Continuous Glucose Monitoring in HIE

August 20, 2024 updated by: Paolo Montaldo, University of Campania "Luigi Vanvitelli"

Real-time Continuous Glucose Monitoring in Infants With Hypoxic-ischaemic Encephalopathy: a Pilot Randomized Controlled Trial

The aim of the study is to examine whether the use of continuous glucose monitoring (CGM) to guide the clinical management of glycaemic control will result into an increased time in the target glucose concentration. To further examine the efficacy of using CGM the following secondary outcomes in the two groups were assessed: mean glucose values, glucose variability within individuals, percentage of time that glucose values are in hyperglycaemic or hypoglycaemic ranges.

Randomized controlled trial recruiting neonates (Birth weight >1.8kg, Gestation>36 weeks) with moderate or severe hypoxic ischemic encephalopathy (HIE) following perinatal asphyxia . Neonates will be randomly assigned (1:1) within 6 hours of birth to receive either the intervention with real-time CGM or standard care for 72 hours.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Neonatal hypoglycaemia and hyperglycaemia are associated with brain injury and impaired neurodevelopment outcomes in neonates with HIE. Improving early glucose control is an important modifiable risk factor for outcomes in this population. Glycaemic monitoring is usually performed by capillary or central line sampling. However, over 30% of the episodes of abnormal glucose concentration are undetected, even with regular but intermittent sampling. CGM can allow earlier detection and prevention of exposure to extreme glucose concentrations.

Study design - This is a multicentre interventional, open-label, randomized controlled trial of CGM compared with standard clinical management (control).A total of 70 neonates (Birth weight >1.8kg, Gestation >36 weeks and aged <6hours) with moderate or severe HIE following perinatal asphyxia will be recruited within 6 hours of birth after informed parental consent. Neonates with major congenital malformations, inborn errors of metabolism, congenital infections, imminent death will be excluded.

Neonates will be randomly assigned (1:1) to receive either the intervention with real-time CGM for 72 hours or standard care using a randomization program (R package SRS: A Subject Randomization System). We will use the minimization method to control for severity and to achieve balance within recruiting centres. In all the neonates recruited Dexcom ONE+ CGM (Dexcom, San Diego, CA, USA) will be placed soon after study enrollment. The sensors will be inserted in the lateral thigh and continuous measurements will be recorded for 72 h. The CGM device will be calibrated using blood glucose values measured by point-of-care test. CGM calibrations will be performed at least twice a day. CGM data will be downloaded by using Dexcom Studio software on a dedicated computer.

In the standard care group, the CGM device will collect glucose data continuously, but the clinical team will be blinded to the data. These neonates will have their glucose control monitored and managed according to standard clinical practice using intermittently sampled blood glucose levels. In the intervention group the CGM data will be used to support clinical management including blood glucose measurements and decision making. Changes in glucose and insulin infusion will be based primarily on the real-time CGM data but blood glucose concentrations will be checked in case of rapid changes in CGM data.

Interventions to target glucose control will be guided by a protocol shared among the participating hospitals. As part of the study protocol, all the neonates will receive a continuous infusion of glucose 10% of 3-4 mg/kg/minute and total fluid intake starting at 50-60 ml/kg/day followed by titration depending on urine output, renal function, and management of glucose infusion rates.

Study Type

Interventional

Enrollment (Estimated)

70

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Birth weight >1.8kg
  • Gestation >35 weeks
  • Aged <6hours
  • Moderate or severe HIE following perinatal asphyxia

Exclusion Criteria:

  • Major congenital malformations
  • Inborn errors of metabolism,
  • Congenital infections
  • Imminent death

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Experimental: Unblinded CGM
CGM data will be "unblinded", with alarms on for hypo and hyperglycemia. CGM data will be used to support clinical management including blood glucose measurements and decision making. Changes in glucose and insulin infusion will be based primarily on the real-time CGM data but blood glucose concentrations will be checked in case of rapid changes in CGM data or before any treatment.
Device: Dexcom ONE+
In all the neonates recruited CGM sensor and transmitter will be placed soon after study enrollment. The sensors will be inserted in the lateral thigh and continuous measurements will be recorded for all the duration of therapeutic hypothermia.
Other: Blinded CGM
CGM data will be blinded. Alarms for Hypo and hyperglycemia will be off. Glucose control will be monitored and managed according to standard clinical practice using intermittently sampled blood glucose concentrations.
Device: Dexcom ONE+
In all the neonates recruited CGM sensor and transmitter will be placed soon after study enrollment. The sensors will be inserted in the lateral thigh and continuous measurements will be recorded for all the duration of therapeutic hypothermia.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
In range - time
Time Frame: 72 hours after birth
Proportion of time that the sensor glucose values are in the target range (50 to 180 mg/dL) compared between the study groups
72 hours after birth

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Hypoglycemia
Time Frame: 72 hours after birth
Percentage of time below 50 mg/dl
72 hours after birth
Hyperglycemia
Time Frame: 72 hours after birth
Percentage of time above 180 mg/dl
72 hours after birth
Glycemic variability
Time Frame: 72 hours after birth
Evaluation of glycemic variability
72 hours after birth
Adverse events associated to insertion of CGM
Time Frame: up to 10 days after birth
% of infants with adverse events secondary to CGM placement or wear
up to 10 days after birth

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Campania "Luigi Vanvitelli"

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 1, 2024

Primary Completion (Estimated)

August 1, 2026

Study Completion (Estimated)

December 1, 2026

Study Registration Dates

First Submitted

August 14, 2024

First Submitted That Met QC Criteria

August 20, 2024

First Posted (Actual)

August 21, 2024

Study Record Updates

Last Update Posted (Actual)

August 21, 2024

Last Update Submitted That Met QC Criteria

August 20, 2024

Last Verified

August 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SecondUNI84

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Data will be made available when scientific manuscripts are published.

Data that cannot be shared publicly (e.g. to protect patient confidentiality) will be by request only. The PI will review each request on case-by-case basis. Upon approval the data requester will be asked to sign a data sharing agreement.

IPD Sharing Time Frame

The data will be available 1 to 2 years after the end of the study.

IPD Sharing Access Criteria

Unidentified data will be shared by publication. Request for data that affects patient confidentiality will review by the study PI on a case-by-case basis.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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