Comparison of Accu Chek Inform II point-of-care test blood glucose meter with Hexokinase Plasma method for a diabetes mellitus population during surgery under general anesthesia

Purpose Blood glucose (BG) concentrations of patients with diabetes mellitus (DM) are monitored during surgery to prevent hypo- and hyperglycemia. Access to point-of-care test (POCT) glucose meters at an operating room will usually provide monitoring at shorter intervals and may improve glycemic control. However, these meters are not validated for patients under general anesthesia. Methods This cross-sectional study included 75 arterial BG measurements from 75 patients (71 with DM, mostly insulin dependent) who underwent elective non-cardiac surgery under general anesthesia. Arterial blood samples were taken at least 60 minutes after induction. One drop of blood was used for Accu Chek Inform II (ACI II) POCT BG meter and the residual blood was sent to the clinical laboratory for a Hexokinase Plasma reference method. A Bland-Altman plot was used to visualize the differences between both methods, and correlation was assessed using the intra-class correlation coefficient (ICC). Results The results showed an estimated mean difference of 0.8 mmol/L between ACI II and the reference method, with limits of agreement equal to -0.6 and 2.2 mmol/L. In general, the reference method produced higher values than ACI II. ICC was 0.955 (95% CI 0.634-0.986), P &lt; 0.001, and concordance correlation coefficient (CCC) was 0.955 (95% CI 0.933-0.970). Conclusion Arterial BG measurements during surgery in patients with DM under general anesthesia using POCT BG meter are in general lower than laboratory measurements, but the ICC and CCC show a clinically acceptable correlation. We conclude that POCT measurements conducted on arterial specimens using the ACI II provide sufficiently accurate results for glucose measurement during surgery under general anesthesia.</p

Performance of continuous glucose monitoring devices during intensive exercise conditions in people with diabetes:the Mont Blanc experience

With increasing use of both flash glucose monitoring and real-time continuous glucose monitoring and the reliance of users on these readings, accuracy is important, in particular during intensive exercise. We investigated the performance of the FreeStyle Libre 1 flash glucose monitor and the Guardian Connect EnliteTM real-time continuous glucose monitor by comparing readings with self-monitored blood glucose values during intensive exercise.</p

Determinants of HbA1c reduction with FreeStyle Libre flash glucose monitoring (FLARE-NL 5)

Aims: To identify factors predicting HbA1c reduction in patients with diabetes mellitus (DM) using FreeStyle Libre Flash Glucose Monitoring (FSL-FGM). Methods: Data from a 12-month prospective nation-wide FSL registry were used and analysed with multivariable regression. For the present study we included patients with hypoglycaemia unawareness or unexpected hypoglycaemias (n = 566) and persons who did not reach acceptable glycaemic control (HbA1c > 70 mmol/mol (8.5%)) (n = 294). People with other indications for use, such as sensation loss of the fingers or individuals already using FSL-FGM or rtCGM, were excluded (37%). Results: Eight hundred and sixty persons (55% male with a mean age of 46.7 (+/- 16.4) years) were included. Baseline HbA1c was 65.1 (+/- 14.5) mmol/mol (8.1 +/- 1.3%), 75% of the patients had type 1 DM and 37% had microvascular complications. Data concerning HbA1c was present for 482 (56.0%) at 6 months and 423 (49.2%) persons at 12 months. A significant reduction in HbA1c (>= 5 mmol/mol (0.5%)) was present in 187 (22%) persons. For these persons, median HbA1c reduction was -9.0 [-13.0, -4.0] mmol/mol (-0.82 [-1.19, -0.37]%) at 6 months and -9.0 [-15.0, -7.0] mmol/mol (-0.82 [-1.37, -0.64]%) at 12 months. In multi-variable regression analysis with age, gender and SF-12 physical and mental component scores as covariates, only baseline HbA1c was significant: -0.319 (SE 0.025; p <0.001; R-2 = 0.240 for the model). In exploratory analysis among subgroups with different indications for FSL-FGM use (hypoglycaemia unawareness or persistently high HbA1c) and persons with a significant HbA1c decrease over the study period, baseline HbA1c remained the only significant predictor. Conclusions: Among the variables we analysed in the present study, only high HbA1c at baseline predicts significant HbA1c reduction during FSL-CGM use

