Objective Hyperglycaemia is common in very preterm infants and is associated with adverse outcomes. Preventing hyperglycaemia without increasing the risk of hypoglycaemia is difficult. Real time tracking with continuous glucose monitors (CGM) may improve glucose control. We assessed the feasibility and safety of CGM to target glucose control in preterm infants, to inform a randomised controlled trial (RCT).
Design We performed a single centre study in very preterm infants during the first week of life. Accuracy was assessed by comparison of CGM with blood glucose levels (n=20 infants). In a separate pilot study of efficacy (n=20), real-time CGM combined with a paper guideline to target glucose control (2.6–10 mmol/L) was compared with standard neonatal care (masked CGM). Questionnaires were used to assess staff acceptability.
Results No concerns were raised about infection or skin integrity at sensor site. The sensor performed well compared with point-of-care blood glucose measurements, mean bias of −0.27 (95% CI −0.35 to −0.19). Per cent time in target range (sensor glucose 2.6–10 mmol/L) was greater with CGM than POC (77% vs 59%, respectively) and per cent time sensor glucose >10 mmol/L was less with CGM than POC (24% vs 40%, respectively). The CGM also detected clinically unsuspected episodes of hypoglycaemia. Staff reported that the use of the CGM positively improved clinical care.
Conclusions This study suggests that CGM has sufficient accuracy and utility in preterm infants to warrant formal testing in a RCT.
- continuous glucose monitoring
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Contributors The study was conceptualised by KB and DBD with input from LT. LT and KB undertook the clinical studies. DE and JH undertook the statistical analyses and produced the figures with support from SB. KB is the lead doctor for the trial and prepared the first version and subsequent revisions of the manuscript. All authors contributed to the manuscript and have approved the final manuscript prior to submission.
Funding Funding was provided by the Efficacy and Mechanism Evaluation (EME) Programme, an MRC and NIHR partnership and the Evelyn Trust, Cambridge. Medtronic provided the CGM system and sensors, and support was received from the NIHR Cambridge Biomedical Research Centre. Medtronic had no role in design of the study, the gathering of data, access to data, preparation of the manuscript or decision to publish the results. The study was jointly sponsored by the University of Cambridge and Cambridge University Hospitals NHS Foundation Trust.
Competing interests None declared.
Patient consent Parental/guardian consent obtained.
Ethics approval Cambridge Central Ethics Board.
Provenance and peer review Not commissioned; externally peer reviewed.
Data sharing statement Requests for data sharing should be made to the corresponding author.
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