Dataset Information

The value of real-time continuous glucose monitoring in premature infants of diabetic mothers.

ABSTRACT: To determine the feasibility of using a real-time continuous glucose monitoring system (RTGMS) in intensive care units, our study focus on preterm infants with diabetic mothers owing to their high risk of blood sugar abnormalities. Thirty preterm babies (M = 15 and F = 15; ? 36 week gestation age) were studied from within 72 hours of delivery. These babies were admitted to the newborn intensive care and were further categorized into groups based on whether their mothers with or without diabetic mellitus. Blood sugar levels were monitored by both RTGMS and the traditional intermittent arterial line (A-Line) glucose method. Continuous glucose monitoring were well tolerated in 30 infants. There were good consistency between RTGMS and A-Line glucose concentration measurements. Of the preterm infants, 33.33% experienced abnormal glucose levels (hypoglycemia or hyperglycemia) between the checkpoint intervals of the intermittent A-Line blood sugar measurements. RTGM showed advantages with regards to reduced pain, greater comfort, the provision of real-time information, high sensitivity (94.59%) and specificity (97.87%) in discovering abnormalities of blood sugar, which are especially valuable for premature infants of diabetic mothers. RTGMS is comparable to A-line measurement for identifying fluctuations in blood glucose in premature infants. RTGMS detects more episodes of abnormal glucose concentration than intermittent A-line blood glucose measurement. High risk infants, especially premature infants with diabetic mothers, should receive more intensive blood sugar level checks by using continuous RTGMS.

SUBMITTER: Saw HP

PROVIDER: S-EPMC5643124 | biostudies-literature | 2017

REPOSITORIES: biostudies-literature

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The value of real-time continuous glucose monitoring in premature infants of diabetic mothers.

Saw Hean-Pat HP Yao Nai-Wei NW Chiu Cheng-Di CD Chen Jia-Yuh JY

PloS one 20171016 10

To determine the feasibility of using a real-time continuous glucose monitoring system (RTGMS) in intensive care units, our study focus on preterm infants with diabetic mothers owing to their high risk of blood sugar abnormalities. Thirty preterm babies (M = 15 and F = 15; ≤ 36 week gestation age) were studied from within 72 hours of delivery. These babies were admitted to the newborn intensive care and were further categorized into groups based on whether their mothers with or without diabetic ...[more]

PMID: 29036213

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Project description:BackgroundHyperglycaemia and hypoglycaemia are common in preterm infants and have been associated with increased risk of mortality and morbidity. Interventions to reduce risk associated with these exposures are particularly challenging due to the infrequent measurement of blood glucose concentrations, with the potential of causing more harm instead of improving outcomes for these infants. Continuous glucose monitoring (CGM) is widely used in adults and children with diabetes to improve glucose control, but has not been approved for use in neonates. The REACT trial aimed to evaluate the efficacy and safety of CGM in preterm infants requiring intensive care.MethodsThis international, open-label, randomised controlled trial was done in 13 neonatal intensive care units in the UK, Spain, and the Netherlands. Infants were included if they were within 24 h of birth, had a birthweight of 1200 g or less, had a gestational age up to 33 weeks plus 6 days, and had parental written informed consent. Infants were randomly assigned (1:1) to real-time CGM or standard care (with masked CGM for comparison) using a central web randomisation system, stratified by recruiting centre and gestational age (<26 or ≥26 weeks). The primary efficacy outcome was the proportion of time sensor glucose concentration was 2·6-10 mmol/L for the first week of life. Safety outcomes related to hypoglycaemia (glucose concentrations <2·6 mmol/L) in the first 7 days of life. All outcomes were assessed on the basis of intention to treat in the full analysis set with available data. The study is registered with the International Standard Randomised Control Trials Registry, ISRCTN12793535.FindingsBetween July 4, 2016, and Jan 27, 2019, 182 infants were enrolled, 180 of whom were randomly assigned (85 to real-time CGM, 95 to standard care). 70 infants in the real-time CGM intervention group and 85 in the standard care group had CGM data and were included in the primary analysis. Compared with infants in the standard care group, infants managed using CGM had more time in the 2·6-10 mmol/L glucose concentration target range (mean proportion of time 84% [SD 22] vs 94% [11]; adjusted mean difference 8·9% [95% CI 3·4-14·4]), equivalent to 13 h (95% CI 5-21). More infants in the standard care group were exposed to at least one episode of sensor glucose concentration of less than 2·6 mmol/L for more than 1 h than those in the intervention group (13 [15%] of 85 vs four [6%] of 70). There were no serious adverse events related to the use of the device or episodes of infection.InterpretationReal-time CGM can reduce exposure to prolonged or severe hyperglycaemia and hypoglycaemia. Further studies using CGM are required to determine optimal glucose targets, strategies to obtain them, and the potential effect on long-term health outcomes.FundingNational Institute for Health Research Efficacy and Mechanisms Evaluation Programme.

