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| Name | Class |
|---|---|
| International Diabetes Center at Park Nicollet | OTHER |
| Abbott Diabetes Care | INDUSTRY |
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The purpose of this study is to evaluate the effectiveness of Self Monitoring of Blood Glucose (SMBG) for clinical decisions related to the management of type 2 diabetes and to determine the benefit of using Continuous Glucose Monitoring (CGM) for clinical diabetes management.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SMBG Only | Active Comparator | You will measure your blood glucose 4 times daily by finger sticks using a blood glucose meter and you will also wear a CGM device. The CGM measurements will be blinded (neither you nor the study doctor will be able to see the CGM measurements until your final study visit). Only your SMBG measurements will be considered to help manage your diabetes. Your medications will be changed or adjusted based on your HbA1c and/or glucose readings with a goal to achieve an HbA1c level of less than 7%. |
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| SMBG and CGM | Active Comparator | You will measure your blood glucose 4 times daily by finger sticks using a blood glucose meter and you will also wear a CGM device. The CGM measurements will be downloaded at each study visit and will be considered along with your SMBG measurements to help manage your diabetes. Your medications will be changed or adjusted based on your HbA1c and/or glucose readings with a goal to achieve an HbA1c level of 7%. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SMBG to guide clinical decisions | Other | The investigator will base clinical decisions on A1c and modal day analysis of SMBG. |
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| Measure | Description | Time Frame |
|---|---|---|
| Evaluate the efficacy of SMBG for clinical decisions related to the management of type 2 diabetes. | Three, six and nine months. |
| Measure | Description | Time Frame |
|---|---|---|
| Determine the incremental benefit of CGM for clinical decision-making. | Three, six and nine months. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Roger S Mazze, PhD | International Diabetes Center at Park Nicollet | Principal Investigator |
| Elinor S Strock, APRN, BC | International Diabetes Center at Park Nicollet | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| International Diabetes Center | Minneapolis | Minnesota | 55416 | United States |
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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 |
|---|---|
| D000095583 | Continuous Glucose Monitoring |
| ID | Term |
|---|---|
| D001774 | Blood Chemical Analysis |
| D019963 | Clinical Chemistry Tests |
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
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| SMBG and CGM | Other | The investigator will base clinical decisions on A1c, modal day analysis of SMBG and CGM data. |
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| D004700 | Endocrine System Diseases |
| D003933 | Diagnosis |
| D003940 | Diagnostic Techniques, Endocrine |
| D008991 | Monitoring, Physiologic |
| D008919 | Investigative Techniques |