Conference Resources | Abstracts
September 3
rd
– 6
th
, 2014 | Toronto, Canada |
226
P136
Real-life performance evaluation of the New
Generation Enlite™ glucose sensor in patients
with diabetes mellitus
H. Veeze
1
, L.G. Rasmussen
2
, P. Agrawal
3
, A. Zhong
3
, A. Arietta
4
, N. Kooi
4
, S. Liabat
5
, R. Shah
3
, F.
Kaufman
3
1
Diabeter, Center for Pediatric and Adolescent Diabetes Care and Research, Rotterdam, Netherlands,
2
Medtronic R&D Diabetes, Hoersholm, Denmark,
3
Medtronic Diabetes, Northridge, United States,
4
Medtronic Bakken Research Center, Maastricht, Netherlands,
5
Medtronic International Trading Sàrl,
Tolochenaz, Switzerland
Objective:
To assess the overall sensor performance of the New Generation Enlite™ glucose sensor
when used with Paradigm® Veo™ insulin pumps in adult and pediatric patients with Type 1 Diabetes
Mellitus in daily life.
Methods:
This was a single-center, non-interventional analysis of the performance of the New
Generation Enlite glucose sensor. Real-life data from sixty-one subjects (47 pediatrics; mean age 14.4
years; age range 5-53 years) were extracted from the Medtronic CareLink® Personal database over a
5 month period, during which the patients transitioned from the Enlite sensor to the New Generation
Enlite sensor. Performance statistics were calculated by comparing the New Generation Enlite sensor
glucose (SG) values to the values entered into the insulin pump from the patient's blood glucose (BG)
meter.
Results:
During six days of wear the mean agreement rate of within 20% of the SG value to the BG
values was 80.6%, the mean ARD was 13.03%, 96.87% of paired BG-SG values were within the A+B
zones of the Clarke error grid and 98.52% of paired BG-SG values were within the A+B zones of the
consensus Clarke error grid. In comparison, the sensor agreement rate for the previous generation
Enlite sensor was 76.5%, mean ARD was 14.25%, Clarke A+B was 96.84% and consensus Clarke
A+B was 98.26% in different retrospective timeframe. The New Generation Enlite hypoglycemic
accuracy in terms of absolute bias (mean absolute difference, between SG and BG reference) was
14.31mg/dL for BG interval 40-80mg/dL.
Conclusion:
This preliminary analysis showed that the accuracy of the New Generation Enlite sensor
when used in combination with the algorithm of the Paradigm Veo system is satisfactory, in a real-life
setting. Furthermore, the sensor demonstrated consistent performance and accurate readings in the
hypoglycemic range. Further testing is needed to generate sensor accuracy with respect to other
reference methods (e.g. YSI) and used with other algorithms.
