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Patients with type 2 diabetes who have poor blood glucose control are enrolled to evaluate the efficacy and safety of the HbA1c prediction model for adjust the hypoglycemic treatment regimen, compared with the conventional treatment using self-monitoring blood glucose or glycated albumin.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| HbA1c prediction model group | Experimental | HbA1c was predicted every month based on self-monitoring blood glucose for patients in HbA1c prediction model group. Study physicians adjusted patients' hypoglycemic therapy based on self-monitoring blood glucose records/glycated albumin and predicted HbA1c every month. |
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| Conventional treatment group | No Intervention | Study physicians adjusted patients' hypoglycemic therapy based on self-monitoring blood glucose records/glycated albumin, without predicted HbA1c. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HbA1c prediction | Other | HbA1c prediction model was developed based on fasting capillary blood glucose and postprandial capillary blood glucose from self-monitoring blood glucose. Since HbA1c was measured once every 3 month, self-monitoring blood glucose records were transferred to predicted HbA1c by prediction model every month. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in measured HbA1c from baseline to 24 weeks | 24 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change in measured HbA1c from baseline to 12 weeks | 12 weeks | |
| The percentages of participants with HbA1c less than 7.0% at 12 weeks | 12 weeks | |
| The percentages of participants with HbA1c less than 7.0% at 24 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Zhou Xianghai, Prof. | Contact | 010-88324371 | xianghai_zhou@163.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Peking University People's Hospital | Recruiting | Beijing | Ch | 100044 | 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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|
| 24 weeks |
| Change in weight from baseline to 24 weeks | 24 weeks |
| The rate of severe hypoglycemic events and confirmed hypoglycemic events during the 24 weeks of the study | 24 weeks |
| D004700 | Endocrine System Diseases |