Continuous Glucose Monitoring in Very Preterm Infants: A Randomized Controlled Trial (original) (raw)
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Targeting glucose control in preterm infants: pilot studies of continuous glucose monitoring
Archives of disease in childhood. Fetal and neonatal edition, 2018
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). 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. 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 (...
Archives of Disease in Childhood - Fetal and Neonatal Edition, 2018
In the very low birthweight (VLBW) infant population, high glucose concentrations have been associated with increased mortality, brain injury, retinopathy of prematurity and worse neurodevelopmental outcomes. However, trials to prevent or treat hyperglycaemia in this population with continuous insulin infusions or a combination of insulin and/or reductions in the glucose infusion rate have been complicated by more frequent episodes of low glucose concentrations. While the long-term significance of these episodes is unknown, most would agree that they should be avoided during treatment of hyperglycaemia with insulin. Emerging data further associate increased glycaemic variability with impaired long-term outcomes. Use of continuous (interstitial) glucose monitoring (CGM) in very preterm, VLBW infants has the potential to minimise the incidence and severity of hypoglycaemia and hyperglycaemia and increase glycaemic stability during critical developmental periods, providing new opportunities to improve long-term neurocognitive outcomes in these children by preventing these common but potentially harmful metabolic disorders. Thomson et al 1 report the results of a single-centre study in which feasibility of CGM for very preterm infants was assessed. The study was divided into two phases. In the first phase, accuracy was assessed by comparison of real-time (RT) CGM (Paradigm Veo, Medtronic MiniMed) to point-of-care (POC) blood glucose concentrations (Statstrip, Nova Biomedical) in 20 infants. In the second phase, a pilot study was conducted in which 20 infants were randomised to unblinded RT-CGM in conjunction with a clinical guideline dictating care decisions based on the CGM values versus standard neonatal care. In the standard care arm, infant interstitial glucose concentrations were measured with a blinded retrospective
Italian Journal of Pediatrics, 2018
Background: Continuous glucose monitoring using subcutaneous sensors is useful in the management of glucose control in neonatal intensive care. We evaluated feasibility and reliability of a continuous glucose monitoring system in a population of very low birth weight neonates needing parenteral nutrition. Moreover, we presented percentiles of glycemia of the studied population. Methods: Very low birth weight neonates were enrolled within 24 h from birth. An ENLITE sensor connected to a continuous glucose monitoring system was inserted and maintained for at least 72 h. Data obtained with the continuous glucose monitoring system and with a glucometer were compared. Calibration was performed every 12 h. Results: Twenty-three patients (9 males) were included. Median gestational age was 28 weeks (range 23-30) and median birth weight was 860 g (range 500-1092). A total of 299 paired glucose values were obtained. Modified Clarke Error Grid criteria for clinical significance were met. 74 and 33 episodes of hypoglycemia and hyperglycemia were detected, respectively. 31,329 values of glycemia were analyzed and the percentiles calculated. Conclusions: This continuous glucose monitoring system is safe and accurate. It allows increasing the detection of hypo-and hyper-glycaemia episodes and it could be routinely used in the management of glucose infusion in very low birth weight neonates under total parenteral nutrition.
PLOS ONE, 2015
Objectives Hypoglycemia is frequent in very low birth weight (VLBW) neonates and compromises their neurological outcome. The aim of this study was to compare real-time continuous glucose monitoring system (RT-CGMS) to standard methods by intermittent capillary blood glucose testing in detecting and managing hypoglycemia. Study design Forty-eight VLBW neonates were enrolled in this prospective study. During their 3 first days of life, their glucose level was monitored either by RT-CGMS (CGM-group), or by intermittent capillary glucose testing (IGM-group) associated with a blind-CGMS to detect retrospectively missed hypoglycemia. Outcomes were the number and duration of hypoglycemic (50mg/dl) episodes per patient detected by CGMS. Results Forty-three monitorings were analyzed (IGM n = 21, CGM n = 22), with a median recording time of 72 hours. In the IGM group, blind-CGMS revealed a significantly higher number of hypoglycemia episodes than capillary blood glucose testing (1.2AE0.4 vs 0.4AE0.2 episode/patient, p<0.01). In the CGM-group, the use of RT-CGMS made it possible (i) to detect the same number of hypoglycemia episodes as blind-CGMS (1.2AE0.4 episode/patient), (ii) to adapt the glucose supply in neonates with hypoglycemia (increased supply during days 1 and 2), and (iii) to significantly reduce the duration of hypoglycemia episodes per patient (CGM 44[10-140] min versus IGM 95[15-520] min, p<0.05). Furthermore, it reduced the number of blood samples (CGM 16.9AE1.0 vs IGM 21.9AE1.0 blood sample/patient, p<0.001).
