scholarly journals Continuous glucose monitoring in extremely preterm infants in intensive care: the REACT RCT and pilot study of ‘closed-loop’ technology

2021 ◽  
Vol 8 (16) ◽  
pp. 1-142
Author(s):  
Kathryn Beardsall ◽  
Lynn Thomson ◽  
Catherine Guy ◽  
Simon Bond ◽  
Annabel Allison ◽  
...  
Keyword(s):  
Glucose Level ◽  
Continuous Glucose Monitoring ◽  
Glucose Control ◽  
Closed Loop ◽  
Controlled Trial ◽  
Glucose Monitoring ◽  
Target Range ◽  
Eligibility Criteria ◽  
Glucose Levels ◽  
Sensor Glucose

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 and aged ≤ 24 hours. Exclusion criteria included any lethal congenital abnormality. Continuous glucose monitoring was initiated to support glucose control within 24 hours of birth. In the intervention group, the continuous glucose monitoring sensor provided real-time data on glucose levels, which guided clinical management. In control infants, the continuous glucose monitoring data were masked, and glucose level was managed in accordance with standard clinical practice and based on the blood glucose levels. The primary outcome measure was the percentage of time during which the sensor glucose level was within the target range of 2.6–10 mmol/l. Secondary outcome measures included mean sensor glucose level, the percentage of time during which the sensor glucose level was within the target range of 4–8 mmol/l, the percentage of time during which the sensor glucose level was in the hyperglycaemic range (i.e. > 15 mmol/l) and sensor glucose level variability. Safety outcomes included hypoglycaemia exposure. Acceptability assessment and health economic analyses were carried out and further exploratory health outcomes were explored. The mean percentage of time in glucose target range of 2.6–10 mmol/l was 9% higher in infants in the continuous glucose monitoring group (95% confidence interval 3% to 14%; p = 0.002), and the mean time in the target range of 4–8 mmol/l was 12% higher in this group (95% confidence interval 4% to 19%; p = 0.004). There was no difference in the number of episodes of hypoglycaemia. Exploratory outcomes showed a reduced risk of necrotising enterocolitis in the intervention arm (odds ratio 0.33, 95% confidence interval 0.13 to 0.78; p = 0.01). Health economic analyses demonstrated that continuous glucose monitoring was cost-effective on the basis of the cost per additional case of adequate glucose control between 2.6 and 10 mmol/l. The ‘closed-loop’ study was a single-center pilot study, with eligibility criteria including a birthweight of ≤ 1200 g and aged ≤ 48 hours. Infants underwent continuous glucose monitoring for the first week of life (n = 21), with those in the intervention group receiving closed-loop insulin delivery between 48 and 72 hours of age. The primary outcome of percentage of time in the target range (i.e. sensor glucose 4–8 mmol/l) increased from a median of 26% (interquartile range 6–64%) to 91% (interquartile range 78–99%) during closed-loop insulin delivery (p < 0.001). Limitations These studies have not defined the optimal targets for glucose control or the best strategies to achieve them in these infants. Future work Studies are needed to evaluate the longer-term impact of targeting glucose control on clinical outcomes. Conclusions Continuous glucose monitoring in extremely preterm infants can improve glucose control, with closed-loop insulin delivery having further potential to target glucose levels. Staff and parents felt that the use of continuous glucose monitoring improved care and the results of the health economic evaluation favours the use of continuous glucose monitoring. Trial registration Current Controlled Trials ISRCTN12793535. Funding This project was funded by the Efficacy and Mechanism Evaluation (EME) programme, a MRC and National Institute for Health Research (NIHR) partnership. This will be published in full in Efficacy and Mechanism Evaluation; Vol. 8, No. 16. See the NIHR Journals Library website for further project information. Medtronic plc provided some MiniMed™ 640G systems and Nova Biomedical (Waltham, MA, USA) provided point-of-care devices.

scholarly journals Continuous Glucose Monitoring Profiles in Healthy Nondiabetic Participants: A Multicenter Prospective Study

2019 ◽  
Vol 104 (10) ◽  
pp. 4356-4364 ◽  
Author(s):  
Viral N Shah ◽  
Stephanie N DuBose ◽  
Zoey Li ◽  
Roy W Beck ◽  
Anne L Peters ◽  
...  
Keyword(s):  
Prospective Study ◽  
Median Time ◽  
Continuous Glucose Monitoring ◽  
Age Groups ◽  
Glucose Monitoring ◽  
Future Research ◽  
Glucose Levels ◽  
Sensor Glucose ◽  
Multicenter Prospective Study ◽  
Average Glucose

