Efficacy of Continuous Glucose Monitoring in Neonates With Hypoglycemia

Not Applicable

Terminated

Conditions: Hypoglycemia
Newborn Morbidity

Interventions: Device: Continuous Glucose Monitoring

Registration Number: NCT02300285

Lead Sponsor: Boston Children's Hospital

Brief Summary: Our aim is to determine the feasibility of using continuous glucose monitors (CGMs) in infants with low blood glucose to improve how we care for these infants. To do this we plan on monitoring blood glucose levels with CGMs (instead of only with intermittent bloodsampling) in late-preterm and term infants admitted to the NICU who have had hypoglycemia. To see if using CGMs helps us prevent low blood glucose levels and allows us to find a diagnosis and treat sooner, we will randomize patients into one of two groups: a "CGM group" where the CGM information is made available to the NICU team and a "Standard of Care" group where the CGM information will only be available to the research team. However, if infants in the "Standard of Care" group are noted to have three unrecognized severe low blood glucose levels then the research team will inform the NICU team that this has occurred.

Detailed Description: We aim to evaluate the utility of continuous glucose monitors (CGMs) in improving the diagnosis and management of neonatal hypoglycemia in infants admitted to the neonatal intensive care unit (NICU). Specifically, we hope to assess whether the use of CGMs in this population reduces the number and severity of hypoglycemic events, reduces the time to diagnosis of the etiology of hypoglycemia and/or reduces the time taken to achieve stable euglycemia on a sustainable feeding regimen. We plan to perform a prospective pilot and feasibility study comparing the clinical course and outcomes of newborns with hypoglycemia admitted to the NICU who are actively monitored with CGMs versus those who receive routine care. Eligible infants will be late preterm and term infants admitted to the Boston Children's Hospital who have had two documented hypoglycemic episodes during their current admission. Families will be approached for consent shortly after diagnosis of recurrent hypoglycemia. As all of these infants will be undergoing periodic blood glucose monitoring as part of their routine care, enrollment in this study will involve minimal additional interventions, including CGM placement, which involves placement of a small subcutaneous needle sensor, and the possibility of drawing additional blood glucose samples if hypoglycemia is detected by CGM. All enrolled infants will be placed on a CGM monitor and then randomized to either the "CGM Protocol" or "Standard of Care" group. Those on the CGM Protocol will have a fully accessible CGM that will be analyzed for blood glucose trends and will alarm for any blood glucose level approaching hypoglycemic threshold (eg. BG \<70 mg/dL). Those in the "Standard of Care" group will have a CGM in place, but values will not be available to the clinical team except if severe hypoglycemia is recorded (eg. BG \<40 mg/dL). Whenever the CGM alarms or there is a concerning blood glucose trend as measured by the CGM, the nurse will be asked to check a blood glucose value. All clinical management decisions will be made by the clinical team based on confirmed blood glucose values. In the control group, the only change to current management is the potential performance of additional blood glucose checks that may be prompted by CGM alarms for severe hypoglycemia. The CGM will remain in place until the infant is no longer being monitored for glycemic stability or the infant is discharged. We will record all blood glucose levels, laboratory data related to investigation of the underlying cause of hypoglycemia, all intravenous and enteral sources of glucose, and uses of other therapeutic interventions such as diazoxide and carnitine replacement. We will also compare blood glucose data with information from the CGM monitors to assess accuracy. We will then compare severity and frequency of hypoglycemia, as well as times to diagnosis and euglycemia between the "CGM" and "Standard of Care" groups.

Recruitment & Eligibility

Status: TERMINATED

Sex: All

Target Recruitment: 6

Inclusion Criteria

Not provided

Exclusion Criteria

Infants with skin disease such that placement of a glucose sensor under the skin would be difficult to secure
Infants expected to remain in NICU less than 24 hours
Infants on a hypothermic protocol
Infants enrolled in a competing clinical trial
Family/team have decided to limit or redirect from aggressive NICU technological support
infants who are wards of the state

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
CGM Protocol	Continuous Glucose Monitoring	Subjects will receive continuous glucose monitoring and caregivers will be able to view continuous glucose measurements.
Standard of Care	Continuous Glucose Monitoring	Subjects will receive continuous glucose monitoring but caregivers will not be able to view continuous glucose measurements.

Primary Outcome Measures

Name	Time	Method
Frequency of Hypoglycemic Events	Up to 28 days	Hypoglycemia is defined by age group: for patients less than 48 hours of life, hypoglycemia is defined as glucose level \< 50 mg/dL for patients greater than or equal to 48 hours of life it is defined as glucose level \< 70 mg/dL.
Frequency of Severe Hypoglycemia Events	Up to 28 days	Severe hypoglycemia is defined as glucose level \< 40 mg/dL

Secondary Outcome Measures

Name	Time	Method
Number of Events Where Etiology of Hypoglycemia Was Established	up tp 28 days	Diagnosis of the etiology of hypoglycemia, and the time to to do, will be evaluated in order to determine if the use of CGM will prompt earlier testing to evaluate the etiology of the hypoglycemia and therefore lead to earlier ascertainment of the underlying etiology. Diagnosis of etiology.
Time to Diagnosis of Etiology of Hypoglycemia	Up to 28 days	Diagnosis of the etiology of hypoglycemia, and the time to to do, will be evaluated in order to determine if the use of CGM will prompt earlier testing to evaluate the etiology of the hypoglycemia and therefore lead to earlier ascertainment of the underlying etiology. Time to diagnosis of etiology.
Time to Stable Euglycemia	Up to 28 days