Continous Glucose Monitoring in Neonates at Risk of Hypoglycaemia- a Feasibility Study

The overall aim of this study is to compare and evaluate the feasibility and effectiveness of CGM in clinical care of neonates and increase knowledge of hypoglycemia and neonatal glucose values.

Hypotheses: * CGM detects neonatal hypoglycemia by rapid response to changes in blood glucose levels more effectively than repeated capillary blood sampling

• CGM accurately reflects blood glucose levels within the range relevant for newborn infants. * CGM is safe and easily applied to newborn infants and allows real-time monitoring of tissue glucose levels.

Objective: Examine the feasibility of CGM-device with blood glucose assessments in neonates at risk of hypoglycemia.

• Primary outcome: Hypoglycemic episodes (glucose < 2.6 mmol/L) and rapid changes in glucose values not detected by capillary blood sampling.

Recruitment

• ForCSBSI, recruitment of participants will be carried out at the maternity outpatient clinic at SIHF Lillehammer. In Innlandet Hospital Trust, the vast majority of pregnant women with risk factors of neonatal hypoglycemia are selected for delivery at Lillehammer hospital.

Due to only one sensor available we decided to include 25 neonates in order to test feasibility in a clinical setting.

The CGM-sensor will be applied on the lateral side of the upper thigh within 1 hour after birth. Doctors, midwives and nurses at the maternity ward will be trained in application of the devices and supervision will be offered throughout the entire project whenever requested. Capillary blood glucose measurements, enteral nutrition and other treatments and interventions will follow the standard guideline and procedure recommended by the Norwegian Neonatology Interest group. Exact time points for blood sampling will be registered by the nurse, midwife or parent in a registration form specially designed. Continuous glucose values will be sampled for up to 72 hours. Data will be downloaded from the CGM device storage solution and stored in a secure database. The sensor value will be blinded during sampling time. The neonates will be treated after existing guidelines and all treatment interventions based on standard capillary blood samples. Data from the CGM-devices and capillary blood samples will be analyzed and compared retrospectively.

Sampling and registration of data Capillary blood samples will be analyzed with radiometer technique. Validation will be secured through the ISO-recommendation. Sampling technique will be secured ahead of the project.

Due to the nature of the study and research ethics, the results will be unblinded and episodes of incidentally detected hypoglycemia will be treated according to national guidelines.

The neonate will be monitored for up to 72 hours. Variations in glucose, including rapid drops registered by the CGM-devices will be assessed. This will answer if CGM-sensors have clinically acceptable feasibility in neonates at risk of hypoglycemia, and if episodes of hypoglycemia can be detected earlier with CGM. The nurse or midwife responsible for the baby while admitted to the maternity ward or NICU will be asked to a few questions on clinical observations of symptoms. This will answer if the CGM-sensors are able to detect asymptomatic episodes of hypoglycemia in need of treatment. Number of neonates with registered hypoglycemias, total number of hypoglycemias as well as median and ranges of hypoglycemic values will be assessed. Frequencies of registered hypoglycemic episodes registered will be compared between CGM-devices and blood glucose by suitable statistical methods. Regression analyses will be used to calculate risks of developing hypoglycemia according to CGM or blood glucose testing adjusting for relevant background variables including birth weight, gender, gestational age, risk group for hypoglycemia. Agreement between CGM and blood glucose values will be evaluated.

Inclusion criteria

• LGA, Maternal diabetes (TID and TIID and Gestational diabetes)
• GA>36+6

Exclusion criteria

• SGA, Prematurity, major congenital anomalies, multiple pregnancy and severe asphyxia (Apgar < 5 by 10 min. age).