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Glucose monitoring is an important part of self-management for patients with diabetes. The results of glucose monitoring not only help to assess the degree of glucose metabolism disorders in patients, but also help physicians to make clinical decisions and guide patients in self-management. Despite extensive efforts and advances in diabetes management during hospitalization, glucose control after patients is discharged home remains a challenge. This trial aims to explore the effect of real-time continuous glucose monitoring (RT-CGM) system compared to self-monitoring of blood glucose (SMBG) group on glucose and self-efficacy of type 2 diabetes patients treated with insulin after discharge from the hospital.
Glycemic management of patients with diabetes after discharge home is extremely challenging, especially for those requiring insulin therapy. The use of a real-time continuous glucose monitoring (RT-CGM) system may improve glycemic control and self-efficacy in patients with type 2 diabetes treated with insulin after discharge from the hospital.
One hundred and fifty insulin-treated adults with type 2 diabetes were randomly assigned to receive either RT-CGM or self-monitoring of blood glucose (SMBG) at hospital discharge for a 12-week monitoring intervention and a 36-week follow-up.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention group | Experimental | The intervention group (75 cases) will wear real-time CGM to monitor blood glucose for 12 weeks, followed by 36 weeks of follow-up. |
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| Control group | Other | The control group (75 cases) is self-monitored by traditional SMBG for 12 weeks at a frequency of no less than 4 times a week, followed by 36 weeks of follow-up. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| RT-CGM | Device | This group of patients will wear RT-CGM for blood glucose monitoring for three months. |
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| Measure | Description | Time Frame |
|---|---|---|
| Time in range (3.9~10.0mmol/L, %) | Percentage of time within glucose level of 3.9-10.0 mmol/L (70-180 mg/dL) measured by CGM. | 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| HbA1c (%) | Glycated hemoglobin (%) | 4weeks, 8weeks, 12 weeks, 24weeks, 48weeks |
| Time in range (3.9~10.0mmol/L, %) | Percentage of time within glucose level of 3.9-10.0 mmol/L (70-180 mg/dL) measured by CGM. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Shiyun Wang, Dr. | Contact | +86 21 2405 8570 | rhyme2008@alumni.sjtu.edu.cn |
| Name | Affiliation | Role |
|---|---|---|
| Jian Zhou, Dr. | Shanghai 6th People's Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shanghai 6th People's Hospital | Recruiting | Shanghai | Shanghai Municipality | 200233 | 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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| SMBG | Device | This group of patients will use a a fingertip glucose meter for blood glucose monitoring for three months, and the monitoring frequency was not less than 4 times per week. |
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| 4weeks, 8weeks, 24weeks, 48 weeks |
| Time above range (>10.0mmol/L, %) | Percentage of time above glucose level of 10.0 mmol/L (180 mg/dL) measured by CGM. | 4weeks, 8weeks, 12 weeks, 24weeks, 48weeks |
| Time below range (<3.9mmol/L, %) | Percentage of time below glucose level of 3.9 mmol/L (70 mg/dL) measured by CGM. | 4weeks, 8weeks, 12 weeks, 24weeks, 48weeks |
| Coefficient of variation (CV) | Standard deviation divided by mean glucose level measured by CGM. | 4weeks, 8weeks, 12 weeks, 24weeks, 48weeks |
| Standard deviation (SD) | Standard deviation of blood glucose measurements during CGM. | 4weeks, 8weeks, 12 weeks, 24weeks, 48weeks |
| Mean amplitude of glycemic excursions (MAGE) | Mean amplitude of glycemic excursions (MAGE) is the average value of all amplitude of glycemic excursions. | 4weeks, 8weeks, 12 weeks, 24weeks, 48weeks |
| Diabetes management self-efficacy | The Chinese version of Diabetes Management Self-efficacy Scale (DMSES) is used to evaluate the patients' self-efficacy | 4weeks, 8weeks, 12 weeks, 24weeks, 48weeks |
| Diabetes Self Care Activities | The Chinese version of Summary of Diabetes Self Care Activities (SDSCA) is used to evaluate the patients' self-efficacy | 4weeks, 8weeks, 12 weeks, 24weeks, 48weeks |
| D004700 | Endocrine System Diseases |