| Accuracy of the Enlite 6-Day Glucose Sensor with Guardian and Veo Calibration Algorithms. | |
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MedLine Citation:
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PMID: 22145851 Owner: NLM Status: Publisher |
Abstract/OtherAbstract:
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Abstract Objective: This study investigates the accuracy of a newly developed, next-generation subcutaneous glucose sensor, evaluated for 6-day use. Research Design and Methods: Seventy-nine subjects (53 men, 26 women) with type 1 diabetes and 18 subjects (14 men, four women) with type 2 diabetes completed a three-center, prospective, sensor accuracy study. The mean age for the group was 42.2±15.0 years (mean±SD), ranging from 18 to 71 years, with a mean glycosylated hemoglobin level of 7.6±1.5%, ranging from 5.5% to 14%. Subjects wore Enlite(™) sensors (Medtronic Diabetes, Northridge, CA) in the abdominal and buttocks region for two separate 7-day periods and calibrated with a home-use blood glucose meter. Subjects participated in an in-clinic testing day where frequent sampled plasma glucose samples were acquired every 15 min for 10 h. Sensor data was retrospectively processed with Guardian(®) REAL-Time (Medtronic) and Paradigm(®) Veo(™) (Medtronic) calibration routines, and accuracy metrics were calculated for each algorithm and sensor location. Physiological time lag for each measurement site was calculated. Results: Based on 6,404 plasma-sensor glucose paired points, the Enlite sensor with Veo calibration algorithm produced a mean absolute relative difference of 13.86% with 97.3% of points within the A+B zones of the Clarke error grid. Threshold-only alarms detected 90.1% of hypoglycemia and 90% of hyperglycemia. Mean time lag measured at the abdominal region was 7.94±6.48 min compared with 11.70±6.71 min (P<0.0001) at the buttocks area. Conclusions: The Enlite sensor accurately measures glucose when compared with gold standard laboratory measurements over its 6-day use. Sensors placed in the buttocks region exhibited greater time lags than sensors placed in the abdomen. |
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Authors:
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Desmond Barry Keenan; John Joseph Mastrototaro; Howard Zisser; Kenneth A Cooper; Gautham Raghavendhar; Scott W Lee; Jonathan Yusi; Timothy Bailey; Ronald Leonard Brazg; Rajiv V Shah |
Publication Detail:
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Type: JOURNAL ARTICLE Date: 2011-12-6 |
Journal Detail:
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Title: Diabetes technology & therapeutics Volume: - ISSN: 1557-8593 ISO Abbreviation: - Publication Date: 2011 Dec |
Date Detail:
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Created Date: 2011-12-7 Completed Date: - Revised Date: - |
Medline Journal Info:
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Nlm Unique ID: 100889084 Medline TA: Diabetes Technol Ther Country: - |
Other Details:
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Languages: ENG Pagination: - Citation Subset: - |
Affiliation:
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1 Medtronic Diabetes, R&D , Northridge, California. |
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From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine
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