Continuous glucose monitoring in preterm infants: evaluation by a modified Clarke error grid
Italian Journal of Pediatrics, 2016
Background: Continuous glucose monitoring using subcutaneous sensors has been validated in adults and children with diabetes, and was found to be useful in the management of glucose control. We aimed to assess feasibility and reliability of a new continuous glucose monitoring system (CGMS) in a population of preterm neonates using a Clarke error grid (CEG) specifically modified for preterm infants. Methods: Preterm infants were recruited within 24 h from delivery. A subcutaneous sensor connected to a CGMS was inserted and maintained for 6 days. Data collected from CGMS were compared with data obtained using a glucometer. Management of the infants followed standard protocols and was not influenced by CGMS readings. Results: Twenty patients (9 males) were included. Median (range) gestational age was 32 weeks (27-36) and median (range) birth weight was 1350 g (860-3360). Average CGMS recording time was 137 h, for a total of 449 paired glucose levels. CEG and modified CEG criteria for clinical significance were met. Conclusion: CGMS is a safe and clinically adequate method to estimate glucose levels in preterm infants. As the glucose level can be evaluated in real time, this CGMS could be useful to reduce the number of heel sticks, to observe glycaemic trends and to promptly detect episodes of both hypo-and hyper-glycaemia.
Validation of the continuous glucose monitoring sensor in preterm infants
Archives of Disease in Childhood - Fetal and Neonatal Edition, 2012
Background: In pregnant women with type 1 diabetes tight glycemic control reduces perinatal complications. Intensive observation of glucose profiles is essential in the achievement of tight glycemic control. The recent availability of the Continuous Glucose Monitoring System (CGMS ® , Minimed, Sylmar, CA) creates the opportunity to obtain more complete glucose profiles. This study was aimed at evaluating the accuracy of the CGMS in pregnant women with type 1 diabetes. Methods: Five pregnant women with type 1 diabetes were asked to use two CGMS devices simultaneously. The simultaneously measured glucose levels were analyzed using the Pearson correlation, the mean absolute difference, and Bland-Altman analysis. Second, the percentage of concordance of paired data in the hypoglycemic, normoglycemic, or hyperglycemic range was calculated. Results: The correlation coefficient between simultaneously measured data was 0.94 (P Ͻ 0.001). The mean absolute difference was 1.1 Ϯ 0.8 mmol/L. Bland-Altman analysis shows that 95% of the data pairs have a difference Յ1.74 mmol/L. Almost 80% of the data pairs could be classified in the same glucose range. In 81% of the non-concordant pairs, one glucose value was classified in the hypoglycemic range and one in the normoglycemic range. Conclusions: This study shows that the reproducibility of the CGMS in pregnant women with type 1 diabetes is adequate. This indicates that the CGMS is a useful tool in the management of type 1 diabetes in pregnant women. However, the CGMS should only be used as a supplementary method of daily glucose level measurement as a small degree of error, mainly in the hypoglycemic range, is present.
Efficacy and Mechanism Evaluation, 2021
Background Hyperglycaemia and hypoglycaemia are common in preterm infants and are associated with increased mortality and morbidity. Continuous glucose monitoring is widely used to target glucose control in adults and children, but not in neonates. Objective To evaluate the role of continuous glucose monitoring in the preterm infant. Design The REAl-time Continuous glucose moniToring in neonatal intensive care project combined (1) a feasibility study, (2) a multicentre randomised controlled trial and (3) a pilot of ‘closed-loop’ continuous glucose monitoring. The feasibility study comprised a single-centre study (n = 20). Eligibility criteria included a birthweight ≤ 1200 g and aged ≤ 48 hours. Continuous glucose monitoring was initiated to support glucose control. The efficacy and safety outcomes guided the design of the randomised controlled trial. The randomised controlled trial comprised a European multicentre trial (n = 182). Eligibility criteria included birthweight ≤ 1200 g a...
Acta paediatrica (Oslo, Norway : 1992), 2017
We evaluated a strict strategy that aimed to avoid fluctuations in glucose infusion rates (GIRs) and assessed the independent effects of maximal daily GIRs on the hyperglycaemia risk among extremely low birth weight (ELBW) infants receiving early enhanced parenteral nutrition. This study comprised all ELBW infants admitted to the neonatal intensive care unit of Oslo University Hospital Rikshospitalet, Norway before (2007-2009) and after (2012-2013) implementing a strict GIR strategy. Severe hyperglycaemia was defined as two consecutive blood glucose values over12 mmol/L. Maximum daily GIRs (mg/kg/min) were categorised into low (<5.1), intermediate (5.1-7.0) or high (>7.0). Mixed effects logistic regression modelling for repeated measurements was applied to investigate independent determinants of hyperglycaemia. We included 1,293 treatment days for 195 infants. The maximum daily GIR decreased (6.3 versus 5.8 mg/kg/min), while mean daily glucose and energy intakes were maintaine...
Incidence and Risk Factors for Glucose Disturbances in Premature Infants
Medicina
Background and Objectives: There are limited data regarding the incidence and risk factors for hypoglycemia, hyperglycemia, and unstable glycemia in preterm infants. The aim of the present study was to determine the incidence and risk factors associated with neonatal hypoglycemia, hyperglycemia, and unstable glycemia in preterm infants during the first seven days of life. Materials and Methods: This prospective study included preterm infants <37 weeks of gestation, admitted to the Neonatal Intensive Care Unit between January 2018 and December 2020. Based on blood glucose levels in the first week of life, infants were divided into the following four groups: normoglycemic, hypoglycemic, hyperglycemic, and unstable. Blood glucose levels were measured from capillary blood at the 1st, 3rd, 6th, and 12th hour of life during the first 24 h, and at least once a day from days 2 to 7, prefeed. Results: Of 445 enrolled infants, 20.7% (92/445) were categorized as hypoglycemic, 9.9% (44/445) ...