Hostname: page-component-848d4c4894-p2v8j Total loading time: 0.001 Render date: 2024-05-14T22:38:52.478Z Has data issue: false hasContentIssue false
  • English
  • Français

ExacTech Blood Glucose Meter Clinical Trial

Published online by Cambridge University Press:  28 June 2012

Edward A. Bartkus ,
Mohamud Daya ,
Jerris R. Hedges  and
Jonathan Jui
Edward A. Bartkus*
Affiliation:
Department of Emergency Medicine, Oregon Health Sciences University, Portland, Oregon
Mohamud Daya
Affiliation:
Department of Emergency Medicine, Oregon Health Sciences University, Portland, Oregon
Jerris R. Hedges
Affiliation:
Department of Emergency Medicine, Oregon Health Sciences University, Portland, Oregon
Jonathan Jui
Affiliation:
Department of Emergency Medicine, Oregon Health Sciences University, Portland, Oregon
*
Department of Emergency Medicine, UHN-52, Oregon Health, Sciences University, 3181 SW SamJackson Park Road, Portland, OR 97201-3098USA
Get access Rights & Permissions [Opens in a new window]

Abstract

Introduction:

Current prehospital protocols for the management of patients with altered mental status include the empiric administration of hypertonic glucose, naloxone, and thiamine. The injudicious use of 50% dextrose (D50W) may result in hyperosmolarity, a worsening of hypokalemia, and unwarranted additional health-care costs for the patient. The administration of D50W also may worsen the neurological outcome of patients with local or generalized ischemia.

Objective:

To evaluate the ExacTech blood glucose meter's ability to estimate blood glucose levels accurately and rapidly.

Methods:

Emergency medical technicians (EMTs) from selected advanced life support (ALS) units in the Portland, Ore., metropolitan area participated in a prospective clinical trial of the ExacTech blood glucose meter. A convenience sample, was drawn from emergency medical services (EMS) patients with suspected diabetic emergencies, altered mental status, and other neurological deficits. Venous blood samples were drawn from these populations at the same time as the ExacTech readings were obtained. The venous blood was submitted to the receiving hospitals for laboratory analysis of blood glucose levels, and a comparison was made between the results of the two methods.

Results:

A total of 80 matched sets of data were obtained from 1 April 1990 through 6 May 1991. The hospital blood glucose values ranged from 8 to 1233 mg/dl. Sixteen (20%) of the patients were hypoglycemic (<60 mg/dl) and 23 (28.8%) were hyperglycemic (>180 mg/dl). The ExacTech device sensitivity and specificity for hypoglycemia using venous samples were 94.6% and 89.2%, respectively. For hyperglycemia, these same parameters were 87.5% and 97.1%. Pearson's r over the range of the instrument (40–450 mg/dl) was 0.8656 (p <.001). If the prehospital “definition” of hypoglycemia (for threshold-to-treat) is raised to 65 mg/dl, the device has 100% sensitivity in the sample population.

Conclusion:

The device functioned accurately and consistently in the prehospital environment over a wide range of temperatures, and in the hands of many different individuals.

Keywords

altered mental statusblood glucosediagnostic testsemergency medical serviceshealthcarehyperglycemiahypoglycemialevel of consciousnessmedical devicessensitivity and specificity
Type
Original Research
Information
Prehospital and Disaster Medicine , Volume 8 , Issue 3 , September 1993 , pp. 217 - 227
Copyright
Copyright © World Association for Disaster and Emergency Medicine 1993

Access options

Get access to the full version of this content by using one of the access options below. (Log in options will check for institutional or personal access. Content may require purchase if you do not have access.)

