Evaluation of an over-the-counter glycated hemoglobin (A1C) test kit.
J Diabetes Sci Technol
; 4(6): 1495-503, 2010 Nov 01.
Article
en En
| MEDLINE
| ID: mdl-21129346
ABSTRACT
BACKGROUND:
Glycated hemoglobin (A1C) monitoring is an integral component of diabetes management. This study was conducted to evaluate the performance of the A1CNow® SELFCHECK device when used by lay users and health care professionals (HCPs) to measure A1C.METHODS:
Subjects performed two A1CNow SELFCHECK finger-stick self-tests followed by a finger-stick test of the subject's blood by a HCP. The primary endpoint assessed accuracy of the subject and HCP A1CNow SELFCHECK readings. Secondary endpoints included precision, comprehension of instructional material (written material±DVD), and product satisfaction. For accuracy comparison, a venous blood sample was drawn from each subject and tested by laboratory (TOSOH) analysis. Subject comprehension of product instructional material was evaluated via first-time failure (FTF) rate as recorded by the HCP, and subject satisfaction was assessed through written survey.RESULTS:
A total of 110 subjects with (n=93) and without (n=17) diabetes participated. Of 177 subject A1C values, 165 (93.2%) were within the acceptable range of ±13.5% of the laboratory reference value and considered accurate. Regression analysis showed good correlation of subject values to laboratory and HCP results (R2=0.93 for both). The average within-subject coefficient of variation was 4.57% (n=74). The FTF rates with and without instructional DVD were 11.3% (n=56) and 39.6% (n=54), respectively. Subjects with diabetes/prediabetes overwhelmingly indicated that they were "very" to "extremely" likely (93.5%) to discuss their home A1C results with their HCP.CONCLUSIONS:
Lay users found the A1CNow SELFCHECK easy to use, and both lay users and HCPs were able to measure A1C accurately.
Texto completo:
1
Colección:
01-internacional
Banco de datos:
MEDLINE
Asunto principal:
Estado Prediabético
/
Juego de Reactivos para Diagnóstico
/
Hemoglobina Glucada
/
Sistemas de Atención de Punto
/
Diabetes Mellitus Tipo 1
/
Diabetes Mellitus Tipo 2
Tipo de estudio:
Clinical_trials
/
Prognostic_studies
/
Qualitative_research
Límite:
Adolescent
/
Adult
/
Aged
/
Female
/
Humans
/
Male
/
Middle aged
País/Región como asunto:
America do norte
Idioma:
En
Revista:
J Diabetes Sci Technol
Asunto de la revista:
ENDOCRINOLOGIA
Año:
2010
Tipo del documento:
Article
País de afiliación:
Estados Unidos