Document Detail


Accuracy of newer-generation home blood glucose meters in a Diabetes Research in Children Network (DirecNet) inpatient exercise study.
MedLine Citation:
PMID:  16241867     Owner:  NLM     Status:  MEDLINE    
Abstract/OtherAbstract:
BACKGROUND: The objective of this study was to assess how the accuracy of the FreeStyle Flash (Abbott Diabetes Care, Alameda, CA) meter compares with that of the One Touch Ultra (Lifescan, Milpitas, CA) home glucose meter (HGM).
RESEARCH DESIGN AND METHODS: Fifty children with type 1 diabetes (T1D), 10-17 years old, were admitted for two separate 24-h periods to assess the effect of exercise on subsequent nocturnal hypoglycemia. Resulting data were used in a preplanned analysis of the accuracy of the Ultra and FreeStyle HGMs. Glucose levels were measured throughout the day and night and every 15-20 min during a standardized exercise protocol. Reference samples were assayed in a central laboratory using a hexokinase enzymatic method. These reference glucose measurements were paired with HGM values from venous blood obtained within +/- 5 min.
RESULTS: The median relative absolute difference was 5% for both the Ultra and FreeStyle HGMs, and the percentages of pairs meeting the International Organisation for Standardization criteria were 99% and 98%, respectively. The FreeStyle tended to read slightly higher than the reference method (median difference = +3 mg/dL; P < 0.001), and there was trend in this direction for the Ultra (median difference = +2 mg/dL, P = 0.15). Sensitivities for detection of hypoglycemia (reference < or = 60 and HGM < or = 70 mg/dL) were 96% and 100% for the Ultra and FreeStyle, respectively, and corresponding false-positive rates were both 5%.
CONCLUSIONS: In a controlled clinical setting using venous blood samples, both the Ultra and FreeStyle meters demonstrated a high degree of accuracy compared with the laboratory reference over a broad range of glucose concentrations in children with T1D.
Authors:
Stuart A Weinzimer; Roy W Beck; H Peter Chase; Larry A Fox; Bruce A Buckingham; William V Tamborlane; Craig Kollman; Julie Coffey; Dongyuan Xing; Katrina J Ruedy;
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Publication Detail:
Type:  Comparative Study; Evaluation Studies; Journal Article; Multicenter Study; Research Support, N.I.H., Extramural    
Journal Detail:
Title:  Diabetes technology & therapeutics     Volume:  7     ISSN:  1520-9156     ISO Abbreviation:  Diabetes Technol. Ther.     Publication Date:  2005 Oct 
Date Detail:
Created Date:  2005-10-24     Completed Date:  2006-02-01     Revised Date:  2014-09-24    
Medline Journal Info:
Nlm Unique ID:  100889084     Medline TA:  Diabetes Technol Ther     Country:  United States    
Other Details:
Languages:  eng     Pagination:  675-80; discussion 681-3     Citation Subset:  IM    
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MeSH Terms
Descriptor/Qualifier:
Adolescent
Blood Glucose / analysis*
Blood Glucose Self-Monitoring / instrumentation*,  standards
Child
Diabetes Mellitus, Type 1 / blood*
Exercise / physiology*
False Negative Reactions
Female
Humans
Hypoglycemia / diagnosis*
Male
Reproducibility of Results
Sensitivity and Specificity
Grant Support
ID/Acronym/Agency:
HD041890/HD/NICHD NIH HHS; HD041906/HD/NICHD NIH HHS; HD041908/HD/NICHD NIH HHS; HD041915/HD/NICHD NIH HHS; HD041918/HD/NICHD NIH HHS; HD041919/HD/NICHD NIH HHS; M01 RR000069/RR/NCRR NIH HHS; M01 RR00069/RR/NCRR NIH HHS; RR00059/RR/NCRR NIH HHS; RR00070/RR/NCRR NIH HHS; RR00125/RR/NCRR NIH HHS; U01 HD041890/HD/NICHD NIH HHS; U10 HD041906/HD/NICHD NIH HHS; U10 HD041915/HD/NICHD NIH HHS; U10 HD041918/HD/NICHD NIH HHS
Chemical
Reg. No./Substance:
0/Blood Glucose
Comments/Corrections

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