Use of FreeStyle Libre Flash Monitor Register in the Netherlands (FLARE-NL1):Patient Experiences, Satisfaction, and Cost Analysis

In patients with diabetes mellitus (DM), adequate glucose control is of major importance. When treatment schemes become more complicated, proper self-management through intermittent self-measurement of blood glucose (SMBG), among others, becomes crucial in achieving this goal. In the last decade, continuous glucose monitoring (CGM) has been on the rise, providing not only intermittent information but also information on continuous glucose trends. The FreeStyle Libre (FSL) Flash CGM system is a CGM system mainly used for patients with DM and is designed based on the same techniques as early CGMs. Compared with earlier CGMs, the FSL is factory calibrated, has no automated readings or direct alarms, and is cheaper to use. Although less accurate compared with the gold standard for SMBG, users report high satisfaction because it is easy to use and can help users monitor glucose trends. The Flash Monitor Register in the Netherlands (FLARE-NL) study aims to assess the effects of FSL Flash CGM use in daily practice. The study has a before-after design, with each participant being his or her own control. Users will be followed for at least 1 year. The endpoints include changes in HbA1c, frequency and severity of hypoglycemias, and quality of life. In addition, the effects of its use on work absenteeism rate, diabetes-related hospital admission rate, and daily functioning (including sports performance) will be studied. Furthermore, cost-benefit analysis based on the combination of registered information within the health insurance data will be investigated. Ultimately, the data gathered in this study will help increase the knowledge and skills of the use of the Flash CGM in daily practice and assess the financial impact on the use of the Flash CGM within the Dutch healthcare system

Prediction-Coherent LSTM-based Recurrent Neural Network for Safer Glucose Predictions in Diabetic People

In the context of time-series forecasting, we propose a LSTM-based recurrent neural network architecture and loss function that enhance the stability of the predictions. In particular, the loss function penalizes the model, not only on the prediction error (mean-squared error), but also on the predicted variation error. We apply this idea to the prediction of future glucose values in diabetes, which is a delicate task as unstable predictions can leave the patient in doubt and make him/her take the wrong action, threatening his/her life. The study is conducted on type 1 and type 2 diabetic people, with a focus on predictions made 30-minutes ahead of time. First, we confirm the superiority, in the context of glucose prediction, of the LSTM model by comparing it to other state-of-the-art models (Extreme Learning Machine, Gaussian Process regressor, Support Vector Regressor). Then, we show the importance of making stable predictions by smoothing the predictions made by the models, resulting in an overall improvement of the clinical acceptability of the models at the cost in a slight loss in prediction accuracy. Finally, we show that the proposed approach, outperforms all baseline results. More precisely, it trades a loss of 4.3\% in the prediction accuracy for an improvement of the clinical acceptability of 27.1\%. When compared to the moving average post-processing method, we show that the trade-off is more efficient with our approach

A retrospective in-depth analysis of continuous glucose monitoring datasets for patients with hepatic glycogen storage disease:Recommended outcome parameters for glucose management

Continuous glucose monitoring (CGM) systems have great potential for real-time assessment of glycemic variation in patients with hepatic glycogen storage disease (GSD). However, detailed descriptions and in-depth analysis of CGM data from hepatic GSD patients during interventions are scarce. This is a retrospective in-depth analysis of CGM parameters, acquired in a continuous, real-time fashion describing glucose management in 15 individual GSD patients. CGM subsets are obtained both in-hospital and at home, upon nocturnal dietary intervention (n = 1), starch loads (n = 11) and treatment of GSD Ib patients with empagliflozin (n = 3). Descriptive CGM parameters, and parameters reflecting glycemic variation and glycemic control are considered useful CGM outcome parameters. Furthermore, the combination of first and second order derivatives, cumulative sum and Fourier analysis identified both subtle and sudden changes in glucose management; hence, aiding assessment of dietary and medical interventions. CGM data interpolation for nocturnal intervals reduced confounding by physical activity and diet. Based on these analyses, we conclude that in-depth CGM analysis can be a powerful tool to assess glucose management and optimize treatment in individual hepatic GSD patients

Performance of the FreeStyle Libre Flash glucose monitoring system in patients with type 1 and 2 diabetes mellitus

