Continuous Glucose Monitoring in Infants
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ClinicalTrials.gov Identifier: NCT04458649 |
Recruitment Status :
Recruiting
First Posted : July 7, 2020
Last Update Posted : February 1, 2022
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Sponsor:
University of California, San Diego
Collaborator:
DexCom, Inc.
Information provided by (Responsible Party):
Dr Jane Kim, University of California, San Diego
Tracking Information | |||||||||
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First Submitted Date | July 1, 2020 | ||||||||
First Posted Date | July 7, 2020 | ||||||||
Last Update Posted Date | February 1, 2022 | ||||||||
Actual Study Start Date | October 1, 2020 | ||||||||
Estimated Primary Completion Date | September 30, 2023 (Final data collection date for primary outcome measure) | ||||||||
Current Primary Outcome Measures |
Time spent with glucose <40 mg/dL [ Time Frame: 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. ] 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.
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Original Primary Outcome Measures | Same as current | ||||||||
Change History | |||||||||
Current Secondary Outcome Measures | Not Provided | ||||||||
Original Secondary Outcome Measures | Not Provided | ||||||||
Current Other Pre-specified Outcome Measures | Not Provided | ||||||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||||||
Descriptive Information | |||||||||
Brief Title | Continuous Glucose Monitoring in Infants | ||||||||
Official Title | Continuous Glucose Monitoring in Infants | ||||||||
Brief Summary | The purpose of this study is to employ continuous glucose monitoring to measure glucose profiles in newborn infants. | ||||||||
Detailed Description | 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. | ||||||||
Study Type | Observational | ||||||||
Study Design | Observational Model: Cohort Time Perspective: Prospective |
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Target Follow-Up Duration | Not Provided | ||||||||
Biospecimen | Not Provided | ||||||||
Sampling Method | Non-Probability Sample | ||||||||
Study Population | Mother/infant dyads will be admitted at UCSD Jacobs Medical Center for antepartum and postpartum care. | ||||||||
Condition | Neonatal Hypoglycemia | ||||||||
Intervention | Device: Dexcom continuous glucose monitor
Measurement of interstitial glucose
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Study Groups/Cohorts |
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Publications * |
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||||||
Recruitment Status | Recruiting | ||||||||
Estimated Enrollment |
40 | ||||||||
Original Estimated Enrollment | Same as current | ||||||||
Estimated Study Completion Date | September 30, 2023 | ||||||||
Estimated Primary Completion Date | September 30, 2023 (Final data collection date for primary outcome measure) | ||||||||
Eligibility Criteria | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender |
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Ages | up to 2 Hours (Child) | ||||||||
Accepts Healthy Volunteers | Yes | ||||||||
Contacts |
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Listed Location Countries | United States | ||||||||
Removed Location Countries | |||||||||
Administrative Information | |||||||||
NCT Number | NCT04458649 | ||||||||
Other Study ID Numbers | 191263 | ||||||||
Has Data Monitoring Committee | No | ||||||||
U.S. FDA-regulated Product |
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IPD Sharing Statement |
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Current Responsible Party | Dr Jane Kim, University of California, San Diego | ||||||||
Original Responsible Party | Dr Jane Kim, University of California, San Diego, Assistant Clinical Professor | ||||||||
Current Study Sponsor | University of California, San Diego | ||||||||
Original Study Sponsor | Same as current | ||||||||
Collaborators | DexCom, Inc. | ||||||||
Investigators |
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PRS Account | University of California, San Diego | ||||||||
Verification Date | January 2022 |