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Published on: February 24, 2023
Validation of the continuous glucose monitoring sensor in preterm infants
K Beardsall1, S Vanhaesebrouck, A L Ogilvy-Stuart
1Department of Paediatrics, University of Cambridge, Cambridge University Hospitals NHS Foundation Trust, Hills Road, UK. kb274@cam.ac.uk
Insights
Continuous glucose monitoring sensors (CGMS) show good correlation with standard devices for monitoring preterm infant glucose levels. While not ideal for single readings, CGMS offers valuable trend data for optimizing glycemic control.
Area of Science:
- Neonatal intensive care
- Endocrinology
- Medical device technology
Background:
- Effective glycemic control is crucial in preterm infants to prevent hyperglycemia and hypoglycemia.
- Continuous glucose monitoring sensors (CGMS) are increasingly used in pediatric diabetes but have limited data in preterm neonates.
- Assessing CGMS accuracy over prolonged periods and across glucose ranges is essential.
Purpose of the Study:
- To evaluate the accuracy of CGMS in preterm infants across the full glucose profile.
- To determine if CGMS accuracy deteriorates over a 7-day monitoring period.
- To compare CGMS data with simultaneous point-of-care glucose measurements.
Main Methods:
- Prospective collection of CGMS data from the NIRTURE Trial.
- Comparison of CGMS data with simultaneous point-of-care glucose monitor readings.
- Analysis using Bland Altman, Error Grid, and American Diabetes Association consensus criteria.
Main Results:
- CGMS data showed strong correlation (r=0.94) with point-of-care devices, with minimal bias.
- The sensor met clinical significance criteria (Clarke Error Grid, Consensus Grid).
- Accuracy for detecting specific hypoglycemia or hyperglycemia thresholds was poor; no deterioration over time was observed.
Conclusions:
- CGMS provides valuable trend information for glucose control in preterm infants.
- CGMS can guide the need for blood glucose assessment, aiding in glycemic optimization.
- The study supports the potential utility of CGMS in managing preterm infant glucose levels.
Objective:
Recent studies have highlighted the need for improved methods of monitoring glucose control in intensive care to reduce hyperglycaemia, without increasing the risk of hypoglycaemia. Continuous glucose monitoring is increasingly used in children with diabetes, but there are little data regarding its use in the preterm infant, particularly at extremes of glucose levels and over prolonged periods. This study aimed to assess the accuracy of the continuous glucose monitoring sensor (CGMS) across the glucose profile, and to determine whether there was any deterioration over a 7 day period.
Design:
Prospectively collected CGMS data from the NIRTURE Trial was compared with the data obtained simultaneously using point of care glucose monitors.
Setting:
An international multicentre randomised controlled trial.
Patients:
One hundred and eighty-eight very low birth weight control infants.
Outcome Measures:
Optimal accuracy, performance goals (American Diabetes Association consensus), Bland Altman, Error Grid analyses and accuracy.
Results:
The mean (SD) duration of CGMS recordings was 156.18 (29) h (6.5 days), with a total of 5207 paired glucose levels. CGMS data correlated well with point of care devices (r=0.94), with minimal bias. It met the Clarke Error Grid and Consensus Grid criteria for clinical significance. Accuracy of single readings to detect set thresholds of hypoglycaemia, or hyperglycaemia was poor. There was no deterioration over time from insertion.
Conclusions:
CGMS can provide information on trends in glucose control, and guidance on the need for blood glucose assessment. This highlights the potential use of CGMS in optimising glucose control in preterm infants.
