Trial Outcomes & Findings for Detecting Neonatal Hypoglycemia Using Real-Time Continuous Glucose Monitoring (CGM) (NCT NCT03032523)
NCT ID: NCT03032523
Last Updated: 2019-07-29
Results Overview
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.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
21 participants
Primary outcome timeframe
up to 8 days
Results posted on
2019-07-29
Participant Flow
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.
Participant milestones
| Measure |
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.
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.
|
Blinded CGM Group
Participants wear a blinded CGM during the study period. Values are blinded to study staff, participant, and clinical staff.
|
|---|---|---|
|
Overall Study
STARTED
|
15
|
6
|
|
Overall Study
COMPLETED
|
12
|
4
|
|
Overall Study
NOT COMPLETED
|
3
|
2
|
Reasons for withdrawal
| Measure |
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.
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.
|
Blinded CGM Group
Participants wear a blinded CGM during the study period. Values are blinded to study staff, participant, and clinical staff.
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
2
|
2
|
|
Overall Study
Physician Decision
|
1
|
0
|
Baseline Characteristics
Detecting Neonatal Hypoglycemia Using Real-Time Continuous Glucose Monitoring (CGM)
Baseline characteristics by cohort
| Measure |
Remote Monitoring CGM Group
n=15 Participants
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.
|
Blinded CGM Group
n=6 Participants
Participants wear a blinded CGM during the study period. Values are blinded to study staff, participant, and clinical staff.
|
Total
n=21 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Customized
Less than 24 hours of life
|
14 Participants
n=39 Participants
|
6 Participants
n=41 Participants
|
20 Participants
n=35 Participants
|
|
Age, Customized
24-48 hours of life
|
1 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
1 Participants
n=35 Participants
|
|
Sex: Female, Male
Female
|
10 Participants
n=39 Participants
|
1 Participants
n=41 Participants
|
11 Participants
n=35 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=39 Participants
|
5 Participants
n=41 Participants
|
10 Participants
n=35 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
6 Participants
n=39 Participants
|
1 Participants
n=41 Participants
|
7 Participants
n=35 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
9 Participants
n=39 Participants
|
5 Participants
n=41 Participants
|
14 Participants
n=35 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
|
Race/Ethnicity, Customized
White
|
8 Participants
n=39 Participants
|
2 Participants
n=41 Participants
|
10 Participants
n=35 Participants
|
|
Race/Ethnicity, Customized
Asian
|
3 Participants
n=39 Participants
|
2 Participants
n=41 Participants
|
5 Participants
n=35 Participants
|
|
Race/Ethnicity, Customized
Pacific Islander
|
0 Participants
n=39 Participants
|
1 Participants
n=41 Participants
|
1 Participants
n=35 Participants
|
|
Race/Ethnicity, Customized
Other
|
4 Participants
n=39 Participants
|
1 Participants
n=41 Participants
|
5 Participants
n=35 Participants
|
|
Region of Enrollment
United States
|
15 participants
n=39 Participants
|
6 participants
n=41 Participants
|
21 participants
n=35 Participants
|
PRIMARY outcome
Timeframe: up to 8 daysPopulation: 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.
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.
Outcome measures
| Measure |
Remote Monitoring CGM Group
n=12 Participants
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.
|
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
Hypo Events Detected by Sensor (not SOC)
|
5 events
|
—
|
|
Sensor-detected Hypoglycemia
Hypo Events Detected by SOC and not sensor
|
1 events
|
—
|
SECONDARY outcome
Timeframe: up to 7 daysPopulation: 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.
True positive rate.
Outcome measures
| Measure |
Remote Monitoring CGM Group
n=12 Participants
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.
|
Blinded CGM Group
Participants wear a blinded CGM during the study period. Values are blinded to study staff, participant, and clinical staff.
|
|---|---|---|
|
Sensitivity of the CGM to Detect Hypoglycemia.
|
86 % of true hypoglycemic events
|
—
|
SECONDARY outcome
Timeframe: up to 7 daysPopulation: 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.
True negative rate
Outcome measures
| Measure |
Remote Monitoring CGM Group
n=12 Participants
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.
|
Blinded CGM Group
Participants wear a blinded CGM during the study period. Values are blinded to study staff, participant, and clinical staff.
|
|---|---|---|
|
Specificity of CGM to Detect Hypoglycemic Events
|
91 % of true negative events
|
—
|
Adverse Events
Remote Monitoring CGM Group
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Blinded CGM Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Remote Monitoring CGM Group
n=15 participants at risk
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.
|
Blinded CGM Group
n=6 participants at risk
Participants wear a blinded CGM during the study period. Values are blinded to study staff, participant, and clinical staff.
|
|---|---|---|
|
Skin and subcutaneous tissue disorders
Retained sensor wire
|
6.7%
1/15 • Number of events 1 • Up to 7 days of life
Sensor sites on infants examined twice daily by research staff and daily chart reviews were performed.
|
0.00%
0/6 • Up to 7 days of life
Sensor sites on infants examined twice daily by research staff and daily chart reviews were performed.
|
Additional Information
Laura Nally, MD, Instructor in Pediatrici Endocrinology
Yale University
Phone: 9728324734
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place