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| Name | Class |
|---|---|
| Patient-Centered Outcomes Research Institute | OTHER |
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This research trial will randomize 50 primary care clinics and 354 patients in accordance with their primary care clinic assignment to 2 different glucose monitoring strategies (SMBG vs. CGM) and compare the effectiveness through a pragmatic clinic cluster randomized design, with active glycemic management in a "usual" primary care setting, over the course of a 12 month active study period.
The trial will evaluate the comparative effectiveness of SMBG (self-monitoring of blood glucose, also known as blood glucose monitoring [BGM] or fingerstick blood glucose monitoring) vs. continuous glucose monitoring (CGM), in managing glucose levels in individuals with type 2 diabetes (T2D) using insulin, with or without other glycemic therapies, in a primary care setting.
The study will use a 2-arm, parallel group, cluster-randomized trial over a 12-month period. 50 primary care clinics will be randomly assigned to either use SMBG for glucose monitoring (25 clinics), with ongoing glycemic management provided by usual care in primary care, or CGM for glucose monitoring (25 clinics), with ongoing glycemic management provided by usual care in primary care using CGM and Ambulatory Glucose Profile (AGP) reports in a typical clinic setting. The study will use glycemic monitoring devices available to participants using real-world resources to cover the cost of the devices, and will be fundamentally pragmatic in nature.
354 patients (approximately 7/clinic) will be enrolled over 13 months (12 months of active intervention) with an intention-to-treat primary analysis.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CGM (continuous glucose monitoring) | Experimental | Use CGM, with availability of Ambulatory Glucose Profile (AGP) data, to monitor and manage glucose over 12 months, in individuals with type 2 diabetes on insulin with or without other glycemic therapies. Glucose management over the 12 months study period will be in primary care, using "usual care" resources. |
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| SMBG (Self-monitoring of blood glucose) | Active Comparator | Use SMBG, as currently used in primary care, to monitor and manage glucose over 12 months, in individuals with type 2 diabetes on insulin with or without other glycemic therapies. Glucose management over the 12 months study period will be in primary care, using "usual care" resources. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CGM | Other | Continuous glucose monitor (CGM)-based glucose monitoring |
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| Measure | Description | Time Frame |
|---|---|---|
| Change in A1C | To evaluate the effectiveness of two glucose monitoring strategies to reduce A1C levels by measuring differential within-patient change by study arm in A1C (%) from baseline to 12 months. | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Diabetes Distress | To evaluate the effectiveness of two glucose monitoring strategies to reduce diabetes distress by measuring differential within-patient change by study arm in Diabetes Distress Scale scores from baseline to 12 months. | 12 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Richard M Bergenstal, MD | International Diabetes Center, HealthPartners Institute | Principal Investigator |
| Thomas W Martens, MD | International Diabetes Center, HealthPartners Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| International Diabetes Center | Saint Louis Park | Minnesota | 55416 | United States |
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| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| D007333 | Insulin Resistance |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| SMBG | Other | Self-monitoring of blood glucose (SMBG)-based glucose monitoring |
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| D004700 | Endocrine System Diseases |
| D006946 | Hyperinsulinism |