In such a situation, noted the department, the glucose meter defaults to a high-complexity categorization under the terms of the Clinical Laboratory Improvement Amendments of 1988 (CLIA). The intended use statements found in the package inserts or manuals of many such products do not include the monitoring of glycemic control for non-diabetic patients in hospitals, or use on critically ill patients.Īs clarified in a frequently asked questions document issued on February 18, the purpose of the Department of Health’s letter was to “inform facilities on the policies and requirements surrounding off-label use of these devices.” Specifically, laboratories that use glucose meters for purposes or populations beyond the approved intended use are considered to be engaging in off-label use. In the past, however, manufacturers’ validation data has not been sufficient for FDA to extend this approved intended use to other patient populations or settings. The department’s letter followed by just a few days the issuance of two FDA guidance documents in which the agency established new premarket submission requirements for blood glucose monitors.įDA has long approved glucose meters for the measurement of whole blood glucose, and for use by healthcare professionals as an aid in monitoring the effectiveness of a diabetes control program. PMID: 33915605.On January 13, 2014, the New York State Department of Health sent to its licensed New York laboratories a “Dear Laboratory Director” letter regarding off-label use of glucose meters. Comparative study of i-SENS glucometers in neonates using capillary blood samples. The publication evaluates the performance of the Roche Accu-Chek Inform II, though not in a formal validation. Large-scale performance evaluation of Accu-Chek inform II point-of-care glucose meters. Jeong TD, Cho EJ, Ko DH, Lee W, Chun S, Hong KS, Min WK. The publication is a letter or correspondence in which the Roche Accu-Chek Inform II is referenced. Analysis: New point-of-care blood glucose monitoring system for the hospital demonstrates satisfactory analytical accuracy using blood from critically ill patients-an important step toward improved blood glucose control in the hospital. PMID: 33837390.įDA:2020P - Pass Neonates (0-28 days), arterial samples (n=100)įDA:2020P - Pass Neonates (0-28 days), heel-stick samples (n=100)įDA:2020P - Pass Infants to Adults (29 days to over 22 years), arterial samples (n=376)įDA:2020P - Pass Infants to Adults (29 days to over 22 years), venous samples (n=375) A Multicenter Evaluation of a Point-of-Care Blood Glucose Meter System in Critically Ill Patients. Nichols JH, Brandler ES, Fantz CR, Fisher K, Goodman MD, Headden G, Hoppensteadt D, Matika R, Peacock WF, Rodrigo J, Schützenmeister A, Swanson JR, Canada-Vilalta C, Miles G, Tran N. Available from: PMC7439437.ġ5197:2013 - Pass General population (Note: Modified protocol: Fewer samples with low and high blood glucose concentrations than recommended. Performance evaluation of three i-SENS glucometers using arterial blood samples compared with the YSI 2300 Glucose Analyzer. eCollection 2018.ĬLSI:2013 - Fail Neonates (Note: Meter is susceptible to interference by low concentrations of galactose that could potentially influence the ability to detect hypoglycaemia.) ![]() Assessment of the performance of blood glucose monitoring systems for monitoring dysglycaemia in neonatal patients. ![]() Available from: PMC3876372.īa Y, Xu J, Yuan L, Zhu H, Yang Y, Lam MM, Zhang S, Xiao M, Xu J, Zhang R, Chen C. ![]() Analytic evaluation of a new glucose meter system in 15 different critical care settings. Mitsios JV, Ashby LA, Haverstick DM, Bruns DE, Scott MG. Is there a suitable point-of-care glucose meter for tight glycemic control? Evaluation of one home-use and four hospital-use meters in an intensive care unit. Gijzen K, Moolenaar DL, Weusten JJ, Pluim HJ, Demir AY.
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