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The current study will compare the different efficacy of two transient intensive insulin treatment strategies: Continuous subcutaneous insulin infusion (CSII) and multiple daily insulin injections (MDI) in patients who are not well controlled with oral hypoglycaemic agents.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Continuous Subcutaneous Insulin Infusion | Experimental | CSII |
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| Multiple Daily Insulin Injections | Active Comparator | MDI |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Transient Continuous Subcutaneous Insulin Infusion | Drug | Patients will be given Continuous Subcutaneous Insulin Infusion during two weeks confinement in the hospital. The initial dosage will be body weight (kg)*0.5, and will be adjusted according to the 7 points glucose monitoring records in the hospital. |
| Measure | Description | Time Frame |
|---|---|---|
| Glycated hemoglobin levels | The different influence of two intensive insulin treatment strategies: CSII and MDI on the change of glycated hemoglobin levels during two weeks intensive insulin treatment period and 1 year after the intensive treatment. | During 2 weeks intensive insulin treatment period and 1 year after the intensive treatment. |
| Glycated albumin levels | The different influence of two intensive insulin treatment strategies: CSII and MDI on the change of glycated albumin levels during two weeks intensive insulin treatment period and 1 year after the intensive treatment. | During 2 weeks intensive insulin treatment period and 1 year after the intensive treatment. |
| Measure | Description | Time Frame |
|---|---|---|
| The glucose levels | The different influence of CSII and MDI on the change of plasma glucose levels during 2 weeks intensive treatment and 1 year after treatment | During 2 weeks intensive treatment and 1 year after treatment |
| Episode of hypoglycemia |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ruijin hospital, Shanghai Jiao-Tong University School of Medicine | Recruiting | Shanghai | Shanghai Municipality | 200025 | China |
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| Transient Multiple Daily Insulin Injections | Drug | Patients will be given Transient multiple daily insulin injections during two weeks confinement in the hospital. The initial dosage will be body weight (kg)*0.5, and will be adjusted according to the 7 points glucose monitoring records in the hospital |
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The different influence of CSII and MDI on Episode of hypoglycemia during 2 weeks of intensive treatment and 1 year after treatment
| During 2 weeks of intensive treatment and 1 year after treatment |
| Body weight | The different influence of CSII and MDI on Body weight during 2 weeks intensive treatment and 1 year after treatment | During 2 weeks intensive treatment and 1 year after treatment |
| Biochemical parameters and inflammatory factors | The different influence of CSII and MDI on the change of biochemical parameters and inflammatory factors during 2 weeks intensive treatment and 1 year after treatment | During 2 weeks intensive treatment and 1 year after treatment |
| C peptide levels | The different influence of CSII and MDI on the change of C peptide levels during 2 weeks intensive treatment period and 1 year after treatment | During 2 weeks intensive treatment and 1 year after treatment |
| Number of participants with adverse events | The number of Participants with adverse events in different intensive treatment strategies (CSII or MDI) during 2 weeks intensive treatment period and 1 year after treatment. | During 2 weeks intensive treatment and 1 year after treatment |
| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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