Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Insulin deficiency resulted from progressive beta cell failure and insulin resistance in type 2 diabetes requires exogenous insulin therapy, escaping from oral antihyperglycemic agents. Previous data have been suggested that continuous subcutaneous insulin infusion (CSII) does not only have efficacy in glucose control but also restore beta cell failure.
The investigators plan to compare the efficacy/safety and beta cell function between insulin pump treatment and the intensification of conventional treatment in patients with uncontrolled type 2 diabetes.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Insulin pump | Experimental | insulin pump |
|
| conventional treatment | Active Comparator | intensification of conventional treatment |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| insulin pump | Device | stop any antihyperglycemic medication and convert to insulin pump |
| |
| Measure | Description | Time Frame |
|---|---|---|
| change of HbA1c | 24 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| changes of body weight | 24 weeks | |
| frequency of hypoglycemia | severe hypoglycemia : glucose <40 mg/dl mild hypoglycemia : glucose 40 - 70 mg/dl | 24 weeks |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Soo Bong Choi, MD.PhD | Contact | +82-10-4949-9504 | mellitus@empal.com |
| Name | Affiliation | Role |
|---|---|---|
| Soo Bong Choi, MD.PhD | Konkuk University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Konkuk University Chungju Hospital | Recruiting | Chungju | South Korea |
Not provided
| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D007332 | Insulin Infusion Systems |
| ID | Term |
|---|---|
| D016503 | Drug Delivery Systems |
| D004358 | Drug Therapy |
| D013812 | Therapeutics |
| D007260 | Infusion Pumps |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| conventional treatment |
| Drug |
intensification of conventional treatment by adding oral antihyperglycemic agents or subcutaneous insulin (once / twice/ multiple injection) |
|
| change of beta cell function | insulin secretion-sensitivity index-2 = insulinogenic index x Matsuda index | 24 weeks |
| Percent of patients who reach target goal of HbA1c (<7.0%) | 24 weeks |
| D004700 | Endocrine System Diseases |
| D004864 |
| Equipment and Supplies |
| D001187 | Artificial Organs |
| D013523 | Surgical Equipment |