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The purpose of this prospective observational study is to establish the performance and safety of the Dexcom G6 CGM System utilized for up to a 10-day wear period in pregnant women with diabetes mellitus.
Primary Study Objective:
To determine the accuracy of Dexcom G6 CGM System glucose readings in reference to arterialized venous sample YSI glucose measurements in pregnant women with diabetes mellitus.
Secondary Study Objective:
To assess the safety of the Dexcom G6 CGM System, through characterization of device-related Adverse Events (AEs), in pregnant women with diabetes mellitus.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group | Device: Dexcom CGM System |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dexcom CGM System | Device | Dexcom CGM System |
|
| Measure | Description | Time Frame |
|---|---|---|
| Dexcom G6 CGM Accuracy | Accuracy of Dexcom G6 CGM System glucose readings in reference to arterialized venous sample YSI glucose measurements in pregnant women with diabetes mellitus. | 10 days |
| Measure | Description | Time Frame |
|---|---|---|
| Dexcom G6 CGM Safety | Assess the safety of the Dexcom G6 CGM System, through characterization of device-related Adverse Events (AEs), in pregnant women with diabetes mellitus. | 10 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Cynthia Makady | Contact | 858-200-0272 | cmakady@dexcom.com |
| Name | Affiliation | Role |
|---|---|---|
| Stayce Beck | DexCom, Inc. | Study Director |
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| 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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