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| Name | Class |
|---|---|
| DexCom, Inc. | INDUSTRY |
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Diabetes mellitus (DM) affects roughly 8% of pregnancies and is associated with significant perinatal and maternal morbidity. Current obstetric practice is complicated by the emergence of the SARS-COV-2 pandemic, resulting in morbidity and mortality secondary to complications of COVID-19. Care coordination among the teams caring for women admitted for antepartum, intrapartum, and postpartum care with suspected or confirmed COVID-19 is required to conserve PPE and minimize staff exposure. The investigators propose a pilot proof of concept randomized study to evaluate the utility of Dexcom-G6 continuous glucose monitors for assessment of glycemic control in pregnant and postpartum women with insulin-requiring diabetes mellitus during hospitalizations, as a proof of concept in the efforts to reduce the number of point of care glucose tests needed, reduce staff exposure, and conserve PPE use.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dexcom CGM | Other | Proof of concept randomized study to evaluate the utility of Dexcom-G6 continuous glucose monitors for assessment of glycemic control in pregnant and postpartum women with insulin-requiring diabetes mellitus during hospitalizations |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dexcom G6 | Device | Continuous glucose monitor |
|
| Measure | Description | Time Frame |
|---|---|---|
| Maternal outcomes | Outcomes pertaining to overall maternal health based on glucose control as determined by HbA1c | 1 year |
| Neonatal outcomes | Outcomes pertaining to overall neonatal health based on incidence of neonatal diseases upon birth as determined by a physical exam of the neonate | 1 year |
| Maternal outcomes | Outcomes pertaining to overall maternal health based on glucose control as determined by serum glucose levels | 1 year |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Elizabeth Buschur, MD | Contact | (614) 293-8045 | Elizabeth.Buschur@osumc.edu |
| Name | Affiliation | Role |
|---|---|---|
| Elizabeth Buschur, MD | Ohio State University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Ohio State University Medical Center | Recruiting | Columbus | Ohio | 43210 | United States |
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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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