Project description:Methods from non-linear dynamics have enhanced understanding of functional dysregulation in various diseases but received less attention in diabetes. This retrospective cross-sectional study evaluates and compares relationships between indices of non-linear dynamics and traditional glycemic variability, and their potential application in diabetes control. Continuous glucose monitoring provided data for 177 subjects with type 1 (n = 22), type 2 diabetes (n = 143), and 12 non-diabetic subjects. Each time series comprised 576 glucose values. We calculated Poincaré plot measures (SD1, SD2), shape (SFE) and area of the fitting ellipse (AFE), multiscale entropy (MSE) index, and detrended fluctuation exponents (?1, ?2). The glycemic variability metrics were the coefficient of variation (%CV) and standard deviation. Time of glucose readings in the target range (TIR) defined the quality of glycemic control. The Poincaré plot indices and ? exponents were higher (p < 0.05) in type 1 than in the type 2 diabetes; SD1 (mmol/l): 1.64 ± 0.39 vs. 0.94 ± 0.35, SD2 (mmol/l): 4.06 ± 0.99 vs. 2.12 ± 1.04, AFE (mmol2/l2): 21.71 ± 9.82 vs. 7.25 ± 5.92, and ?1: 1.94 ± 0.12 vs. 1.75 ± 0.12, ?2: 1.38 ± 0.11 vs. 1.30 ± 0.15. The MSE index decreased consistently from the non-diabetic to the type 1 diabetic group (5.31 ± 1.10 vs. 3.29 ± 0.83, p < 0.001); higher indices correlated with lower %CV values (r = -0.313, p < 0.001). In a subgroup of type 1 diabetes patients, insulin pump therapy significantly decreased SD1 (-0.85 mmol/l), SD2 (-1.90 mmol/l), and AFE (-16.59 mmol2/l2), concomitantly with %CV (-15.60). The MSE index declined from 3.09 ± 0.94 to 1.93 ± 0.40 (p = 0.001), whereas the exponents ?1 and ?2 did not. On multivariate regression analyses, SD1, SD2, SFE, and AFE emerged as dominant predictors of TIR (? = -0.78, -1.00, -0.29, and -0.58) but %CV as a minor one, though ?1 and MSE failed. In the regression models, including SFE, AFE, and ?2 (? = -0.32), %CV was not a significant predictor. Poincaré plot descriptors provide additional information to conventional variability metrics and may complement assessment of glycemia, but complexity measures produce mixed results.

Project description:IntroductionHyperglycaemia is common in the very preterm infant and has been associated with adverse outcomes. Preventing hyperglycaemia without increasing the risk of hypoglycaemia has proved challenging. The development of real-time continuous glucose monitors (CGM) to inform treatment decisions provides an opportunity to reduce this risk. This study aims to assess the feasibility of CGM combined with a specifically designed paper guideline to target glucose control in the preterm infant.Methods and analysesThe Real Time Continuous Glucose Monitoring in Neonatal Intensive Care (REACT) trial is an international multicentre randomised controlled trial. 200 preterm infants ≤1200 g and ≤24 hours of age will be randomly allocated to either real-time CGM or standard care (with blinded CGM data collection). The primary outcome is time in target 2.6-10 mmol/L during the study intervention assessed using CGM. Secondary outcomes include efficacy relating to glucose control, utility including staff acceptability, safety outcomes relating to incidence and prevalence of hypoglycaemia and health economic analyses.Ethics and disseminationThe REACT trial has been approved by the National Health Service Health Research Authority National Research Ethics Service Committee East of England (Cambridge Central); Medical Ethics Review Committee, VU University Medical Centre, Amsterdam, The Netherlands and the Research Ethics Committee, Sant Joan de Déu Research Foundation, Barcelona, Spain. Recruitment began in July 2016 and will continue until mid-2018. The trial has been adopted by the National Institute of Health Research Clinical Research Network portfolio (ID: 18826) and is registered with anInternational Standard Randomised Control Number (ISRCTN registry ID: 12793535). Dissemination plans include presentations at scientific conferences, scientific publications and efforts at stakeholder engagement.Trial registration numberISRCTN12793535; Pre-results.

Dataset Information

The value of real-time continuous glucose monitoring in premature infants of diabetic mothers.

Publications

The value of real-time continuous glucose monitoring in premature infants of diabetic mothers.

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