Medtronic Enlite
Device Name:
Enlite
Manufacturer:
Medtronic MiniMed Inc., 18000 Devonshire Street, Northridge, CA 91325-1219, UNITED STATES.
Measuring functions:
Blood glucose
Primary Client Use:
Intended for self-measurement and home use
Measurement Site:
Abdomen
Measurement Occurrence:
Continuous measurement
Availability:
Available Currently
Description:
The Medtronic Enlite is an automatic blood glucose meter. Medaval has not found evidence proving the accuracy of its blood glucose measurement technology. Blood glucose measurements are taken from the abdomen. It is intended for self-measurement and home use.
Assessment:
There appears to be no peer-reviewed clinical validation information available on the technology used in the Medtronic Enlite to measure blood glucose.
Recommendations:
Accuracy AssessmentRecommendationBasis
BG Medaval Not recommended This device has not been clinically validated.
Relevant Publications:

Matuleviciene V, Joseph JI, Andelin M, Hirsch IB, Attvall S, Pivodic A, Dahlqvist S, Klonoff D, Haraldsson B, Lind M. A clinical trial of the accuracy and treatment experience of the Dexcom G4 sensor (Dexcom G4 system) and Enlite sensor (guardian REAL-time system) tested simultaneously in ambulatory patients with type 1 diabetes. Diabetes Technol Ther. 2014 Nov;16(11):759-67. Epub: 2014 Sep 18. doi: 10.1089/dia.2014.0238. PMID: 25233297. Available from: PMC4201312.

Measurements from the Medtronic Enlite are compared to those from the Dexcom G4 Platinum, though not in a formal validation.

The authors concluded that patients had a more positive treatment experience with the Dexcom G4 system and that it showed greater accuracy than the Medtronic Enlite system.

Kropff J, Bruttomesso D, Doll W, Farret A, Galasso S, Luijf YM, Mader JK, Place J, Boscari F, Pieber TR, Renard E, DeVries JH. Accuracy of two continuous glucose monitoring systems: a head-to-head comparison under clinical research centre and daily life conditions. Diabetes Obes Metab. 2015 Apr;17(4):343-9. Epub: 2014 Sep 10. doi: 10.1111/dom.12378. PMID: 25132320. Available from: PMC4409843.

Measurements from the Medtronic Enlite are compared to those from the Dexcom G4 Platinum, though not in a formal validation.

Andelin M, Kropff J, Matuleviciene V, Joseph JI, Attvall S, Theodorsson E, Hirsch IB, Imberg H, Dahlqvist S, Klonoff D, Haraldsson B, DeVries JH, Lind M. Assessing the Accuracy of Continuous Glucose Monitoring (CGM) Calibrated With Capillary Values Using Capillary or Venous Glucose Levels as a Reference. J Diabetes Sci Technol. 2016 Jun 28;10(4):876-84. doi: 10.1177/1932296815626724. PMID: 26810924. Available from: PMC4928217. Print 2016 Jul.

The authors concluded that, when assessing the accuracy of CGM devices, it is essential to use the same type of sample for both calibration and reference purposes, as glucose levels from capillary samples are significantly higher than those from venous samples in all glycemic ranges.

Taleb N, Emami A, Suppere C, Messier V, Legault L, Chiasson JL, Rabasa-Lhoret R, Haidar A. Comparison of Two Continuous Glucose Monitoring Systems, Dexcom G4 Platinum and Medtronic Paradigm Veo Enlite System, at Rest and During Exercise. Diabetes Technol Ther. 2016 Sep;18(9):561-7. Epub: 2016 Jun 29. doi: 10.1089/dia.2015.0394. PMID: 27356172.

Measurements from the Medtronic Enlite are compared to those from the Dexcom G4 Platinum, though not in a formal validation.

The authors concluded that the device performances were comparable during rest and physical activity but required a fine-tuning during activity due to lower accuracy.

Vandersluis S, Kabali C, Djalalov S, Gajic-Veljanoski O, Wells D and Holubowich C on behalf of Health Quality Ontario. Continuous Monitoring of Glucose for Type 1 Diabetes: A Health Technology Assessment. Ont Health Technol Assess Ser. 2018 Feb 21;18(2):1-160. PMID: 29541282. Available from: PMC5836597. eCollection 2018.

The publication describes the use of the Dexcom G4 Platinum in a scientific study.