Clinical trial NCT03588000: The Effect of Remote SMBG Combined With the Application of APP on the Improvement of T2DM Management in the Community
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes Mellitus, Type 2
Lead sponsor: Ruijin Hospital
Sponsor class: OTHER
First posted: 2018-07-17
Enrollment: 498
Sex: ALL
Minimum age (years): 18
Maximum age (years): 79
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).

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

Primary outcomes:
measure: absolute change in % HbA1c from baseline to 12 months
timeFrame: baseline to 12 months
Secondary outcomes:
measure: absolute change in % HbA1c from baseline to 6 months
timeFrame: baseline to 6 months
measure: absolute change in % HbA1c from baseline at 24 months
timeFrame: baseline to 24 months
measure: change in blood glucose from baseline to 6 month
timeFrame: baseline to 6 months
measure: change in blood glucose from baseline to 12 month
timeFrame: baseline to 12 months
measure: change in blood glucose from baseline to 24 month
timeFrame: baseline to 24 months
Other outcomes:
measure: mean difference in Health-related Quality of Life Scores from baseline to 12 months
timeFrame: baseline to 12 months
measure: mean difference in Health-related Quality of Life Scores from baseline to 24 months
timeFrame: baseline to 24 months
measure: change in urinary albumin-to-creatinine ratio (UACR) from baseline to 12 months
timeFrame: baseline to 12 months
measure: change in urinary albumin-to-creatinine ratio (UACR) from baseline to 24 months
timeFrame: baseline to 24 months
measure: number of participants on specified Diabetes medications at baseline and follow-up
timeFrame: baseline to 12 months
measure: number of participants on specified Diabetes medications at baseline and follow-up
timeFrame: baseline to 24 months
measure: change in health economics indexes from baseline to 12 months
timeFrame: baseline to 12 months
measure: change in health economics indexes from baseline to 24 months
timeFrame: baseline to 24 months
Locations:
city: Shanghai
country: China
facility: Ruijin Hospital North
Study officials:
References: