Continuous Glucose Monitoring in HIE

Not Applicable

Recruiting

• Conditions: Hypoglycemia; Hypoxic Ischemic Encephalopathy of Newborn; Hyperglycemia
• Interventions: Device: Dexcom ONE+

• Registration Number: NCT06563687
• Lead Sponsor: University of Campania "Luigi Vanvitelli"

Brief Summary

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.

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 Timeline

• Status Verified: 2024-08
• Study Start: 2024-08-01
• Study First Submitted: 2024-08-14
• Study First Submitted QC: 2024-08-20
• Last Update Submitted: 2024-08-20
• Study First Posted: 2024-08-21
• Last Update Posted: 2024-08-21
• Primary Completion: 2026-08-01
• Study Completion: 2026-12-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 70

Inclusion Criteria

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

Read More

Exclusion Criteria

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

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Blinded CGM	Dexcom ONE+	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.
Experimental: Unblinded CGM	Dexcom ONE+	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.

Primary Outcome Measures

Name	Time	Method
In range - time	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

Secondary Outcome Measures

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

Trial Locations

Locations (3)

A.O.S.G. Moscati; 🇮🇹 Avellino, Italy

Monaldi | | AORN - Ospedali dei ColliAORN - Ospedali dei Colli; 🇮🇹 Naples, Italy

University of Campania Luigi Vanvitelli; 🇮🇹 Napoli, Italy