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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

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Care Provider, Outcomes Assessor);   Primary Purpose: Diagnostic
Condition Neonatal Hypoglycemia
Intervention Diagnostic Test: Standard of care glucose test
Enrollment 21
Recruitment Details Mothers attending obstetrics clinics at Stanford University were approached if they met inclusion criteria. 119 mothers were approached, 66 declined to participate, 23 were lost to follow up after initially discussing the study, 6 were unable to participate because research staff were not available at the time of birth, and 3 were ineligible.
Pre-assignment Details  
Arm/Group Title Remote Monitoring CGM Group Blinded CGM Group
Hide Arm/Group Description

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.

Standard of care glucose test: If the CGM in the remote monitoring group detects a blood sugar less than 45 mg/dl, a confirmatory standard of care glucose test will be performed to confirm the low blood sugar.

Participants wear a blinded CGM during the study period. Values are blinded to study staff, participant, and clinical staff.
Period Title: Overall Study
Started 15 6
Completed 12 4
Not Completed 3 2
Reason Not Completed
Withdrawal by Subject             2             2
Physician Decision             1             0
Arm/Group Title Remote Monitoring CGM Group Blinded CGM Group Total
Hide Arm/Group Description

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.

Standard of care glucose test: If the CGM in the remote monitoring group detects a blood sugar less than 45 mg/dL, a confirmatory standard of care glucose test will be performed to confirm the low blood sugar.

Participants wear a blinded CGM during the study period. Values are blinded to study staff, participant, and clinical staff. Total of all reporting groups
Overall Number of Baseline Participants 15 6 21
Hide Baseline Analysis Population Description
All infants enrolled in the study.
Age, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 15 participants 6 participants 21 participants
Less than 24 hours of life
14
  93.3%
6
 100.0%
20
  95.2%
24-48 hours of life
1
   6.7%
0
   0.0%
1
   4.8%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 15 participants 6 participants 21 participants
Female
10
  66.7%
1
  16.7%
11
  52.4%
Male
5
  33.3%
5
  83.3%
10
  47.6%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 15 participants 6 participants 21 participants
Hispanic or Latino
6
  40.0%
1
  16.7%
7
  33.3%
Not Hispanic or Latino
9
  60.0%
5
  83.3%
14
  66.7%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 15 participants 6 participants 21 participants
White
8
  53.3%
2
  33.3%
10
  47.6%
Asian
3
  20.0%
2
  33.3%
5
  23.8%
Pacific Islander
0
   0.0%
1
  16.7%
1
   4.8%
Other
4
  26.7%
1
  16.7%
5
  23.8%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 15 participants 6 participants 21 participants
15 6 21
1.Primary Outcome
Title Sensor-detected Hypoglycemia
Hide Description 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.
Time Frame up to 8 days
Hide Outcome Measure Data
Hide Analysis Population Description
Participants in the remote monitoring group were eligible for analysis. 3 were excluded from the remote monitoring group for the analysis. Blinded CGM participants did not have a verification glucose check, thus sensor-detected hypoglycemia was not verified, and thus were not reported in the analysis.
Arm/Group Title Remote Monitoring CGM Group Blinded CGM Group
Hide Arm/Group Description:

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.

Standard of care glucose test: If the CGM in the remote monitoring group detects a blood sugar less than 45mg/dl, a confirmatory standard of care glucose test will be performed to confirm the low blood sugar.

Participants wear a blinded CGM during the study period. Values are blinded to study staff, participant, and clinical staff.
Overall Number of Participants Analyzed 12 0
Measure Type: Number
Unit of Measure: events
Hypo Events Detected by Sensor (not SOC) 5
Hypo Events Detected by SOC and not sensor 1
2.Secondary Outcome
Title Sensitivity of the CGM to Detect Hypoglycemia.
Hide Description True positive rate.
Time Frame up to 7 days
Hide Outcome Measure Data
Hide Analysis Population Description
Participants in the Remote Monitoring CGM Group were analyzed. 3 were excluded from the remote monitoring group for the analysis. Those in the blinded group were unable to be analyzed because the CGM was blinded and did not prompt a BG check.
Arm/Group Title Remote Monitoring CGM Group Blinded CGM Group
Hide Arm/Group Description:

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.

Standard of care glucose test: If the CGM in the remote monitoring group detects a blood sugar less than 45 mg/dl, a confirmatory standard of care glucose test will be performed to confirm the low blood sugar.

Participants wear a blinded CGM during the study period. Values are blinded to study staff, participant, and clinical staff.
Overall Number of Participants Analyzed 12 0
Measure Type: Number
Unit of Measure: % of true hypoglycemic events
86
3.Secondary Outcome
Title Specificity of CGM to Detect Hypoglycemic Events
Hide Description True negative rate
Time Frame up to 7 days
Hide Outcome Measure Data
Hide Analysis Population Description
12 participants had sensor data for analysis. 3 were excluded from the remote monitoring group for the analysis. Blinded CGM participants did not have a verification glucose check, thus specificity could not be calculated on these participants.
Arm/Group Title Remote Monitoring CGM Group Blinded CGM Group
Hide Arm/Group Description:

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.

Standard of care glucose test: If the CGM in the remote monitoring group detects a blood sugar less than 45mg/dl, a confirmatory standard of care glucose test will be performed to confirm the low blood sugar.

Participants wear a blinded CGM during the study period. Values are blinded to study staff, participant, and clinical staff.
Overall Number of Participants Analyzed 12 0
Measure Type: Number
Unit of Measure: % of true negative events
91
Time Frame Up to 7 days of life
Adverse Event Reporting Description Sensor sites on infants examined twice daily by research staff and daily chart reviews were performed.
 
Arm/Group Title Remote Monitoring CGM Group Blinded CGM Group
Hide Arm/Group Description

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 45 mg/dl occurs, the study staff receive a notification and ask the clinical staff to perform a confirmation standard of care glucose 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.

Participants wear a blinded CGM during the study period. Values are blinded to study staff, participant, and clinical staff.
All-Cause Mortality
Remote Monitoring CGM Group Blinded CGM Group
Affected / at Risk (%) Affected / at Risk (%)
Total   0/15 (0.00%)      0/6 (0.00%)    
Hide Serious Adverse Events
Remote Monitoring CGM Group Blinded CGM Group
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/15 (0.00%)      0/6 (0.00%)    
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Remote Monitoring CGM Group Blinded CGM Group
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   1/15 (6.67%)      0/6 (0.00%)    
Skin and subcutaneous tissue disorders     
Retained sensor wire  [1]  1/15 (6.67%)  1 0/6 (0.00%)  0
Indicates events were collected by systematic assessment
[1]
One infant retained the sensor wire upon removal of the sensor, which is a very rare, but known risk. No medical intervention related to the retained sensor wire was required.
Because we were unable to recruit 40 infants during the time frame of the randomized trial, we modified the study design to test the additional benefit of using CGM monitoring to detect hypoglycemia.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Laura Nally, MD, Instructor in Pediatrici Endocrinology
Organization: Yale University
Phone: 9728324734
EMail: laura.nally@yale.edu
Layout table for additonal information
Responsible Party: Laura Nally, Stanford University
ClinicalTrials.gov Identifier: NCT03032523    
Other Study ID Numbers: 36668
First Submitted: January 24, 2017
First Posted: January 26, 2017
Results First Submitted: March 22, 2019
Results First Posted: July 29, 2019
Last Update Posted: July 29, 2019