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
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Diabetes Mellitus, Type 2
- Sponsor
- Yuwen Zhang
- Enrollment
- 498
- Locations
- 1
- Primary Endpoint
- absolute change in % HbA1c from baseline to 12 months
- Status
- Completed
- Last Updated
- 4 years ago
Overview
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).
Investigators
Yuwen Zhang
Principal Investigator
Ruijin Hospital
Eligibility Criteria
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
Outcomes
Primary Outcomes
absolute change in % HbA1c from baseline to 12 months
Time Frame: baseline to 12 months
absolute change in glycemic control (% HbA1c) from baseline to 12 months
Secondary Outcomes
- change in blood glucose from baseline to 24 month(baseline to 24 months)
- absolute change in % HbA1c from baseline to 6 months(baseline to 6 months)
- absolute change in % HbA1c from baseline at 24 months(baseline to 24 months)
- change in blood glucose from baseline to 6 month(baseline to 6 months)
- change in blood glucose from baseline to 12 month(baseline to 12 months)