References

1. Longstreth, WT, Inui, TS: High blood glucose level of hospital admission and poor neurological recovery and cardiac arrest. Ann Neurol 1984:15:59–63.CrossRefGoogle ScholarPubMed
2. Pulsinelli, WA, Levy, DE, Sigsbee, B, et al. : Increased damage after ischemic stroke in patients with hyperglycemia with or without established diabetes mellitus. Am J Med 1983;74:540–543.CrossRefGoogle ScholarPubMed
3. Berger, L, Hakim, AM: The association of hyperglycemia with cerebral edema in stroke. Stroke 1986:17:865–871.CrossRefGoogle ScholarPubMed
4. Bellodi, G, Manicardi, V, Malavasi, V, et al. : Hyperglycemia and prognosis of acute myocardial infarction in patients without diabetes mellitus. Am J Cardiol 1989:64:885–888.Google Scholar
5. Browning, RG, Olson, DW, Stueven, HA, Mateer, JR: 50% Dextrose: Antidote or toxin? Ann Emerg Med 1990:19:683–687.Google Scholar
6. Braun, O: DS0W: To give, or not to give? CPRT Dispatch 1991;4:1–5.Google Scholar
7. Cheeley, RD, Joyce, SM: A clinical comparison of the performance of four blood glucose reagent strips. Am J Emerg Med 1990:8:11–15.Google Scholar
8. CAP Survey: Serum Glucose Analysis. College of American Pathologists. 1989:6–7.Google Scholar
9. Tietz, N, Fundamentals of Clinical Chemistry. 2d ed., Philadelphia: W.B. Saunders Co., 1976, p 243.Google Scholar
10. Heine, RJ, Van Der Heyden, EAP, Van der Veen, EA: Responses to human and porcine insulin in healthy subjects. Lancel 1989:946–948.CrossRefGoogle Scholar
11. Pickup, J: Human Insulin: Problems with hypoglycaemia in a few patients, Br Med J 1989;299:991–993.Google Scholar
12. Berger, W, Keller, U, Honegger, B, Jaeggi, E: Warning symptoms of hypoglycemia during treatment with human and porcine insulin in diabetes mellitus. Lancet 1989:1041–1044.Google Scholar
13. Weber, EJ: 911 for hypoglycemia: Is low blood sugar on the rise? CPRT Dispatch 1990;3:3.Google Scholar
14. Koschinsky, T, Dannehl, K, Gries, FA: New approach to technical and clinical evaluation of devices for self-monitoring of blood glucose. Diabetes Care 1988;11:619–629.Google Scholar
15. Guidelines on the use of blood glucose meters and nonmeter blood glucose reagent strips in hospitals. (Committee on Monitoring Devices, Canadian Association of Pathologists) CMAJ 1988;138:27–29.Google Scholar
16. Clarke, WL, Cox, D, Gonder-Fredrick, LA, et al. : Evaluating clinical accuracy of systems for self monitoring of blood glucose. Diabetes Care 1987;10:622–628.CrossRefGoogle ScholarPubMed
17. Consensus Statement on Self-Monitoring of Blood Glucose. American Diabetes Association. Diabetes Care 1987;10:95–99.Google Scholar
18. Odeh, M, Oliven, A, Bassan, H: Transient atrial fibrillation precipitated by hypoglycemia. Ann Emerg Med 1990;19:565–567.Google Scholar
19. Gokhroo, R, Mittal, SR: Electrocardiographic correlates of hyperglycemia in acute myocardial infarction. Int J Cardiol 1989;22:267–269.Google Scholar
20. Daya, M, Young, G: Coma and cerebrovascular syndromes. In: Bosker, G, Schwartz, GR, Jones, JS and Sequeira, M: Geriatric Emergency Medicine. Chicago: Mosby Year Book, 1990. p 125.Google Scholar
21. Matthews, DM, Patrick, AW, Collier, DA, et al. : Awareness and use of glucagon in diabetics treated with insulin. Br Med J 1986;293:367–368.CrossRefGoogle ScholarPubMed
22. Rosen, P, Baker, FJ, Barkin, RM, et al. : Emergency Medicine: Concepts and Clinical Practice. 2d ed., St. Louis: C.V. Mosby Co., c 1988. p 1991.Google Scholar
23. Eriksson, KF, Fex, G, Trell, E: Capillary-venous differences in blood glucose values during oral glucose tolerance test. Clin Chemistry 1983:29:993.Google Scholar
24. Melnik, J, Potter, JL: Variance in capillary and venous glucose levels during a glucose tolerance test. Am J Med Technology 1982;48:543–545.Google Scholar
25. Weiner, CP, Faustich, M, Burns, J, et al. : The relationship between capillary and venous glucose concentration during pregnancy. Am J Obslet Gynecol 1986;155:61–64.Google Scholar
26. Ravel, R: Clinical Laboratory Medicine. 2d ed., Chicago: Year Book Medical Publishers, p 316.Google Scholar
27. Herr, RD, Mertz, PM: Chemstrip reliability declines with ambulance storage. Prehospital and Disaster Medicine 1989;4:64. Abstract.Google Scholar
28. King, G, Steggles, D, Harrop, JS: Performance and storage of reagent strips for measuring blood glucose. Br Med J 1982;285:1165.CrossRefGoogle ScholarPubMed
29. Yealy, DM, Hogya, PT, Paris, PM, Stewart, R: Prehospital glucose estimation using reagent strips. Prehospital and Disaster Medicine 1989:4:63. Abstract.Google Scholar
30. Susler, S, Dougherty, J: Utility and accuracy of glucose reagent strips in an active, physician-supervised EMS system. Prehospital and Disaster Medicine 1989;4:64. Abstract.Google Scholar
31. Raskin, P, Strowig, S, Dudley, J, Ellis, B: ExacTech Accuracy Report, Baxter Healthcare Corporation, (unpublished data).Google Scholar
32. Kinkade, M, Heiser, C: Report on Field blood glucose testing pilot program. San Diego Paramedic Association, (unpublished report).Google Scholar
33. Hoffman, JR, Schringer, DL, Votey, SR, Luo, JS: The empiric use of hypertonic dextrose in patients with altered mental status. Ann Emerg Med 1992;21:20–24.Google Scholar
34. Thompson, RH, Wolford, RW: Development and evaluation of criteria allowing paramedics to treat and release patients presenting with hypoglycemia: A retrospective study. Prehospital and Disaster Medicine 1991;6:309–313.CrossRefGoogle Scholar