Validation of the continuous glucose monitoring sensor in preterm infants
- K Beardsall1,2,
- S Vanhaesebrouck3,
- A L Ogilvy-Stuart2,
- C Vanhole3,
- M vanWeissenbruch4,
- P Midgley5,
- M Thio6,
- L Cornette7,
- I Ossuetta8,
- C R Palmer9,
- I Iglesias6,
- M de Jong4,
- B Gill7,
- F de Zegher3,
- D B Dunger1
- 1Department of Paediatrics, University of Cambridge, Cambridge University Hospitals NHS Foundation Trust, Hills Road, UK
- 2Neonatal Unit, Cambridge University Hospitals NHS Foundation Trust, Hills Road, UK
- 3Department of Woman and Child, University of Leuven, Leuven, Belgium
- 4VU University Medical Center, Amsterdam, The Netherlands
- 5Simpson Centre for Reproductive Health, Royal Infirmary of Edinburgh, 51 Little France Crescent, Edinburgh, Scotland
- 6Hospital Universitari Sant Joan de Déu, Passeig Sant Joan de Deu, Esplugues, Barcelona
- 7Leeds General Infirmary, Great George Street, Leeds, UK
- 8Luton and Dunstable Hospital, Luton, UK
- 9Centre for Applied Medical Statistics, Department of Public Health and Primary Care, University of Cambridge Forvie Site, Institute of Public Health, Robinson Way, UK
- Correspondence to K Beardsall, Neonatal Unit, Rosie Maternity, Addenbrookes Hospital, Hills Road, Cambridge CB2 2QQ, UK;
Contributors The NIRTURE trial was devised by AOS, KB, JSA and DBD. KB, AOS, PM, SV, CV, MW, MT, LC, MT, CP, JSA, FdeZ and DBD were involved in design of the study protocol. KB, SV, CV, MW, MT, MT, IO, CT, MJ, BG and LC gathered data. KB and CP designed this validation analyses, analysed the data and vouch for the data and analysis. KB wrote the first draft of the paper and all authors contributed to the subsequent redrafts of the paper and agreed on publication.
- Received 11 January 2012
- Accepted 30 April 2012
- Published Online First 12 July 2012
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.
Funding NovoNordisk, Clinicip consortium, Medtronic, Leeds General Infirmary.
Competing interests None.
Provenance and peer review Not commissioned; externally peer reviewed.