strengthen self-monitoring of blood glucose

Study type: Interventional

Funder types: Other

Identifiers

NCT03588000

16CR4020A

Details and patient eligibility

About

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.

Full description

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).

Enrollment: 498 patients

Sex: All

Ages: 18 to 79 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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498 participants in 2 patient groups

Strength group

Experimental group

Description:

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

Treatment:

Other: Strengthen self-monitoring of blood glucose

Control group

No Intervention group

Description:

Voluntary self-monitoring of blood glucose