OBJECTIVE: To evaluate the performance of the FreeStyle Libre Flash continuous glucose monitoring (FSL-CGM) system against established central laboratory methods. RESEARCH DESIGN AND METHODS: 20 subjects (8 type 1 diabetes mellitus, 12 type 2 diabetes mellitus) were analyzed. FSL-CGM sensor measurements (inserted in arm and abdomen) were compared with capillary blood glucose results analyzed with StatStrip as semigold standard. The glucose response after a standardized oral glucose load was measured by FSL-CGM and capillary samples analyzed by perchloric acid hexokinase (PCA-HK) method, StatStrip and FSL test strip (FSLC), and a commonly used CGM system (iPro2). RESULTS: FSL-CGM arm sensor readings showed 85.5% of paired readings falling within Clarke Error Grid (ISO 15197:2013) zone A when compared with StatStrip. For FSL-CGM abdomen and FSLC, these percentages were 64% and 98%, respectively. The overall correlation of FSL-CGM in the arm and the StatStrip indicates a performance with lower results with the FSL-CGM in the arm than expected based on the StatStrip in the lower glucose ranges, and higher results than expected in the higher ranges. Following a standardized glucose load, a slower rise in glucose level was observed for FSL-CGM arm as compared with PCA-HK, StatStrip, FSLC, and iPro2 during the first 45–60 min after glucose load ingestion. CONCLUSIONS: Certain matters need attention while using the FSL-CGM in daily life including the observed lower values in the lower ranges, and the underestimation of the effect of a meal on glucose response. These effects of such deviations can partly be overcome by optimizing the available user instructions. TRIAL REGISTRATION NUMBER: TC5348; results

A generic emergency protocol for patients with inborn errors of metabolism causing fasting intolerance:A retrospective, single-center study and the generation of www.emergencyprotocol.net

Patients with inborn errors of metabolism causing fasting intolerance can experience acute metabolic decompensations. Long‐term data on outcomes using emergency letters are lacking. This is a retrospective, observational, single‐center study of the use of emergency letters based on a generic emergency protocol in patients with hepatic glycogen storage diseases (GSD) or fatty acid oxidation disorders (FAOD). Data on hospital admissions, initial laboratory results, and serious adverse events were collected. Subsequently, the website www.emergencyprotocol.net was generated in the context of the CONNECT MetabERN eHealth project following multiple meetings, protocol revisions, and translations. Representing 470 emergency protocol years, 127 hospital admissions were documented in 54/128 (42%) patients who made use of emergency letters generated based on the generic emergency protocol. Hypoglycemia (here defined as glucose concentration 5 years. Convulsions, coma, or death was not documented. By providing basic information, emergency letters for individual patients with hepatic GSD or the main FAOD can be generated at www.emergencyprotocol.net, in nine different languages. Generic emergency protocols are safe and easy for home management by the caregivers and the first hour in‐hospital management to prevent metabolic emergencies in patients with hepatic GSD and medium‐chain Acyl CoA dehydrogenase deficiency. The website www.emergencyprotocol.net is designed to support families and healthcare providers to generate personalized emergency letters for patients with hepatic GSD and the main FAOD

A prolonged run-in period of standard subcutaneous microdialysis ameliorates quality of interstitial glucose signal in patients after major cardiac surgery

We evaluated a standard subcutaneous microdialysis technique for glucose monitoring in two critically ill patient populations and tested whether a prolonged run-in period improves the quality of the interstitial glucose signal. 20 surgical patients after major cardiac surgery (APACHE II score: 10.1 ± 3.2) and 10 medical patients with severe sepsis (APACHE II score: 31.1 ± 4.3) were included in this investigation. A microdialysis catheter was inserted in the subcutaneous adipose tissue of the abdominal region. Interstitial fluid and arterial blood were sampled in hourly intervals to analyse glucose concentrations. Subcutaneous adipose tissue glucose was prospectively calibrated to reference arterial blood either at hour 1 or at hour 6. Median absolute relative difference of glucose (MARD), calibrated at hour 6 (6.2 (2.6; 12.4) %) versus hour 1 (9.9 (4.2; 17.9) %) after catheter insertion indicated a significant improvement in signal quality in patients after major cardiac surgery (p < 0.001). Prolonged run-in period revealed no significant improvement in patients with severe sepsis, but the number of extreme deviations from the blood plasma values could be reduced. Improved concurrence of glucose readings via a 6-hour run-in period could only be achieved in patients after major cardiac surgery