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Nova StatStrip Glu
Manufacturer:
Nova Biomedical Corporation, 200 Prospect St, Waltham, MA 02454-9141, UNITED STATES.
Measuring functions:
Blood glucose
Primary Client Use:
Intended for professional use
Measurement Site:
Finger
Measurement Occurrence:
Single measurements only
Availability:
Available Currently
Description:
The Nova StatStrip Glu is an automatic blood glucose meter. Its blood glucose measurement technology has been proven to be accurate, with a 1-star Medaval rating. Blood glucose measurements are taken from the finger and it is intended for professional use.
Assessment:
The technology used in the Nova StatStrip Glu, to measure blood glucose, has passed in three clinical validation studies, between general and young populations, according to recognised standard protocols, as published in peer-reviewed publications.
Recommendations:
Accuracy AssessmentRecommendationBasis
Medaval Recommendation Older clinical validation; older protocol; multiple clinical validations
MDR Criteria Adults Validation with amended protocol - may require further study
Validation Publications:

Kost GJ, Tran NK, Louie RF, Gentile NL, Abad VJ. Assessing the performance of handheld glucose testing for critical care. Diabetes Technol Ther. 2008 Dec;10(6):445-51. doi: 10.1089/dia.2008.0049. PMID: 19049373. Available from: PMC2693242.

15197:2003 - Pass General population

de Mol P, Krabbe HG, de Vries ST, Fokkert MJ, Dikkeschei BD, Rienks R, Bilo KM, Bilo HJ. Accuracy of handheld blood glucose meters at high altitude. PLoS One. 2010 Nov 12;5(11):e15485. doi: 10.1371/journal.pone.0015485. PMID: 21103399.

Ad Hoc protocol - Pass High Altitude (Note: Simulated altitude in hypobarbic chamber)

Only "Nova StatStrip" is stated in the paper. The "Nova StatStrip Glu" is inferred.

Makaya T, Memmott A, Bustani P. Point-of-care glucose monitoring on the neonatal unit. J Paediatr Child Health. 2012 Apr;48(4):342-6. Epub: 2011 Nov 23. doi: 10.1111/j.1440-1754.2011.02253.x. PMID: 22112143.

15197:2003 - Pass General population

Nuntnarumit P, Chittamma A, Pongmee P, Tangnoo A, Goonthon S. Clinical performance of the new glucometer in the nursery and neonatal intensive care unit. Pediatr Int. 2011 Apr;53(2):218-223. doi: 10.1111/j.1442-200X.2010.03214.x. PMID: 21501305.

Unknown protocol Neonates

Protocol not stated in abstract.

Gijzen K, Moolenaar DL, Weusten JJ, Pluim HJ, Demir AY. 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. Clin Chem Lab Med. 2012 Nov;50(11):1985-92. PMID: 22718643.

15197:2003 - Fail General population

Tendl KA, Christoph J, Bohn A, Herkner KR, Pollak A, Prusa AR. Two site evaluation of the performance of a new generation point-of-care glucose meter for use in a neonatal intensive care unit. Clin Chem Lab Med. 2013 Sep;51(9):1747-54. doi: 10.1515/cclm-2012-0864. PMID: 23612555.

Ad Hoc protocol Neonates (Note: Protocol not stated in abstract.)

Only "Nova StatStrip" is stated in the abstract. The "Nova StatStrip Glu" is inferred.

Wada Y, Nakamura T, Kaneshige M, Takahashi S, Fujinaga H, Tsukamoto K, Ito Y, Sago H. Evaluation of two glucose meters and interference corrections for screening neonatal hypoglycemia. Pediatr Int. 2015 Aug;57(4):603-7. Epub: 2015 Feb 11. doi: 10.1111/ped.12543. PMID: 25441549.

Ad Hoc protocol Neonates

Only "Nova StatStrip" is stated in the abstract. The "Nova StatStrip Glu" is inferred.

Cho J, Ahn S, Yim J, Cheon Y, Jeong SH, Lee SG, Kim JH. Influence of Vitamin C and Maltose on the Accuracy of Three Models of Glucose Meters. Ann Lab Med. 2016 May;36(3):271-4. doi: 10.3343/alm.2016.36.3.271. PMID: 26915620. Available from: PMC4773272. Letter.

15197:2013 Validation with maltose interference (Note: No significant intereference at any maltose concentration was noted.)

15197:2013 Validation with high Vit C (30 mg/dl) concentrations (Note: Device malfuctioned occasionally at high Vt C concentrations.)

This paper refers to a "Nova StarStrip". The "Nova StatStrip Glu" is inferred.

