Diabetes Mellitus, Type 2 Clinical Trial
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
Verified date | September 2021 |
Source | Ruijin Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 498 |
Est. completion date | April 16, 2021 |
Est. primary completion date | February 28, 2021 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 79 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
China | Ruijin Hospital North | Shanghai |
Lead Sponsor | Collaborator |
---|---|
Yuwen Zhang |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | 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 | |
Other | mean difference in Health-related Quality of Life Scores from 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 | |
Other | 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 | |
Other | 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 | |
Other | 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, a-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 | |
Other | 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, a-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 | |
Other | 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, a-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 | |
Other | 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, a-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 | |
Primary | absolute change in % HbA1c from baseline to 12 months | absolute change in glycemic control (% HbA1c) from baseline to 12 months | baseline to 12 months | |
Secondary | absolute change in % HbA1c from baseline to 6 months | absolute change in glycemic control (% HbA1c) from baseline to 6 months | baseline to 6 months | |
Secondary | absolute change in % HbA1c from baseline at 24 months | absolute change in glycemic control (% HbA1c) from baseline to 24 months | baseline to 24 months | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 |
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