Abstract Context Use of continuous glucose monitoring (CGM) is increasing for insulin-requiring patients with diabetes. Although data on glycemic profiles of healthy, nondiabetic individuals exist for older sensors, assessment of glycemic metrics with new-generation CGM devices is lacking. Objective To establish reference sensor glucose ranges in healthy, nondiabetic individuals across different age groups using a current generation CGM sensor. Design Multicenter, prospective study. Setting Twelve centers within the T1D Exchange Clinic Network. Patients or Participants Nonpregnant, healthy, nondiabetic children and adults (age ≥6 years) with nonobese body mass index. Intervention Each participant wore a blinded Dexcom G6 CGM, with once-daily calibration, for up to 10 days. Main Outcome Measures CGM metrics of mean glucose, hyperglycemia, hypoglycemia, and glycemic variability. Results A total of 153 participants (age 7 to 80 years) were included in the analyses. Mean average glucose was 98 to 99 mg/dL (5.4 to 5.5 mmol/L) for all age groups except those over 60 years, in whom mean average glucose was 104 mg/dL (5.8 mmol/L). The median time between 70 to 140 mg/dL (3.9 to 7.8 mmol/L) was 96% (interquartile range, 93 to 98). Mean within-individual coefficient of variation was 17 ± 3%. Median time spent with glucose levels &gt;140 mg/dL was 2.1% (30 min/d), and median time spent with glucose levels &lt;70 mg/dL (3.9 mmol/L) was 1.1% (15 min/d). Conclusion By assessing across age groups in a healthy, nondiabetic population, normative sensor glucose data have been derived and will be useful as a benchmark for future research studies.

scholarly journals Glucose Control in the Intensive Care Unit by Use of Continuous Glucose Monitoring: What Level of Measurement Error Is Acceptable?

2014 ◽  
Vol 60 (12) ◽  
pp. 1500-1509 ◽  
Author(s):  
Malgorzata E Wilinska ◽  
Roman Hovorka
Keyword(s):  
Intensive Care Unit ◽  
Intensive Care ◽  
Measurement Error ◽  
Continuous Glucose Monitoring ◽  
Glucose Control ◽  
Glucose Monitoring ◽  
Glucose Variability ◽  
Glucose Measurement ◽  
Target Range ◽  
Mean Glucose

Abstract BACKGROUND Accuracy and frequency of glucose measurement is essential to achieve safe and efficacious glucose control in the intensive care unit. Emerging continuous glucose monitors provide frequent measurements, trending information, and alarms. The objective of this study was to establish the level of accuracy of continuous glucose monitoring (CGM) associated with safe and efficacious glucose control in the intensive care unit. METHODS We evaluated 3 established glucose control protocols [Yale, University of Washington, and Normoglycemia in Intensive Care Evaluation and Surviving Using Glucose Algorithm Regulation (NICE-SUGAR)] by use of computer simulations. Insulin delivery was informed by intermittent blood glucose (BG) measurements or CGM levels with an increasing level of measurement error. Measures of glucose control included mean glucose, glucose variability, proportion of time glucose was in target range, and hypoglycemia episodes. RESULTS Apart from the Washington protocol, CGM with mean absolute relative deviation (MARD) ≤15% resulted in similar mean glucose as with the use of intermittent BG measurements. Glucose variability was also similar between CGM and BG-informed protocols. Frequency and duration of hypoglycemia were not worse by use of CGM with MARD ≤10%. Measures of glucose control varied more between protocols than at different levels of the CGM error. CONCLUSIONS The efficacy of CGM-informed and BG-informed commonly used glucose protocols is similar, but the risk of hypoglycemia may be reduced by use of CGM with MARD ≤10%. Protocol choice has greater influence on glucose control measures than the glucose measurement method.

scholarly journals Medical Food Assessment Using a Smartphone App With Continuous Glucose Monitoring Sensors: Proof-of-Concept Study (Preprint)

2020 ◽  
Author(s):  
Hector Roux de Bézieux ◽  
James Bullard ◽  
Orville Kolterman ◽  
Michael Souza ◽  
Fanny Perraudeau
Keyword(s):  
Continuous Glucose Monitoring ◽  
Glucose Control ◽  
Glucose Monitoring ◽  
Smartphone App ◽  
Proof Of Concept ◽  
Medical Food ◽  
Concept Study ◽  
Glucose Levels ◽  
The Impact ◽  
Clinic Visits

