Feasibility of automated insulin delivery guided by continuous glucose monitoring in preterm infants

Abstract

ObjectiveClosed-loop systems have been used to optimise insulin delivery in children with diabetes, but they have not been tested in neonatal intensive care. Extremely preterm infants are prone to hyperglycaemia and hypoglycaemia; both of which have been associated with adverse outcomes. Insulin sensitivity is notoriously variable in these babies and glucose control is time-consuming, with management requiring frequent changes of dextrose-containing fluids and careful monitoring of insulin treatment. We aimed to evaluate the feasibility of closed-loop management of glucose control in these infants.Design and settingSingle-centre feasibility study with a randomised parallel design in a neonatal intensive care unit. Eligibility criteria included birth weight <1200 g and <48 hours of age. All infants had subcutaneous continuous glucose monitoring for the first week of life, with those in the intervention group receiving closed-loop insulin delivery in a prespecified window, between 48 and 72 hours of age during which time the primary outcome was percentage of time in target (sensor glucose 4–8 mmol/L).ResultsThe mean (SD) gestational age and birth weight of intervention and control study arms were 27.0 (2.4) weeks, 962 (164) g and 27.5 (2.8) weeks, 823 (282) g, respectively, and were not significantly different. The time in target was dramatically increased from median (IQR) 26% (6-64) with paper guidance to 91% (78-99) during closed loop (p<0.001). There were no serious adverse events and no difference in total insulin infused.ConclusionsClosed-loop glucose control based on subcutaneous glucose measurements appears feasible as a potential method of optimising glucose control in extremely preterm infants.

Open-Source Technology for Real-Time Continuous Glucose Monitoring in the Neonatal Intensive Care Unit: Case Study in a Neonate With Transient Congenital Hyperinsulinism

“…While off-label use of medication is both common practice and a necessity in newborn infants, there are few examples of off-label uses of medical devices, rtCGM being a notable exception [ 7 , 8 , 19 - 24 ]. CBG tests are the current standard of care in the management of neonatal hypoglycemia.…”

“…Evidence on rtCGM use for glycemic management in neonates is limited, and there is no evidence of calibration-free rtCGM systems in infants so far. Benefits with respect to glycemic control [ 7 ] and less procedural pain [ 8 ] have been previously described for very low-birth-weight preterm infants in a feasibility study. Furthermore, a study found continuous tissue glucose monitoring to be helpful to identify infants at risk for metabolic instabilities [ 9 ].…”

Remote Glucose Monitoring Platform for Multiple Simultaneous Patients at Coronavirus Disease 2019 Intensive Care Units: Case Report Including Adults and Children

“…Finally, remote monitoring with Dexcom G6 was evaluated using Dexcom Follow app in Reutrakul et al 4 for noncritical patients with coronavirus disease 2019 (COVID-19). Other relevant telemetry studies worth to mention that controlled multiple patients without COVID-19 are Beardsall et al 5 and Singh et al 6 This letter illustrates the potential of a new platform for simultaneous remote monitoring of multiple intensive care unit (ICU) and/or quarantined patients. To our best knowledge, this is the first multicenter, multisensor, multipatient, and potentially multitherapy platform for remote glucose monitoring employed in critically ill COVID patients.…”

“…4 Hospital Italiano de Buenos Aires, Buenos Aires, Argentina. 5 Hospital de Pediatría J. P. Garrahan, Buenos Aires, Argentina. Garrahan.…”

Real-time continuous glucose monitoring in preterm infants (REACT): an international, open-label, randomised controlled trial

“…The development of real-time CGM, which provides continuous glucose data and identifies early trends in glucose concentrations can inform clinical decisions, and has been successfully used in adult 11 and paediatric intensive care. 12 , 13 , 14 Preliminary data suggest it is feasible in preterm infants 10 , 15 , 16 , 17 and could allow earlier detection and potentially prevention of exposure to extreme glucose concentrations. 17 , 18 We aimed to formally evaluate the use of real-time CGM to guide the clinical management of glycaemic control and use of insulin in preterm infants.…”