Timothy Bailey1, Jane F Wallace2, Carmine Greene2, Scott Pardo2, Daniel Brown2, Brian Pflug2, Leslie J Klaff3. 1. AMCR Institute Inc., 625 West Citracado Parkway, Suite 112, Escondido, CA 92025, United States. Electronic address: tbailey@amcrinstitute.com. 2. Bayer HealthCare LLC, Diabetes Care, 100 Bayer Boulevard, P.O. Box 915, Whippany, NJ 07981, United States. 3. Rainier Clinical Research Center, 723 SW 10th St, Renton, WA 98057, United States.
Abstract
BACKGROUND: The Contour(®) Next Link 2.4 blood glucose monitoring system (BGMS), which communicates wirelessly exclusively with a Medtronic insulin pump, was assessed in 2 separate studies. METHODS: In the laboratory study (N=100), subject capillary fingertip samples were tested in duplicate using 3 test strip lots; accuracy was assessed based on ISO 15197:2013 section 6.3 accuracy criteria (95% within ±15mg/dl or ±15% of reference for glucose <100 and ≥100mg/dl, respectively). In the clinical trial (N=219), untrained subjects with diabetes tested capillary fingertip and palm blood samples and completed an ease-of-use questionnaire. BGMS and YSI glucose analyzer results were compared based on ISO 15197:2013 section 8 accuracy criteria. RESULTS: In the laboratory study, 100% of results met ISO 15197:2013 section 6.3 accuracy criteria. In the clinical trial, 98.6% of capillary fingertip and 97.2% of palm results from subjects met ISO 15197:2013 section 8 accuracy criteria. By Parkes-Consensus Error Grid analysis, 100% of subject capillary fingertip results were within Zone A. Based on questionnaire results, the majority of subjects found the BGMS easy to use. CONCLUSIONS: The BGMS exceeds ISO 15197:2013 section 6.3 and section 8 accuracy criteria in the laboratory and in the hands of untrained users with diabetes.
BACKGROUND: The Contour(®) Next Link 2.4 blood glucose monitoring system (BGMS), which communicates wirelessly exclusively with a Medtronic insulin pump, was assessed in 2 separate studies. METHODS: In the laboratory study (N=100), subject capillary fingertip samples were tested in duplicate using 3 test strip lots; accuracy was assessed based on ISO 15197:2013 section 6.3 accuracy criteria (95% within ±15mg/dl or ±15% of reference for glucose <100 and ≥100mg/dl, respectively). In the clinical trial (N=219), untrained subjects with diabetes tested capillary fingertip and palm blood samples and completed an ease-of-use questionnaire. BGMS and YSI glucose analyzer results were compared based on ISO 15197:2013 section 8 accuracy criteria. RESULTS: In the laboratory study, 100% of results met ISO 15197:2013 section 6.3 accuracy criteria. In the clinical trial, 98.6% of capillary fingertip and 97.2% of palm results from subjects met ISO 15197:2013 section 8 accuracy criteria. By Parkes-Consensus Error Grid analysis, 100% of subject capillary fingertip results were within Zone A. Based on questionnaire results, the majority of subjects found the BGMS easy to use. CONCLUSIONS: The BGMS exceeds ISO 15197:2013 section 6.3 and section 8 accuracy criteria in the laboratory and in the hands of untrained users with diabetes.
Authors: Amin Sharifi; Andrea Varsavsky; Johanna Ulloa; Jodie C Horsburgh; Sybil A McAuley; Balasubramanian Krishnamurthy; Alicia J Jenkins; Peter G Colman; Glenn M Ward; Richard J MacIsaac; Rajiv Shah; David N O'Neal Journal: J Diabetes Sci Technol Date: 2016-05-03
Authors: Katrin Nagl; Gabriele Berger; Felix Aberer; Haris Ziko; Katharina Weimann; Ina Bozic; Birgit Rami-Merhar; Julia K Mader Journal: Pediatr Diabetes Date: 2020-12-04 Impact factor: 4.866