Accuracy and acceptability of the 6-day enlite continuous subcutaneous glucose sensor

Timothy S. Bailey, Andrew Ahmann, Ronald Brazg, Mark Christiansen, Satish Garg, Elaine Watkins, John B. Welsh, Scott W. Lee

Research output: Contribution to journalArticle

51 Citations (Scopus)

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 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 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.

Original languageEnglish (US)
Pages (from-to)277-283
Number of pages7
JournalDiabetes Technology and Therapeutics
Volume16
Issue number5
DOIs
StatePublished - May 1 2014

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Abdomen
Glucose
Buttocks
Hypoglycemic Agents
Calibration
Aptitude
Hypoglycemia
Hyperglycemia
Type 2 Diabetes Mellitus
Reference Values
Surveys and Questionnaires

ASJC Scopus subject areas

  • Endocrinology
  • Endocrinology, Diabetes and Metabolism
  • Medical Laboratory Technology
  • Medicine(all)

Cite this

Bailey, T. S., Ahmann, A., Brazg, R., Christiansen, M., Garg, S., Watkins, E., ... Lee, S. W. (2014). Accuracy and acceptability of the 6-day enlite continuous subcutaneous glucose sensor. Diabetes Technology and Therapeutics, 16(5), 277-283. https://doi.org/10.1089/dia.2013.0222

Accuracy and acceptability of the 6-day enlite continuous subcutaneous glucose sensor. / Bailey, Timothy S.; Ahmann, Andrew; Brazg, Ronald; Christiansen, Mark; Garg, Satish; Watkins, Elaine; Welsh, John B.; Lee, Scott W.

In: Diabetes Technology and Therapeutics, Vol. 16, No. 5, 01.05.2014, p. 277-283.

Research output: Contribution to journalArticle

Bailey, TS, Ahmann, A, Brazg, R, Christiansen, M, Garg, S, Watkins, E, Welsh, JB & Lee, SW 2014, 'Accuracy and acceptability of the 6-day enlite continuous subcutaneous glucose sensor', Diabetes Technology and Therapeutics, vol. 16, no. 5, pp. 277-283. https://doi.org/10.1089/dia.2013.0222
Bailey, Timothy S. ; Ahmann, Andrew ; Brazg, Ronald ; Christiansen, Mark ; Garg, Satish ; Watkins, Elaine ; Welsh, John B. ; Lee, Scott W. / Accuracy and acceptability of the 6-day enlite continuous subcutaneous glucose sensor. In: Diabetes Technology and Therapeutics. 2014 ; Vol. 16, No. 5. pp. 277-283.
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