Detecting Neonatal Hypoglycemia Using Real-Time Continuous Glucose Monitoring (CGM)
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|ClinicalTrials.gov Identifier: NCT03032523|
Recruitment Status : Completed
First Posted : January 26, 2017
Results First Posted : July 29, 2019
Last Update Posted : July 29, 2019
|Condition or disease||Intervention/treatment||Phase|
|Neonatal Hypoglycemia||Diagnostic Test: Standard of care glucose test||Not Applicable|
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 :||Interventional (Clinical Trial)|
|Actual Enrollment :||21 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Care Provider, Outcomes Assessor)|
|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|
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.
- 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.
- 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
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
|United States, California|
|Stanford, California, United States, 94305|
|Principal Investigator:||Laura Nally, MD||Stanford University|