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Detecting Neonatal Hypoglycemia Using Real-Time Continuous Glucose Monitoring (CGM)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03032523
Recruitment Status : Completed
First Posted : January 26, 2017
Results First Posted : July 29, 2019
Last Update Posted : July 29, 2019
Sponsor:
Information provided by (Responsible Party):
Laura Nally, Stanford University

Brief Summary:
Hypoglycemia is the most common metabolic problem faced after birth. The investigators will be studying the utility of using a continuous glucose monitoring(CGM) system to more closely monitor low blood sugars in newborns. The investigators will evaluate the number of hypoglycemic events detected using CGM and compare it to those detected using current standard of care screening methods.

Condition or disease Intervention/treatment Phase
Neonatal Hypoglycemia Diagnostic Test: Standard of care glucose test Not Applicable

Detailed Description:

A CGM will be subcutaneously inserted by trained staff on a healthy area of skin and will be calibrated according to the manufacturer's instructions. Blood glucose measurements will be taken using a blinded study glucometer to calibrate the device. Calibration by trained study staff will take place about every 12 hours. Sensor insertion sites will be monitored for infection throughout the course of the study by nursing and clinical staff or by trained study staff on an as needed basis. At the conclusion of the study, the CGM will be removed and assessed for signs of infection. Study duration will be up to 7 days while the patient is admitted to the hospital.

Participants will be randomized into 2 groups. The control group will have a blinded CGM in place for the duration of the study. The remote monitoring group will be blinded to clinical staff. This group will have a CGM connected to an iPod that sends continuous glucose data to the study phone and will be monitored 24/7 by study staff. If a blood sugar level of <46 mg/dl is detected, the infant will first be evaluated for positioning that could be causing a falsely low value. If the infant is re-positioned and CGM continues to show a blood sugar level of <46 mg/dl, study staff will prompt the nurse taking care of the patient to obtain a capillary glucose value to verify the low blood sugar and treat it as deemed appropriate by the clinical team.

The investigators will evaluate the number of hypoglycemic events that occur in the blinded CGM group versus the number that occur in the remote monitoring group to assess if the CGM is able to more sensitively detect low blood sugars in infants than current hospital standard of care measures.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 21 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose: Diagnostic
Official Title: Detecting Neonatal Hypoglycemia Using Real-Time Continuous Glucose Monitoring (CGM)
Actual Study Start Date : October 1, 2016
Actual Primary Completion Date : April 1, 2018
Actual Study Completion Date : April 1, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hypoglycemia
Drug Information available for: Dextrose

Arm Intervention/treatment
Experimental: Remote Monitoring CGM Group
Participants wear a CGM that is blinded at bedside (to participant and clinical staff) but remotely monitored by study staff. If a blood sugar less than 46 mg/dl occurs, the study staff receive a notification and ask the clinical staff to perform a confirmation standard of care glucose test.
Diagnostic Test: Standard of care glucose test
If the CGM in the remote monitoring group detects a blood sugar less than 46mg/dl, a confirmatory standard of care glucose test will be performed to confirm the low blood sugar.

No Intervention: Blinded CGM Group
Participants wear a blinded CGM during the study period. Values are blinded to study staff, participant, and clinical staff.



Primary Outcome Measures :
  1. Sensor-detected Hypoglycemia [ Time Frame: up to 8 days ]
    Reported values in the table represent the cumulative number of hypoglycemic events detected by the sensor that were not detected by the hospital standard of care measures across all participants.


Secondary Outcome Measures :
  1. Sensitivity of the CGM to Detect Hypoglycemia. [ Time Frame: up to 7 days ]
    True positive rate.

  2. Specificity of CGM to Detect Hypoglycemic Events [ Time Frame: up to 7 days ]
    True negative rate



Information from the National Library of Medicine

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Ages Eligible for Study:   up to 7 Days   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Infants who are at least 34 weeks gestation that are born to mothers with gestational or pre-gestational diabetes and are admitted to LPCH are eligible for the study.

Exclusion Criteria:

  • Infants <2,000 grams will be excluded from the study. Infants will also be excluded if they have an anomaly of the skin or subcutaneous tissue that would prevent proper adhesion, placement, and function of the sensor.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03032523


Locations
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United States, California
Stanford University
Stanford, California, United States, 94305
Sponsors and Collaborators
Stanford University
Investigators
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Principal Investigator: Laura Nally, MD Stanford University
  Study Documents (Full-Text)

Documents provided by Laura Nally, Stanford University:
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Responsible Party: Laura Nally, Principal Investigator, Stanford University
ClinicalTrials.gov Identifier: NCT03032523    
Other Study ID Numbers: 36668
First Posted: January 26, 2017    Key Record Dates
Results First Posted: July 29, 2019
Last Update Posted: July 29, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Additional relevant MeSH terms:
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Hypoglycemia
Glucose Metabolism Disorders
Metabolic Diseases