Diabetes Mellitus, Type 2
Conditions
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).
Interventions
OTHERStrengthen self-monitoring of blood glucose
Strengthen self-monitoring of blood glucose by Internet mobile terminal（APP）.
Sponsors
Yuwen Zhang
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 79 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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 |
Other
| Measure | Time frame | Description |
|---|---|---|
| mean difference in Health-related Quality of Life Scores from baseline to 12 months | baseline to 12 months | change in Short Form-36 (SF-36) subscale scores (Physical and Mental subscales) from baseline to 52 weeks. The SF-36 is a widely used measure of health-related quality of life. |
| change in health economics indexes from baseline to 24 months | baseline to 24 months | health economics indexes assessed by the number of participants taking each of the following medications at baseline and follow-up: insulin, metformin, sulfonylurea, glinides, α-glucosidase inhibitor, glucagon-like peptide-1 (GLP-1), Thiazolidinediones (TZD), dipeptidyl peptidase IV (DPP-IV) and sodium glucose cotransporter-2 (SGLT-2). |
| mean difference in Health-related Quality of Life Scores from baseline to 24 months | baseline to 24 months | change in Short Form-36 (SF-36) subscale scores (Physical and Mental subscales) from baseline to 52 weeks. The SF-36 is a widely used measure of health-related quality of life. |
| change in urinary albumin-to-creatinine ratio (UACR) from baseline to 12 months | baseline to 12 months | change in urinary albumin-to-creatinine ratio (UACR) from baseline to 12 months |
| change in urinary albumin-to-creatinine ratio (UACR) from baseline to 24 months | baseline to 24 months | change in urinary albumin-to-creatinine ratio (UACR) from baseline to 24 months |
| number of participants on specified Diabetes medications at baseline and follow-up | baseline to 12 months | number of participants taking each of the following medications at baseline and follow-up: insulin, metformin, sulfonylurea, glinides, α-glucosidase inhibitor, glucagon-like peptide-1 (GLP-1), Thiazolidinediones (TZD), dipeptidyl peptidase IV (DPP-IV) and sodium glucose cotransporter-2 (SGLT-2). |
| change in health economics indexes from baseline to 12 months | baseline to 12 months | health economics indexes assessed by the number of participants taking each of the following medications at baseline and follow-up: insulin, metformin, sulfonylurea, glinides, α-glucosidase inhibitor, glucagon-like peptide-1 (GLP-1), Thiazolidinediones (TZD), dipeptidyl peptidase IV (DPP-IV) and sodium glucose cotransporter-2 (SGLT-2). |
Countries
China
Outcome results
None listed