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| Name | Class |
|---|---|
| DexCom, Inc. | INDUSTRY |
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The purpose of this study is to employ continuous glucose monitoring to measure glucose profiles in newborn infants.
We will place a continuous glucose monitor on the infant within 2 hours of birth and record blood glucose values every 5 minutes via the monitor; in addition, the infant will receive blood glucose checks via heel stick according to the standard hospital glucose monitoring protocol.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| No increased risk of hypoglycemia | Infants born with no obvious risk factors for hypoglycemia in the neonatal period. |
| |
| Increased risk of hypoglycemia | Infants considered at increased risk for hypoglycemia after birth including the following criteria:
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dexcom continuous glucose monitor | Device | Measurement of interstitial glucose |
|
| Measure | Description | Time Frame |
|---|---|---|
| Time spent with glucose <40 mg/dL | The Dexcom continuous glucose monitors measure interstitial fluid glucose values every 5 minutes. Data obtained from the Dexcom tracings will allow us to quantify how much time both infants with no risk for hypoglycemia (defined here as <40 mg/dL) and those with risk factors for hypoglycemia spend at a blood glucose of <40 mg/dL. | The device will be worn from about 2 hours after birth until hospital discharge, up to a maximum of 10 days. It will be removed sooner if required for medical care or if the parent requests removal. |
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Inclusion Criteria:
Exclusion Criteria:
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Mother/infant dyads will be admitted at UCSD Jacobs Medical Center for antepartum and postpartum care.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Valentina Stanley, BS | Contact | (858) 249-5985 | vstanley@health.ucsd.edu | |
| Jane Kim, MD | Contact | (858) 966-4032 |
| Name | Affiliation | Role |
|---|---|---|
| Jane Kim, MD | University of California San Diego/Rady Children's Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UCSD Medical Center | Recruiting | La Jolla | California | 92037 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28364046 | Background | Thompson-Branch A, Havranek T. Neonatal Hypoglycemia. Pediatr Rev. 2017 Apr;38(4):147-157. doi: 10.1542/pir.2016-0063. | |
| 26780301 | Background | Adamkin DH. Neonatal hypoglycemia. Curr Opin Pediatr. 2016 Apr;28(2):150-5. doi: 10.1097/MOP.0000000000000319. |
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| 19952738 | Background | Straussman S, Levitsky LL. Neonatal hypoglycemia. Curr Opin Endocrinol Diabetes Obes. 2010 Feb;17(1):20-4. doi: 10.1097/MED.0b013e328334f061. |