Table 2.

List of Recommendations and Requirements for Time-Discrete Glucose Sensor Devices

Patients	1. The sensor device must be tested under real-life conditions, similar to its use in clinical practice (in order to take into account most random interferences).
	2. The sensor device must be tested in a population of the intended use (i.e., similar patient group as target patient population, e.g., diabetes of pregnancy vs TGC in critically ill patients).
	3. Sufficient number of patients and sufficient number of measurements per patient are required for statistical reasons.
Blood glucose range	4. Glucose measurements should be spread over the full glycemic range.
	5. The median and interquartile ranges of the glucose measurements must be reported to clarify the clinical context and compared with the patient's target glucose range.
Glucose sensing in the ICU	6. Sampling of arterial blood is a prerequisite when applying TGC in the ICU. In noncritically ill patient populations, the use of venous/capillary blood is accepted, assuming physiological features (e.g., lag time) typical of the sampling compartment are understood.
Evaluation methodology	7. Glucose sensor performance should be evaluated both for the full glycemic range as well as for the individual hypo/normo/hyperglycemic range.
	8. Limits of agreement (e.g., Bland-Altman analysis) should be smaller than the difference of the patient's target zone (e.g., 110 mg/dl ? 80 mg/dl = 30 mg/dl in the context of TGC in critically ill patients), preferably over the entire glycemic range, in case of nonpersistent measurement behavior for each individual hypo/normo/hyperglycemic range.
	9. Sensor accuracy should be computed with respect to clinically defined criteria, preferably statistically based (e.g., GLYCENSIT Phase 2 for the ISO criteria).
	10. Overestimation measurement behavior in the hypoglycemic range may lead to clinically wrong treatment decisions and should be avoided accordingly.