Karon BS, Donato LJ, Larsen CM, Siebenaler LK, Wells AE, Wood-Wentz CM, Shirk-Marienau ME, Curry TB. Accuracy of Capillary and Arterial Whole Blood Glucose Measurements Using a Glucose Meter in Patients under General Anesthesia in the Operating Room. Anesthesiology. 2017 Sep;127(3):466-474. doi: 10.1097/ALN0000000000001708. PMID: 28557817. Available from: PMC5561475.

CLSI:2013 - Fail Patients under general anaesthesia, Arterial samples

CLSI:2013 - Fail Patients under general anaesthesia, Capilliary samples

Capillary and arterial blood glucose measured using the glucose meter are acceptable for intraoperative subcutaneous insulin dosing. Whole blood glucose on the meter did not meet accuracy guidelines established specifically for more intensive (e.g. intravenous insulin) glycemic control in the acute care environment.

Ba Y, Xu J, Yuan L, Zhu H, Yang Y, Lam MM, Zhang S, Xiao M, Xu J, Zhang R, Chen C. Assessment of the performance of blood glucose monitoring systems for monitoring dysglycaemia in neonatal patients. BMJ Paediatr Open. 2018 Oct 23;2(1):e000339. doi: 10.1136/bmjpo-2018-000339. PMID: 30397671. Available from: PMC6203032. eCollection 2018.

CLSI:2013 - Pass Neonates

CMA:2016 - Pass Neonates

Relevant Publications:

Musholt PB, Schipper C, Thomé N, Ramljak S, Schmidt M, Forst T, Pfützner A. Dynamic electrochemistry corrects for hematocrit interference on blood glucose determinations with patient self-measurement devices. J Diabetes Sci Technol. 2011 Sep 1;5(5):1167-75. doi: 10.1177/193229681100500520. PMID: 22027312. Available from: PMC3208875.

Reliable correction for potential haematocrit influence.

Perera NJ, Molyneaux L, Constantino MI, McGill M, Yue DK, Twigg SM, Ross GP. Suboptimal performance of blood glucose meters in an antenatal diabetes clinic. Diabetes Care. 2011 Feb;34(2):335-337. Epub: 2011 Jan 7. doi: 10.2337/dc10-1457. PMID: 21216849. Available from: PMC3024344.

The publication evaluates the performance of the Nova StatStrip (Glu), though not in a formal validation.

Lv H, Zhang GJ, Kang XX, Yuan H, Lv YW, Wang WW, Randall R. Factors interfering with the accuracy of five blood glucose meters used in Chinese hospitals. J Clin Lab Anal. 2013 Sep;27(5):354-66. doi: 10.1002/jcla.21611. PMID: 24038220.

The publication evaluates the performance of the Nova StatStrip (Glu), though not in a formal validation.

Only "Nova StatStrip" is stated in the abstract. The "Nova StatStrip Glu" is inferred.

Vučić Lovrenčić M, Radišić Biljak V, Božičević S, Pape-Medvidović E, Ljubić S. Validation of Point-of-Care Glucose Testing for Diagnosis of Type 2 Diabetes. Int J Endocrinol. 2013;2013:206309. Epub: 2013 Dec 8. doi: 10.1155/2013/206309. PMID: 24382960. Available from: PMC3870641.

The publication evaluates the performance of the Nova StatStrip (Glu), though not in a formal validation.

Karon BS, Blanshan CT, Deobald GR, Wockenfus AM. Retrospective evaluation of the accuracy of Roche AccuChek Inform and Nova StatStrip glucose meters when used on critically ill patients. Diabetes Technol Ther. 2014 Dec;16(12):828-32. Epub: 2014 Aug 5. doi: 10.1089/dia.2014.0074. PMID: 25093919.

The publication evaluates the performance of the Nova StatStrip (Glu), though not in a formal validation.

Only "Nova StatStrip" is stated in the abstract. The "Nova StatStrip Glu" is inferred.

Lockyer MG, Fu K, Edwards RM, Collymore L, Thomas J, Hill T, Devaraj S. Evaluation of the Nova StatStrip glucometer in a pediatric hospital setting. Clin Biochem. 2014 Jun;47(9):840-843. Epub: 2014 Jan 20. doi: 10.1016/j.clinbiochem.2014.01.004. PMID: 24457064.

Measurements from the Nova StatStrip (Glu) are compared to those from Roche Accu-Chek Inform, though not in a formal validation.

Huang E, Demirel S, Bliss C, Savaser D, Castle JR. Reliability of the Dexcom G6 Continuous Glucose Monitor During Hyperbaric Oxygen Exposure. Diabetes Technol Ther. 2020 May;22(5):360-366. Epub: 2020 Feb 6. doi: 10.1089/dia20190390. PMID: 31916854. Available from: PMC7196364.

In those without DM, exposure to hyperbaric oxygen was associated with a statistically significant and potentially clinically relevant decrease in glucose estimate reported by the Novastat glucometer. (n=26)