Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Remote Monitoring CGM Group | Experimental | 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. |
|
| Blinded CGM Group | No Intervention | Participants wear a blinded CGM during the study period. Values are blinded to study staff, participant, and clinical staff. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Standard of care glucose test | Diagnostic 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | up to 8 days |
| Measure | Description | Time Frame |
|---|---|---|
| Sensitivity of the CGM to Detect Hypoglycemia. | True positive rate. | up to 7 days |
| Specificity of CGM to Detect Hypoglycemic Events | True negative rate |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Laura Nally, MD | Stanford University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Stanford University | Stanford | California | 94305 | United States |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | Blinded CGM Group | Participants wear a blinded CGM during the study period. Values are blinded to study staff, participant, and clinical staff. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
All infants enrolled in the study.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | 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. | Posted | Number | events | up to 8 days |
|
Up to 7 days of life
Sensor sites on infants examined twice daily by research staff and daily chart reviews were performed.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 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. |
Not provided
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Retained sensor wire | Skin and subcutaneous tissue disorders | Systematic Assessment | 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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Laura Nally, MD, Instructor in Pediatrici Endocrinology | Yale University | 9728324734 | laura.nally@yale.edu |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Mar 6, 2019 | Apr 18, 2019 | Prot_SAP_000.pdf |
Not provided
Not provided
Not provided
Not provided
Not provided
| up to 7 days |
| BG001 | Blinded CGM Group | Participants wear a blinded CGM during the study period. Values are blinded to study staff, participant, and clinical staff. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG001 | Blinded CGM Group | Participants wear a blinded CGM during the study period. Values are blinded to study staff, participant, and clinical staff. |
|
|
| Secondary | Sensitivity of the CGM to Detect Hypoglycemia. | True positive rate. | 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. | Posted | Number | % of true hypoglycemic events | up to 7 days |
|
|
|
| Secondary | Specificity of CGM to Detect Hypoglycemic Events | True negative rate | 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. | Posted | Number | % of true negative events | up to 7 days |
|
|
|
| 0 |
| 15 |
| 0 |
| 15 |
| 1 |
| 15 |
| EG001 | Blinded CGM Group | Participants wear a blinded CGM during the study period. Values are blinded to study staff, participant, and clinical staff. | 0 | 6 | 0 | 6 | 0 | 6 |
|
Not provided
Not provided