Detecting Neonatal Hypoglycemia Using Real-Time Continuous Glucose Monitoring (CGM)
| Status: | Completed |
|---|---|
| Conditions: | Endocrine |
| Therapuetic Areas: | Endocrinology |
| Healthy: | No |
| Age Range: | Any |
| Updated: | 5/27/2018 |
| Start Date: | October 1, 2016 |
| End Date: | April 1, 2018 |
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.
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.
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.
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.
We found this trial at
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Stanford University Stanford University, located between San Francisco and San Jose in the heart of...
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