Fetal exposure to glycemic variability and hyperglycemia seems to be important in determining fetal overgrowth in pregnant women with diabetes. Optimal glucose control and less glucose variability are needed as early as possible in both type 1 diabetes and GDM patients to ensure normal fetal growth.

Background: The objective of this work was to determine the clinical accuracy of GlucoMen®Day, a new microdialysis-based continuous glucose monitoring system (CGMS) from A. Menarini Diagnostics (Florence, Italy). Accuracy evaluation was performed using continuous glucose-error grid analysis (CG-EGA), as recommended by the Performance Metrics for Continuous Interstitial Glucose Monitoring; Approved Guideline (POCT05-A). Methods: Two independent clinical trials were carried out on patients with types 1 and 2 diabetes mellitus, the glycemic levels of whom were monitored in an in-home setting for 100-hour periods. A new multiparametric algorithm was developed and used to compensate in real-time the GlucoMen®Day signal. The time lag between continuous glucose monitoring (CGM) and reference data was first estimated using the Poincaré plot method. The entire set of CGM/reference data pairs was then evaluated following the CG-EGA criteria, which allowed an estimation of the combined point and rate accuracy stratified by glycemic ranges. Results: With an estimated time lag of 11 minutes, the linear regression analysis of the CGM/reference glucose values yielded r = 0.92. The mean absolute error (MAE) was 11.4 mg/dl. The calculated mean absolute rate deviation (MARD) was 0.63 mg/dl/min. The data points falling within the A+B zones of CG-EGA were 100% in hypoglycemia, 95.7% in euglycemia, and 95.2% in hyperglycemia. Conclusions: The GlucoMen®Day system provided reliable, real-time measurement of subcutaneous glucose levels in patients with diabetes for up to 100 hours. The device showed the ability to follow rapid glycemic excursions and detect severe hypoglycemic events accurately. Its accuracy parameters fitted the criteria of the state-of-the-art consensus guideline for CGMS, with highly consistent results from two independent studies.

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BackgroundAchieving good glycemic control in intensive care units (ICU) requires a safe and efficient insulin infusion protocol (IIP). We aimed to compare the clinical performance of two IIPs (Leuven versus modified Yale protocol) in patients admitted to medical ICU, by using continuous glucose monitoring (CGM). This is a pooled data analysis of two published prospective randomized controlled trials. CGM monitoring was performed in 57 MICU patients (age 64 ± 12 years, APACHE-II score 28 ± 7, non-diabetic/diabetic: 36/21). The main outcome measures were percentage of time in normoglycemia (80–110 mg/dl) and in hypoglycemia (<60 mg/dl), and glycemic variability (standard deviation, coefficient of variation, mean amplitude of glucose excursions, mean of daily differences).ResultsTwenty-two subjects were treated using the Leuven protocol and 35 by the Yale protocol; >63,000 CGM measurements were available. The percentage of time in normoglycemia (80–110 mg/dl) was higher (37 ± 15 vs. 26 ± 11%, p = 0.001) and percentage of time spent in hypoglycemia was lower (0[0–2] vs. 5[1–8]%, p = 0.001) in the Yale group. Median glycemia did not differ between groups (118[108–128] vs. 128[106–154] mg/dl). Glycemic variability was less pronounced in the Yale group (median SD 28[21–37] vs. 47[31–71] mg/dl, p = 0.001; CV 23[19–31] vs. 36[26–50]%, p = 0.001; MODD 35[26–41] vs. 60[33–94] mg/dl, p = 0.001). However, logistic regression could not identify type of IIP, diabetes status, age, BMI, or APACHE-II score as independent parameters for strict glucose control.ConclusionsThe Yale protocol provided better average glycemia, more time spent in normoglycemia, less time in hypoglycemia, and less glycemic variability than the Leuven protocol, but was not independently associated with strict glycemic control.Electronic supplementary materialThe online version of this article (doi:10.1186/s13613-016-0214-9) contains supplementary material, which is available to authorized users.

These results provide clear insights into the advantages offered by the use of a microdialysis-based CGM system that additionally relies on the detection of hydrogen peroxide at low operating potential. GlucoMen Day may become the CGM system of choice for those patients who require either regular administration of drugs or their glycemia to be tightly controlled in the intensive care unit or similar environments.

Abbreviations: (BG) blood glucose, (CGM) continuous glucose monitoring, (GMD) GlucoMen Day, (GPB) glucose peak broadening, (IFG) interstitial fluid glucose, (ISF) interstitial fluid, (MAE) mean absolute error, (MARD) mean absolute rate deviation, (MARE) mean absolute relative error, (MedAE) median of the absolute error, (MedARD) median absolute rate deviation, (MedARE) median absolute relative error, (VB) venous blood

The relationship between both interstitial and blood glucose remains a debated topic, on which there is still no consensus. The experimental evidence suggests that blood and interstitial fluid glucose levels are correlated by a kinetic equilibrium, which as a consequence has a time and magnitude gradient in glucose concentration between blood and interstitium. Furthermore, this equilibrium can be perturbed by several physiological effects (such as foreign body response, wound-healing effect, etc.), with a consequent reduction of interstitial fluid glucose versus blood glucose correlation. In the present study, the impact of operating in the interstitium on continuous glucose monitoring systems (CGMs) will be discussed in depth, both for the application of CGMs in the management of diabetes and in other critical areas, such as tight glycaemic control in critically ill patients.

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