BACKGROUND Novel wearable biosensors, ubiquitous smartphone ownership, and telemedicine are converging to enable new paradigms of clinical research. A new generation of continuous glucose monitoring (CGM) devices provides access to clinical-grade measurement of interstitial glucose levels. Adoption of these sensors has become widespread for the management of type 1 diabetes and is accelerating in type 2 diabetes. In parallel, individuals are adopting health-related smartphone-based apps to monitor and manage care. OBJECTIVE We conducted a proof-of-concept study to investigate the potential of collecting robust, annotated, real-time clinical study measures of glucose levels without clinic visits. METHODS Self-administered meal-tolerance tests were conducted to assess the impact of a proprietary synbiotic medical food on glucose control in a 6-week, double-blind, placebo-controlled, 2×2 cross-over pilot study (n=6). The primary endpoint was incremental glucose measured using Abbott Freestyle Libre CGM devices associated with a smartphone app that provided a visual diet log. RESULTS All subjects completed the study and mastered CGM device usage. Over 40 days, 3000 data points on average per subject were collected across three sensors. No adverse events were recorded, and subjects reported general satisfaction with sensor management, the study product, and the smartphone app, with an average self-reported satisfaction score of 8.25/10. Despite a lack of sufficient power to achieve statistical significance, we demonstrated that we can detect meaningful changes in the postprandial glucose response in real-world settings, pointing to the merits of larger studies in the future. CONCLUSIONS We have shown that CGM devices can provide a comprehensive picture of glucose control without clinic visits. CGM device usage in conjunction with our custom smartphone app can lower the participation burden for subjects while reducing study costs, and allows for robust integration of multiple valuable data types with glucose levels remotely. CLINICALTRIAL ClinicalTrials.gov NCT04424888; http://clinicaltrials.gov/ct2/show/NCT04424888.

scholarly journals Continuous Glucose Monitoring in the Management of Neonates with Persistent Hypoglycaemia and Congenital Hyperinsulinism

2021 ◽  
Author(s):  
Myat Win ◽  
Rowan Beckett ◽  
Lynn Thomson ◽  
Ajay Thankamony ◽  
Kathy Beardsall
Keyword(s):  
Real Time ◽  
Preterm Infants ◽  
Continuous Glucose Monitoring ◽  
Clinical Care ◽  
Neurodevelopmental Outcome ◽  
Glucose Monitoring ◽  
Relative Difference ◽  
Congenital Hyperinsulinism ◽  
Glucose Levels ◽  
Sensor Glucose

Abstract Background Persistent hypoglycaemia is common in the newborn and is associated with poor neurodevelopmental outcome. Adequate monitoring is critical in prevention, but is dependent on frequent, often hourly blood sampling. Continuous glucose monitoring (CGM) is increasingly being used in children with type 1 diabetes mellitus, but use in neonatology remains limited. We aimed to introduce real-time CGM to provide insights into patterns of dysglycaemia and to support the management of persistent neonatal hypoglycaemia. Methods This is a single centre retrospective study of real-time CGM use over a 4-year period in babies with persistent hypoglycaemia. Results CGMs were inserted in 14 babies: 8 term and 6 preterm infants, 9 with evidence of congenital hyperinsulinism (CHI). A total of 224 days of data were collected demonstrating marked fluctuations in glucose levels in babies with CHI, with a higher sensor glucose SD (1.52±0.79 mmol/l vs 0.77±0.22mmol/l) in infants with CHI compared to preterm infants. A total of 1254 paired glucose values (CGM and blood) were compared and gave a mean absolute relative difference (MARD) of 11%. Conclusion CGM highlighted the challenges of preventing hypoglycaemia in these babies when using intermittent blood glucose levels alone, and the potential application of CGM as an adjunct to clinical care.

scholarly journals Differences in glucose level between right arm and left arm using continuous glucose monitors

2020 ◽  
Vol 6 ◽  
pp. 205520762097034
Author(s):  
Nicole Kim ◽  
Kevin Pham ◽  
Allen Shek ◽  
Jeremy Lim ◽  
Xiaohan Liu ◽  
...  
Keyword(s):  
Glucose Level ◽  
Skin Irritation ◽  
Glucose Monitoring ◽  
Target Range ◽  
Glucose Levels ◽  
Significant Difference ◽  
Freestyle Libre ◽  
The Right ◽  
Mean Glucose ◽  
Time In Target Range

