Neonatal Hypoglycemia
Conditions
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.
Interventions
DIAGNOSTIC_TESTStandard 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.
Sponsors
Stanford University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
No minimum to 7 Days
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Sensor-detected Hypoglycemia | 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
| Measure | Time frame | Description |
|---|---|---|
| Sensitivity of the CGM to Detect Hypoglycemia. | up to 7 days | True positive rate. |
| Specificity of CGM to Detect Hypoglycemic Events | up to 7 days | True negative rate |
Countries
United States
Participant flow
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.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 15 |
| Blinded CGM Group Participants wear a blinded CGM during the study period. Values are blinded to study staff, participant, and clinical staff. | 6 |
| Total | 21 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Physician Decision | 1 | 0 |
| Overall Study | Withdrawal by Subject | 2 | 2 |
Baseline characteristics
| Characteristic | Total | Remote Monitoring CGM Group | Blinded CGM Group |
|---|---|---|---|
| Age, Customized 24-48 hours of life | 1 Participants | 1 Participants | 0 Participants |
| Age, Customized Less than 24 hours of life | 20 Participants | 14 Participants | 6 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 7 Participants | 6 Participants | 1 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 14 Participants | 9 Participants | 5 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized Asian | 5 Participants | 3 Participants | 2 Participants |
| Race/Ethnicity, Customized Other | 5 Participants | 4 Participants | 1 Participants |
| Race/Ethnicity, Customized Pacific Islander | 1 Participants | 0 Participants | 1 Participants |
| Race/Ethnicity, Customized White | 10 Participants | 8 Participants | 2 Participants |
| Region of Enrollment United States | 21 participants | 15 participants | 6 participants |
| Sex: Female, Male Female | 11 Participants | 10 Participants | 1 Participants |
| Sex: Female, Male Male | 10 Participants | 5 Participants | 5 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 15 | 0 / 6 |
| other Total, other adverse events | 1 / 15 | 0 / 6 |
| serious Total, serious adverse events | 0 / 15 | 0 / 6 |
Outcome results
Primary
Sensor-detected Hypoglycemia
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
Population: 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 | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Remote Monitoring CGM Group | Sensor-detected Hypoglycemia | Hypo Events Detected by Sensor (not SOC) | 5 events |
| Remote Monitoring CGM Group | Sensor-detected Hypoglycemia | Hypo Events Detected by SOC and not sensor | 1 events |
Secondary
Sensitivity of the CGM to Detect Hypoglycemia.
True positive rate.
Time frame: up to 7 days
Population: 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 | Measure | Value (NUMBER) |
|---|---|---|
| Remote Monitoring CGM Group | Sensitivity of the CGM to Detect Hypoglycemia. | 86 % of true hypoglycemic events |
Secondary
Specificity of CGM to Detect Hypoglycemic Events
True negative rate
Time frame: up to 7 days
Population: 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 | Measure | Value (NUMBER) |
|---|---|---|
| Remote Monitoring CGM Group | Specificity of CGM to Detect Hypoglycemic Events | 91 % of true negative events |