Journal of diabetes science and technology
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J Diabetes Sci Technol · Jul 2013
Performance evaluations of continuous glucose monitoring systems: precision absolute relative deviation is part of the assessment.
Even though a Clinical and Laboratory Standards Institute proposal exists on the design of studies and performance criteria for continuous glucose monitoring (CGM) systems, it has not yet led to a consistent evaluation of different systems, as no consensus has been reached on the reference method to evaluate them or on acceptance levels. As a consequence, performance assessment of CGM systems tends to be inconclusive, and a comparison of the outcome of different studies is difficult. ⋯ Evaluation of CGM performance studies should follow an identical study design, including sufficient swings in glycemia. At least a part of the study participants should wear two identical CGM sensors in parallel. All data available should be used for evaluation, both by MARD and PARD, a good PARD value being a precondition to trust a good MARD value. Results should be analyzed and presented separately for clinically different categories, e.g., hypoglycemia, exercise, or night and day.
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J Diabetes Sci Technol · Jul 2013
Comparative Study Clinical TrialPerformance evaluation of three continuous glucose monitoring systems: comparison of six sensors per subject in parallel.
This study is aimed at comparing the performance of three continuous glucose monitoring (CGM) systems following the Clinical and Laboratory Standards Institute's POCT05-A guideline, which provides recommendations for performance evaluation of CGM systems. ⋯ In this study, two sensors of each of the three CGM systems were compared in a setting following POCT05-A recommendations. The Navigator CGM system achieved more accurate results than the Guardian or the Seven Plus with respect to MARD and PARD. Performance in the hypoglycemic range was markedly worse for all CGM systems when compared with BG results.
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J Diabetes Sci Technol · Jul 2013
Clinical TrialPerformance evaluation of a continuous glucose monitoring system under conditions similar to daily life.
This study aimed at evaluating and comparing the performance of a new generation of continuous glucose monitoring (CGM) system versus other CGM systems, under daily lifelike conditions. ⋯ The Dexcom G4 CGM system showed good overall MARD compared with results reported for other commercially available CGM systems. In the hypoglycemic range, where CGM performance is often reported to be low, the Dexcom G4 CGM system achieved better MARD than that reported for other CGM systems in the hypoglycemic range. In the hyperglycemic range, the MARD was comparable to that reported for other CGM systems, whereas during induced glucose excursions, the MARD was similar or slightly worse than that reported for other CGM systems. Overall PARD was 7.3%, improving markedly with sensor life time.
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J Diabetes Sci Technol · Jul 2013
Perioperative management of patients with diabetes undergoing ambulatory elective surgery.
The objective was to assess processes of care for patients with diabetes undergoing elective surgery. ⋯ These data indicate suboptimal documentation of outpatient hemoglobin A1c. Intraoperative glucose monitoring seldom occurred, despite prolonged periods under anesthesia and perioperative deterioration of glycemic control. Standards need to be developed and interventions are needed to enhance management of diabetes patients undergoing elective procedures.
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J Diabetes Sci Technol · May 2013
"Turn it off!": diabetes device alarm fatigue considerations for the present and the future.
Safe and widespread use of diabetes technology is constrained by alarm fatigue: when someone receives so many alarms that he or she becomes less likely to respond appropriately. Alarm fatigue and related usability issues deserve consideration at every stage of alarm system design, especially as new technologies expand the potential number and complexity of alarms. ⋯ With examples from diabetes devices, we illustrate two complementary frameworks for alarm design: a "patient safety first" perspective and a focus on human factors. We also describe opportunities and challenges that will come with new technologies such as remote monitoring, adaptive alarms, and ever-closer integration of glucose sensing with insulin delivery.