Background Continuous glucose monitoring (CGM) measures interstitial glucose levels through a sensor with a thin filament inserted under the skin. It is customary for patients to rotate sensor application sites between arms to minimize skin irritation. However, there is limited data regarding the degree of inter-arm differences with CGM technology. Methods Self-proclaimed right-handed (n = 5) and left-handed (n = 5) participants, regardless of concurrent comorbidities, were enrolled for CGM. Participants wore a FreeStyle Libre Pro sensor on each arm for a maximum of 14 days. Muscle mass and body fat analysis was conducted using a multi-frequency segmental body composition analyzer. Glucose levels from both arms were time-matched with the first 12 hours eliminated from analysis. Mean glucose and time in target range were compared between readings from the right and left arm. Results A total of 9830 paired glucose levels were included for analysis. In all participants (n = 10), mean glucose on the right arm was 89.1 mg/dL (SD, 19.9) and 85.3 mg/dL (SD, 19.3) on the left arm (P < 0.001). Glucose was out of target range (70-180 mg/dL) for 12.7% of the time in the right arm compared to 18.5% in the left arm (P < 0.001). Conclusions In a group of 10 nondiabetic and diabetic adults, there was a statistically significant difference in CGM readings between the right and left arms. Time in target range may differ based on arm selection when using a CGM. Arm dominance did not explain the inter-arm glucose level discordance.

The Accuracy of Hemoglobin A1c and Fructosamine Evaluated by Long-Term Continuous Glucose Monitoring in Patients with Type 2 Diabetes Undergoing Hemodialysis

2021 ◽  
pp. 1-9
Author(s):  
Tobias Bomholt ◽  
Marianne Rix ◽  
Thomas Almdal ◽  
Filip K. Knop ◽  
Susanne Rosthøj ◽  
...  
Keyword(s):  
Type 2 Diabetes ◽  
Glycemic Control ◽  
Continuous Glucose Monitoring ◽  
Plasma Glucose ◽  
Hemoglobin A1c ◽  
Glucose Monitoring ◽  
Control Group ◽  
Glucose Levels ◽  
Sensor Glucose

<b><i>Introduction:</i></b> The accuracy of hemoglobin A1c (HbA1c) as a glycemic marker in patients with type 2 diabetes (T2D) receiving hemodialysis (HD) remains unknown. To assess accuracy, we compared HbA1c and fructosamine levels with interstitial glucose measured by continuous glucose monitoring (CGM) in patients with T2D receiving HD. <b><i>Methods:</i></b> Thirty patients in the HD group and 36 patients in the control group (T2D and an estimated glomerular filtration rate &#x3e;60 mL/min/1.73 m<sup>2</sup>) completed the study period of 17 weeks. CGM (Ipro2<sup>®</sup>, Medtronic) was performed 5 times for periods of up to 7 days (with 4-week intervals) during a 16-week period. HbA1c (mmol/mol), the estimated mean plasma glucose from HbA1c (eMPGA1c [mmol/L]) and fructosamine (μmol/L) was measured at week 17 and compared with mean sensor glucose levels from CGM. <b><i>Findings:</i></b> In the HD group, mean sensor glucose was 1.4 mmol/L (95% confidence interval [CI]: 1.0–1.8) higher than the eMPGA1c, whereas the difference for controls was 0.1 mmol/L (95% CI: −0.1–[0.4]; <i>p</i> &#x3c; 0.001). Adjusted for mean sensor glucose, HbA1c was lower in the HD group (−7.3 mmol/mol, 95% CI: −10.0–[−4.7]) than in the control group (<i>p</i> &#x3c; 0.001), with no difference detected for fructosamine (<i>p</i> = 0.64). <b><i>Discussion:</i></b> HbA1c evaluated by CGM underestimates plasma glucose levels in patients receiving HD. The underestimation represents a clinical challenge in optimizing glycemic control in the HD population. Fructosamine is unaffected by the factors affecting HbA1c and appears to be more accurate for glycemic monitoring. CGM or fructosamine could thus complement HbA1c in obtaining more accurate glycemic control in this patient group.

scholarly journals Outcome of Patients with ST-T Changes in Non STSegment Elevation Myocardial Infarction

