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Efficacy of Continuous Glucose Monitoring in Neonates With Hypoglycemia

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ClinicalTrials.gov Identifier: NCT02300285
Recruitment Status : Terminated (Insufficient eligible participants to meet recruitment goal)
First Posted : November 25, 2014
Last Update Posted : October 31, 2018
Sponsor:
Information provided by (Responsible Party):
Michael Agus, 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.

Condition or disease Intervention/treatment Phase
Hypoglycemia Newborn Morbidity Device: Continuous Glucose Monitoring Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 6 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Efficacy of Continuous Glucose Monitoring in Neonates With Hypoglycemia
Study Start Date : February 2015
Actual Primary Completion Date : August 30, 2018
Actual Study Completion Date : August 30, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hypoglycemia
Drug Information available for: Dextrose

Arm Intervention/treatment
Experimental: CGM Protocol
Subjects will receive continuous glucose monitoring and caregivers will be able to view continuous glucose measurements.
Device: Continuous Glucose Monitoring
Continuous glucose monitors (CGM) will be used to monitor blood sugar levels in enrolled subjects. CGMs measure blood sugar in the tissue just under the skin every few seconds and report average blood sugar every 5 minutes. In our study, the CGMs will function as monitoring systems. In the CGM protocol group the CGM will let the medical team know if there is a concerning blood sugar level, so that the medical team can then check a blood sugar level by the standard way (usually in a small drop of blood) and then decide if they need to give any medical treatment. In the Standard of Care group the CGM data will not be visible to the medical but the medical team will be informed by the researchers if there are multiple unrecognized episodes of severe hypoglycemia.
Other Name: Dexcom G4 Platinum

Placebo Comparator: Standard of Care
Subjects will receive continuous glucose monitoring but caregivers will not be able to view continuous glucose measurements.
Device: Continuous Glucose Monitoring
Continuous glucose monitors (CGM) will be used to monitor blood sugar levels in enrolled subjects. CGMs measure blood sugar in the tissue just under the skin every few seconds and report average blood sugar every 5 minutes. In our study, the CGMs will function as monitoring systems. In the CGM protocol group the CGM will let the medical team know if there is a concerning blood sugar level, so that the medical team can then check a blood sugar level by the standard way (usually in a small drop of blood) and then decide if they need to give any medical treatment. In the Standard of Care group the CGM data will not be visible to the medical but the medical team will be informed by the researchers if there are multiple unrecognized episodes of severe hypoglycemia.
Other Name: Dexcom G4 Platinum




Primary Outcome Measures :
  1. Frequency and severity of hypoglycemia [ Time Frame: up tp 28 days ]

Secondary Outcome Measures :
  1. Time to diagnosis of etiology of hypoglycemia [ Time Frame: up tp 28 days ]
  2. Time to stable euglycemia [ Time Frame: up tp 28 days ]


Information from the National Library of Medicine

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Ages Eligible for Study:   up to 60 Days   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion criteria:

  • Age 0-60 days old
  • Late-preterm and term infants (babies born more than 33 weeks and 6 days after the start of the pregnancy)
  • History of low blood sugars (hypoglycemia): two episodes of hypoglycemia more than 1 hour apart (low blood sugar will be defined by age: for those less than 48 hours old a low blood sugar is considered less than 50mg/dL and for those older than 48 hours old less than 70mg/dL)

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02300285


Locations
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United States, Massachusetts
Boston Children's Hospital
Boston, Massachusetts, United States, 02115
Sponsors and Collaborators
Boston Children’s Hospital
Investigators
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Principal Investigator: Michael Agus, MD Boston Children’s Hospital