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| Name | Class |
|---|---|
| Region Skane | OTHER |
| Lund University | OTHER |
| Region Halland | OTHER |
| Västra Götalandsregionen |
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A 26-week, multicenter, parallel two-arm, randomized controlled trial of the glycemic outcomes of individualized treatment support in patients with type 2 diabetes. The primary objective of the trial is to confirm the superiority of standard of care with EASY DSS versus standard of care without EASY DSS in terms of glycemic control in patients with type 2 diabetes with ongoing treatment with any antidiabetic drug(s).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Standard of Care with DSS | Experimental | Patients will receive standard of care with a board certified physician with EASY DSS. The choice of treatment will be made by the investigator. In the investigational arm this will be based on the clinical judgment of the investigator supplemented with support from the EASY DSS and in the control arm this will be based on the clinical judgment of the investigator alone. |
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| Standard of Care without DSS | Active Comparator | Patients will receive standard of care with a board certified physician without EASY DSS. The choice of treatment will be made by the investigator. In the investigational arm this will be based on the clinical judgment of the investigator supplemented with support from the EASY DSS and in the control arm this will be based on the clinical judgment of the investigator alone. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Standard of Care with EASY DSS | Device | The EASY DSS is a software tool designed to process and analyze data to facilitate individualized treatment suggestions for type 2 diabetes patients. Patients will receive standard of care with a board certified physician with EASY DSS. The choice of treatment will be made by the investigator. In the investigational arm this will be based on the clinical judgment of the investigator supplemented with support from the EASY DSS and in the control arm this will be based on the clinical judgment of the investigator alone. |
| Measure | Description | Time Frame |
|---|---|---|
| HbA1c | Change from baseline HbA1c | 26 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Fasting plasma glucose | Change from baseline in fasting plasma glucose (FPG) | 26 weeks |
| Achieving treatment target | Meeting treatment target of HbA1c < 7% (53 mmol/mol) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Damon Tojjar, MD | Lund University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Region Halland | Hålland | Sweden | ||||
| Region Skåne |
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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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| ID | Term |
|---|---|
| D059039 | Standard of Care |
| ID | Term |
|---|---|
| D019984 | Quality Indicators, Health Care |
| D011787 | Quality of Health Care |
| D006298 | Health Services Administration |
| D017530 | Health Care Quality, Access, and Evaluation |
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| OTHER |
Multicenter, randomized controlled trial
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A double-blind design is not feasible due to the need for physicians to use respectively not use the EASY DSS.
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| Standard of Care without EASY DSS | Other | Patients will receive standard of care with a board certified physician without EASY DSS. The choice of treatment will be made by the investigator. In the investigational arm this will be based on the clinical judgment of the investigator supplemented with support from the EASY DSS and in the control arm this will be based on the clinical judgment of the investigator alone. |
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| 26 weeks |
| Hypoglycemia | Meeting treatment target of HbA1c < 7% (53 mmol/mol) without severe or clinically significant hypoglycemic episodes | 26 weeks |
| Skåne |
| Sweden |
| Västra Götalandsregionen | Västra Götaland | Sweden |
| D004700 | Endocrine System Diseases |