2021 ◽  
Vol 1 (1) ◽  
Author(s):  
Mohammad Arifur Rahman
Keyword(s):  
Myocardial Infarction ◽  
Continuous Glucose Monitoring ◽  
Hemoglobin A1c ◽  
Glycated Hemoglobin ◽  
Glucose Monitoring ◽  
Measurement Methods ◽  
Glucose Levels ◽  
Sensor Device ◽  
Sensor Glucose ◽  
Average Glucose

This article discusses the fundamental characteristics of measured glucose levels and predicted glycated hemoglobin A1c (HbA1c) values among three sets of collected data, measured finger-piercing and continuous glucose monitoring (CGM) sensor device collected glucose levels at 15-minute (15-min) and 5-minute (5-min) intervals. The average glucose (in milligram per deciliter-mg/dL) is listed below: Finger glucose: 109 mg/dL (100%) Sensor at 15-min: 120 mg/dL (109%) Sensor at 5-min: 117 mg/dL (107%) Using candlestick chart, the comparison of average glucoses during this period between two sensor glucose (mg/dL) data (15-min/5-min) are as follows: Open glucose: 108/111 Close glucose: 115/115 Maximum (max) glucose: 170 /175 Minimum (min) glucose: 85/83 Average glucose: 120/117 Additional analysis of time above range (TAR)≥140 mg/dL for hyperglycemia, time within the range (TIR) from 70-140 mg/dL for normal, time below range (TBR)≤70 mg/dL for hypoglycemia based on two sensor candlesticks revealing the following information in a specific format of TAR%/ TIR%/TBR%. 15-min:18.3%, 80.5%, 1.2% 5-min: 17.0%, 81.9%, 1.1% By evaluating the results of the TIR analysis, the 5-min glucose levels appear to be marginally healthier (1.4%) than the 15-min ones. During the coronavirus pandemic (COVID 19) quarantine period, the author lived a rather unique lifestyle which is extremely calm with regular routines, such as eating home-cooked meals and exercising on a regular basis. As a result, his HbA1c has decreased from 6.6% to 6.3% with an average A1c of 6.4% without taking any diabetes medications. However, these three different measurement methods still provide three different sets of glucoses levels which are within a 10% margin of differences, while the HbA1c values are particularly close to each other between the finger-piercing and CGM 15-min.

The utility of continuous glucose monitoring systems in the management of children with persistent hypoglycaemia

2021 ◽  
Vol 0 (0) ◽  
Author(s):  
Sathyakala Vijayanand ◽  
Paul G. Stevenson ◽  
Maree Grant ◽  
Catherine S. Choong ◽  
Elizabeth A. Davis ◽  
...  
Keyword(s):  
Continuous Glucose Monitoring ◽  
Glucose Monitoring ◽  
Congenital Hyperinsulinism ◽  
Glucose Levels ◽  
Parent Experience ◽  
Lower Glucose ◽  
Sensor Glucose ◽  
The Mean ◽  
Improved Accuracy

Abstract Objectives Glucose monitoring is vital in children with persistent hypoglycaemia to reduce the risk of adverse neuro-behavioural outcomes; especially in children with hyperinsulinism. The role of continuous glucose monitoring (CGM) systems in monitoring glucose levels in this cohort is limited. The objective of this study was to ascertain the effectiveness of CGM and to evaluate parents’ experience of using CGM for monitoring glucose levels in children with hypoglycaemia. Methods Retrospective analysis of sensor glucose (SG) values from Dexcom G4 CGM with paired finger-prick blood glucose (BG) values was performed to determine the accuracy of CGM. The parent experience of CGM was assessed using a questionnaire administered to families of children with congenital hyperinsulinism currently attending the clinic. Results SG data from 40 children (median age 6 months) with persistent hypoglycaemia (60% Hyperinsulinism) were analysed. The mean difference between 5,650 paired BG and SG values was 0.28 mmol/L. The sensitivity and specificity of CGM to identify severe hypoglycaemia (BG < 3.0 mmol/L) were 54.3% (95% CI: 39.0%, 69.1%) and 97.4% (95% CI: 96.9%, 97.8%) respectively. Parents (n=11) reported less anxiety (n=9), better sleep at night (n=7) and preferred to use CGM for monitoring (n=9). Conclusions Although the high number of false-positive readings precludes the routine use of CGM in the evaluation of hypoglycaemia, it avoids unnecessary BG testing during normoglycaemia. It is an acceptable tool for parents for monitoring their children who are at risk of hypoglycaemia. Newer CGM systems with improved accuracy at lower glucose levels have the potential to further improve monitoring.

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