Efficacy of Continuous Glucose Monitoring in Neonates With Hypoglycemia

NCT02300285 | Terminated Results

• 1 other identifier: IRB-P00014699
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

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.

Conditions

Hypoglycemia; Newborn Morbidity

Outcome Measures

Primary Outcomes (2)

• Frequency of Hypoglycemic Events

  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.

  Up to 28 days

• Frequency of Severe Hypoglycemia Events

  Severe hypoglycemia is defined as glucose level \< 40 mg/dL

  Up to 28 days

Secondary Outcomes (3)

• Number of Events Where Etiology of Hypoglycemia Was Established

  up tp 28 days

• Time to Diagnosis of Etiology of Hypoglycemia

  Up to 28 days

• Time to Stable Euglycemia

  Up to 28 days

Study Arms (2)

CGM Protocol

EXPERIMENTAL

Subjects will receive continuous glucose monitoring and caregivers will be able to view continuous glucose measurements.

Device: Continuous Glucose Monitoring

Standard of Care

PLACEBO COMPARATOR

Subjects will receive continuous glucose monitoring but caregivers will not be able to view continuous glucose measurements.

Device: Continuous Glucose Monitoring

Interventions

Continuous Glucose Monitoring DEVICE

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 team but the medical team will be informed by the researchers if there are multiple unrecognized episodes of severe hypoglycemia.

Also known as: Dexcom G4 Platinum

CGM Protocol; Standard of Care

Eligibility Criteria

• Age: Up to 60 Days
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Boston Children's Hospital: lead

Study Sites (1)

Boston Children's Hospital

Boston, Massachusetts, 02115, United States

Location

Related Publications (3)

• Steil GM, Langer M, Jaeger K, Alexander J, Gaies M, Agus MS. Value of continuous glucose monitoring for minimizing severe hypoglycemia during tight glycemic control. Pediatr Crit Care Med. 2011 Nov;12(6):643-8. doi: 10.1097/PCC.0b013e31821926a5.

  PMID: 21499183 BACKGROUND

• Agus MS, Steil GM, Wypij D, Costello JM, Laussen PC, Langer M, Alexander JL, Scoppettuolo LA, Pigula FA, Charpie JR, Ohye RG, Gaies MG; SPECS Study Investigators. Tight glycemic control versus standard care after pediatric cardiac surgery. N Engl J Med. 2012 Sep 27;367(13):1208-19. doi: 10.1056/NEJMoa1206044. Epub 2012 Sep 7.

  PMID: 22957521 BACKGROUND

• Agus MS, Asaro LA, Steil GM, Alexander JL, Silverman M, Wypij D, Gaies MG; SPECS Investigators. Tight glycemic control after pediatric cardiac surgery in high-risk patient populations: a secondary analysis of the safe pediatric euglycemia after cardiac surgery trial. Circulation. 2014 Jun 3;129(22):2297-304. doi: 10.1161/CIRCULATIONAHA.113.008124. Epub 2014 Mar 26.

  PMID: 24671945 BACKGROUND

MeSH Terms

Conditions

Hypoglycemia

Interventions

Continuous Glucose Monitoring

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Blood Chemical Analysis; Clinical Chemistry Tests; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Diagnostic Techniques, Endocrine; Monitoring, Physiologic; Investigative Techniques

Limitations and Caveats

The trial terminated due to lack of enrollment, thus limited data are available.

Results Point of Contact

• Title: Michael SD Agus, MD
• Organization: Boston Children's Hospital

michael.agus@childrens.harvard..edu

617 355-5849

Study Officials

• Michael Agus, MD

  Boston Children's Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: November 20, 2014
• First Posted: November 25, 2014
• Study Start: February 1, 2015
• Primary Completion: August 30, 2018
• Study Completion: August 30, 2018
• Last Updated: November 1, 2021
• Results First Posted: July 7, 2021

Record last verified: 2021-10

Locations

US (1)