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Premix insulin is widely used, with high proportion of positive insulin autoimmune antibody in patients with type 2 diabetes. The positive insulin autoimmune antibody may affect blood glucose control. We aim to explore the management for the positive insulin autoimmune antibody and blood glucose control in these patients, and investigate the immune cells changes with the change of different glucose lowering drugs.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Oral hyppoglycemia drug group | Active Comparator | Oral hyppoglycemia drugs, including metforemin, acarbose, dipeptidyl peptidase 4 inhibitors, or SGLT2-ihibitors, are added to reduce insulin dose. |
|
| GLP-1RA group | Active Comparator | Add GLP-1 receptor agonists to reduce insulin dose. |
|
| long-acting insulin group | Active Comparator | Change premix insulin to long-acting insulin plus oral hyppoglycemia drugs |
|
| Control group | No Intervention | continue the present premix insulin treatment, adjust insulin dose according to the bloog glucose profile in FGM to improve glycemic control. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Add oral hyppoglycemia drug | Other | Oral hypoglycemic drugs with insulin sensitization effect are added, reduce insulin dose according to blood glucose |
|
| Measure | Description | Time Frame |
|---|---|---|
| Insulin autoimmune antibody | The change of insulin autoimmune antibody | 3 month |
| Measure | Description | Time Frame |
|---|---|---|
| HbA1c | The change of glycated hemoglobin | 3 month |
| Time in range | The change of time in range | 3 month |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jianhua Ma, Professor | Contact | +862552887091 | majianhua196503@126.com |
| Name | Affiliation | Role |
|---|---|---|
| Jianhua Ma, Professor | The First Affiliated Hospital with Nanjing Medical University | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Nanjing First Hospital, Nanjing Medical Univesity | Recruiting | Nanjing | China |
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| Add GLP-1 receptor agonist | Other | Add GLP-1 receptor agonist and reduce insulin dose according to blood glucose |
|
| Change insulin | Other | Change premix insulin to long-acting insulin |
|
| Time below range | The change of time below range | 3 month |
| B cell | the change of B cell subsets | 3 month |
| T cell | the change of T cell subsets | 3 month |
| 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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