Continuous Glucose Monitoring and Preterm Infants (CGM&VLBWI)
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|ClinicalTrials.gov Identifier: NCT02583776|
Recruitment Status : Completed
First Posted : October 22, 2015
Last Update Posted : August 10, 2016
Neonatal hypoglycemia is associated with brain injury and impaired neurodevelopment outcomes in very low birth weight infants (VLBWI). Glycemic monitoring is usually performed by capillary or central line sampling but does not identify up to 81% of hypoglycemic episodes in preterm newborns.
The investigators aim to assess if a continuous glucose monitor (CGM) can be used to maintain euglycemia (defined as a target value 72-144mg/dl) in VLBWI.
It will be enrolled newborns ≤32 weeks gestational age and/or of birthweight ≤1500 g, within 48 hours of life, they will be randomized in two study arms, both them will wear Dexcom G4 Platinum CGM: 1) Unblinded group (UB): glucose daily intake will be modulated according to CGM (Dexcom G4 Platinum) during the first 7 days of life, alarms for hypos/hyper will be active; 2) Blinded group (B), glucose infusion rate will be modified according to 2-3 daily capillary glucose tests, alarms for hypos will be switched off. Pain at insertion will be evaluated with the validated Premature Infant Pain Profile (PIPP) scale.
The estimated numerosity is 50 patients (25 for each arm).
|Condition or disease||Intervention/treatment||Phase|
|Infant, Very Low Birth Weight Neonatal Hypoglycemia||Device: Unblinded - CGM Device: Blinded - CGM||Phase 4|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||50 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||NEONATAL HYPOGLYCEMIA and CONTINUOUS GLUCOSE MONITORING: A RANDOMIZED CONTROLLED TRIAL IN PRETERM INFANTS|
|Study Start Date :||October 2015|
|Actual Primary Completion Date :||April 2016|
|Actual Study Completion Date :||April 2016|
Experimental: Unblinded CGM
CGM data will be "unblinded", with Hypo/hyperglycemia alarms on. Data will be recorded from CGM every three hours and intervention to adequate glucose intake will be performed to keep glycemia in normal range (72-144mg/dl) if necessary.
Device: Unblinded - CGM
Data from device will be readable and alarms on
Hypo/hyper alarms are off. CGM data will be blinded. Glucose intake will be adequate according to 2-3 capillary glycemic tests per day.
Device: Blinded - CGM
Data from device will be blinded and alarms off
- In range - time [ Time Frame: 7 days (minimum 2) ]Percentage of time in range 72-144mg/dl
- Hypoglycemia [ Time Frame: 7days ]percentage of time below 40mg/dl
- Acute event associated to glycemic variability and/or hypoglycemia [ Time Frame: 7days ]Acute events (cerebral hemorrhage) and association with glycemic variability (specific patterns)
- Glycemic variability and hypoglycemia predictors [ Time Frame: 7days ]Evaluation of glycemic variability
- hypoglycemia prediction [ Time Frame: 7days ]Predictors of hypoglycemia: to individuate glycemic patterns/trends that could predict hypoglycemia
- Glycemic modeling [ Time Frame: 7days ]Creation of a glycemic modeling to predict hypoglycemia and to prevent it (see Klonoff DC et al J Diabetes Sci Technol. 2010)
- Pain associated to insertion of CGM respect to Pain associated to heel prick [ Time Frame: 7 days ]PIPP scale will be used to compare CGM vs heel prick in each subject. The scale consists of a numeric score as described by Stevens B (Clin J Pain, 1996)
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): NCT02583776
|United States, Massachusetts|
|Boston Children's Hospital|
|Boston, Massachusetts, United States, MA02215|
|Neonatal Intensive Care Unit - University Hospital of Padua|
|Padua, Italy, 35128|
|Department of Information Engineering - University of Padua|
|Padua, Italy, 35131|
|Principal Investigator:||Alfonso Galderisi, MD||University Hospital of Padua|
|Principal Investigator:||Daniele Trevisanuto, MD||University Hospital of Padua|