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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

Tracking Information
First Submitted Date  ICMJE January 24, 2017
First Posted Date  ICMJE January 26, 2017
Results First Submitted Date  ICMJE March 22, 2019
Results First Posted Date  ICMJE July 29, 2019
Last Update Posted Date July 29, 2019
Actual Study Start Date  ICMJE October 1, 2016
Actual Primary Completion Date April 1, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 26, 2019)
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.
Original Primary Outcome Measures  ICMJE
 (submitted: January 24, 2017)
Hypoglycemic events [ Time Frame: 12 months ]
We will compare the number of hypoglycemic events detected by CGM in the SOC control group versus the real-time remote monitoring group.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 26, 2019)
  • Sensitivity of the CGM to Detect Hypoglycemia. [ Time Frame: up to 7 days ]
    True positive rate.
  • Specificity of CGM to Detect Hypoglycemic Events [ Time Frame: up to 7 days ]
    True negative rate
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Detecting Neonatal Hypoglycemia Using Real-Time Continuous Glucose Monitoring (CGM)
Official Title  ICMJE Detecting Neonatal Hypoglycemia Using Real-Time Continuous Glucose Monitoring (CGM)
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.
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose: Diagnostic
Condition  ICMJE Neonatal Hypoglycemia
Intervention  ICMJE 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.
Study Arms  ICMJE
  • 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.
    Intervention: Diagnostic Test: Standard of care glucose test
  • No Intervention: Blinded CGM Group
    Participants wear a blinded CGM during the study period. Values are blinded to study staff, participant, and clinical staff.
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: July 26, 2019)
21
Original Estimated Enrollment  ICMJE
 (submitted: January 24, 2017)
40
Actual Study Completion Date  ICMJE April 1, 2018
Actual Primary Completion Date April 1, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE up to 7 Days   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03032523
Other Study ID Numbers  ICMJE 36668
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party Laura Nally, Stanford University
Study Sponsor  ICMJE Stanford University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Laura Nally, MD Stanford University
PRS Account Stanford University
Verification Date July 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP