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Published Online: 23 April 2014

Accuracy and Acceptability of the 6-Day Enlite Continuous Subcutaneous Glucose Sensor

Publication: Diabetes Technology & Therapeutics
Volume 16, Issue Number 5

Abstract

Objective: This study evaluated the performance and acceptability of the Enlite® glucose sensor (Medtronic MiniMed, Inc., Northridge, CA).
Subjects and Methods: Ninety adults with type 1 or type 2 diabetes wore two Enlite sensors on the abdomen and/or buttock for 6 days and calibrated them at different frequencies. On Days 1, 3, and 6, accuracy was evaluated by comparison of sensor glucose values with frequently sampled plasma glucose values collected over a 12-h period. Accuracy was assessed at different reference glucose concentrations and during times when absolute glucose concentration rates of change were <1, 1–2, and >2 mg/dL/min. The sensor's ability to detect hypoglycemia or hyperglycemia was evaluated with simulated alerts. Subject satisfaction was evaluated with a 7-point Likert-type questionnaire, with a score of 7 indicating strong agreement.
Results: With abdomen sensors under actual-use calibration (mean, 2.8±0.9 times/day), the overall mean (median) absolute relative difference (ARD) values between sensor and reference values were 13.6% (10.1%); the corresponding buttock sensor ARD values were 15.5% (10.5%). With abdomen sensors under minimal calibration (mean, 1.2±0.9 times/day), the mean (median) ARD values were 14.7% (10.8%). Mean ARD values of abdomen sensors at rates of change of <1, 1–2, and >2 mg/dL/min were 13.6%, 12.9%, and 16.3%, respectively. With abdomen sensors, 79.5% and 94.1% of hypoglycemic and hyperglycemic events, respectively, were correctly detected; 81.9% and 94.9% of hypoglycemic and hyperglycemic alerts, respectively, were confirmed. The failure rates for abdomen and buttock sensors were 19.7% and 13.9%, respectively. Mean responses to survey questions for all subjects related to comfort and ease of use were favorable.
Conclusions: The Enlite sensor provided accurate data at different glucose concentrations and rates of change. Subjects found the sensor comfortable and easy to use.

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References

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Information & Authors

Information

Published In

cover image Diabetes Technology & Therapeutics
Diabetes Technology & Therapeutics
Volume 16Issue Number 5May 2014
Pages: 277 - 283
PubMed: 24758729

History

Published in print: May 2014
Published online: 23 April 2014
Published ahead of print: 7 April 2014

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Authors

Affiliations

Timothy S. Bailey, MD
AMCR Institute, Escondido, California.
Andrew Ahmann, MD
Oregon Health and Sciences University, Portland, Oregon.
Ronald Brazg, MD
Rainier Clinical Research Center, Renton, Washington.
Mark Christiansen, MD
Diablo Clinical Research, Walnut Creek, California.
Satish Garg, MD
Barbara Davis Center for Childhood Diabetes, University of Colorado Denver, Aurora, Colorado.
Elaine Watkins, DO, MSPH
Profil Institute for Clinical Research, Chula Vista, California.
John B. Welsh, MD, PhD
Medtronic MiniMed, Northridge, California.
Scott W. Lee, MD
Medtronic MiniMed, Northridge, California.

Notes

This study is registered at ClinicalTrials.gov with clinical trial registration number NCT01464346.
Portions of this work were presented at the 72nd Scientific Sessions of the American Diabetes Association, held in Philadelphia, Pennsylvania, June 8–12, 2012, the 21st Annual Scientific and Clinical Congress of the American Association of Clinical Endocrinologists, held in Philadelphia, Pennsylvania, May 23–27, 2012, and the 48th Annual Meeting of the European Association for the Study of Diabetes, held in Berlin, Germany, October 1–5, 2012.
Address correspondence to:John B. Welsh, MD, PhDMedtronic MiniMed, Inc.18000 Devonshire StreetNorthridge, CA 91325E-mail: [email protected]

Author Disclosure Statement

T.S.B., A.A., R.B., M.C., S.G., and E.W. have received research support from Medtronic, Inc. T.S.B. has received research support from Abbott, ACON, Alere, Animas, BD, Dexcom, Insulet, Lifescan, Lilly, and Tandem and has received consulting honoraria from Bayer, BD, and Medtronic, Inc. J.B.W. and S.W.L. are employees of Medtronic, Inc.

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