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| Name | Class |
|---|---|
| Jaeb Center for Health Research | OTHER |
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The purpose of the study is to examine whether non-adjunctive (without having to double check using another method) use of Continuous Glucose Monitoring improves A1c in adults or children with diabetes managed by intensive insulin therapy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Phase 1 -- Introduction to Dexcom G6 CGM | Other | A 2 week run-in wear period of blinded CGM followed by 12 weeks of wear of a Commercially available CGM |
|
| Phase 2 -- Comparison of an Updated G6 Transmitter to Commercial Dexcom G6 CGM | Active Comparator | 1 group will wear a Commercially available CGM for 12 weeks while the 2 group will wear an Updated CGM for 12 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Phase 1- Introduction to Dexcom G6 CGM | Device | Examine whether non-adjunctive use of CGM improves glycemic control in adults with diabetes managed by intensive insulin therapy |
|
| Measure | Description | Time Frame |
|---|---|---|
| HbA1c | Phase 1 change in HbA1c for the adult cohort only. | 16 weeks |
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Inclusion Criteria
Exclusion Criteria
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Las Vegas Endocrinology | Henderson | Nevada | 89074 | United States |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Aug 28, 2024 | Sep 23, 2024 | 6 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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The study consists of two phases. Phase I is a single-arm, prospective, multicenter, interventional design. Phase II is a randomized controlled arm study during which participants will be randomized 1:1 to Commercial CGM or Updated CGM
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