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

Not Applicable

Completed

• Conditions: Diabetes Mellitus, Type 2
• Interventions: Other: Strengthen self-monitoring of blood glucose

• Registration Number: NCT03588000
• Lead Sponsor: Yuwen Zhang

Brief Summary

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

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 Timeline

• Study First Submitted: 2018-06-07
• Study First Submitted QC: 2018-07-02
• Study First Posted: 2018-07-17
• Study Start: 2018-11-23
• Primary Completion: 2021-02-28
• Study Completion: 2021-04-16
• Status Verified: 2021-09
• Last Update Submitted: 2021-09-20
• Last Update Posted: 2021-09-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 498

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Strength group	Strengthen self-monitoring of blood glucose	Strengthen self-monitoring of blood glucose by Internet mobile terminal (APP)

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
change in blood glucose from baseline to 24 month	baseline to 24 months	change in fasting and postprandial blood glucose from baseline to 24 month
absolute change in % HbA1c from baseline to 6 months	baseline to 6 months	absolute change in glycemic control (% HbA1c) from baseline to 6 months
absolute change in % HbA1c from baseline at 24 months	baseline to 24 months	absolute change in glycemic control (% HbA1c) from baseline to 24 months
change in blood glucose from baseline to 6 month	baseline to 6 months	change in fasting and postprandial blood glucose from baseline to 6 month
change in blood glucose from baseline to 12 month	baseline to 12 months	change in fasting and postprandial blood glucose from baseline to 12 month

Trial Locations

Locations (1)

Ruijin Hospital North; 🇨🇳 Shanghai, China