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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.
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%\
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Strength group | Experimental | Strengthen self-monitoring of blood glucose by Internet mobile terminal (APP) |
|
| Control group | No Intervention | Voluntary self-monitoring of blood glucose |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Strengthen self-monitoring of blood glucose | Other | Strengthen self-monitoring of blood glucose by Internet mobile terminal（APP）. |
|
| Measure | Description | Time Frame |
|---|---|---|
| absolute change in % HbA1c from baseline to 12 months | absolute change in glycemic control (% HbA1c) from baseline to 12 months | baseline to 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| absolute change in % HbA1c from baseline to 6 months | absolute change in glycemic control (% HbA1c) from baseline to 6 months | baseline to 6 months |
| absolute change in % HbA1c from baseline at 24 months |
| Measure | Description | Time Frame |
|---|---|---|
| mean difference in Health-related Quality of Life Scores from 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. | baseline to 12 months |
| mean difference in Health-related Quality of Life Scores from baseline to 24 months |
Inclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ruijin Hospital North | Shanghai | 201801 | China |
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| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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absolute change in glycemic control (% HbA1c) from baseline to 24 months
| baseline to 24 months |
| change in blood glucose from baseline to 6 month | change in fasting and postprandial blood glucose from baseline to 6 month | baseline to 6 months |
| change in blood glucose from baseline to 12 month | change in fasting and postprandial blood glucose from baseline to 12 month | baseline to 12 months |
| change in blood glucose from baseline to 24 month | change in fasting and postprandial blood glucose from baseline to 24 month | 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. |
| baseline to 24 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 12 months | baseline to 12 months |
| change in urinary albumin-to-creatinine ratio (UACR) from baseline to 24 months | change in urinary albumin-to-creatinine ratio (UACR) from baseline to 24 months | baseline to 24 months |
| number of participants on specified Diabetes medications at baseline and follow-up | 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). | baseline to 12 months |
| number of participants on specified Diabetes medications at baseline and follow-up | 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). | baseline to 24 months |
| change in health economics indexes from 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). | baseline to 12 months |
| change in health economics indexes from 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). | baseline to 24 months |
| D004700 | Endocrine System Diseases |