Medizinische Universität Graz - Research portal

Go directly to the nagivation.
Go directly to the content.

Navigation/Search

Selected Publication:

SHR Neuro Cancer Cardio Lipid Metab Microb

Thabit, H; Leelarathna, L; Wilinska, ME; Elleri, D; Allen, JM; Lubina-Solomon, A; Walkinshaw, E; Stadler, M; Choudhary, P; Mader, JK; Dellweg, S; Benesch, C; Pieber, TR; Arnolds, S; Heller, SR; Amiel, SA; Dunger, D; Evans, ML; Hovorka, R.
Accuracy of Continuous Glucose Monitoring During Three Closed-Loop Home Studies Under Free-Living Conditions.
Diabetes Technol Ther. 2015; 17(11):801-807 Doi: 10.1089/dia.2015.0062 [OPEN ACCESS]
Web of Science PubMed FullText FullText_MUG

Co-authors Med Uni Graz: Mader Julia; Pieber Thomas
Altmetrics:
Dimensions Citations:
Plum Analytics:
Scite (citation analytics):
Abstract:: Closed-loop (CL) systems modulate insulin delivery based on glucose levels measured by a continuous glucose monitor (CGM). Accuracy of the CGM affects CL performance and safety. We evaluated the accuracy of the Freestyle Navigator(®) II CGM (Abbott Diabetes Care, Alameda, CA) during three unsupervised, randomized, open-label, crossover home CL studies. Paired CGM and capillary glucose values (10,597 pairs) were collected from 57 participants with type 1 diabetes (41 adults [mean±SD age, 39±12 years; mean±SD hemoglobin A1c, 7.9±0.8%] recruited at five centers and 16 adolescents [mean±SD age, 15.6±3.6 years; mean±SD hemoglobin A1c, 8.1±0.8%] recruited at two centers). Numerical accuracy was assessed by absolute relative difference (ARD) and International Organization for Standardization (ISO) 15197:2013 15/15% limits, and clinical accuracy was assessed by Clarke error grid analysis. Total duration of sensor use was 2,002 days (48,052 h). Overall sensor accuracy for the capillary glucose range (1.1-27.8 mmol/L) showed mean±SD and median (interquartile range) ARD of 14.2±15.5% and 10.0% (4.5%, 18.4%), respectively. Lowest mean ARD was observed in the hyperglycemic range (9.8±8.8%). Over 95% of pairs were in combined Clarke error grid Zones A and B (A, 80.1%, B, 16.2%). Overall, 70.0% of the sensor readings satisfied ISO criteria. Mean ARD was consistent (12.3%; 95% of the values fall within ±3.7%) and not different between participants (P=0.06) within the euglycemic and hyperglycemic range, when CL is actively modulating insulin delivery. Consistent accuracy of the CGM within the euglycemic-hyperglycemic range using the Freestyle Navigator II was observed and supports its use in home CL studies. Our results may contribute toward establishing normative CGM performance criteria for unsupervised home use of CL.
Find related publications in this database (using NLM MeSH Indexing): Adolescent -; Adult -; Blood Glucose - analysis; Blood Glucose Self-Monitoring - instrumentation; Blood Glucose Self-Monitoring - standards; Child -; Cross-Over Studies -; Diabetes Mellitus, Type 1 - blood; Diabetes Mellitus, Type 1 - complications; Diabetes Mellitus, Type 1 - drug therapy; Equipment Design -; Female -; Glycated Hemoglobin A - analysis; Humans -; Hypoglycemia - diagnosis; Hypoglycemia - drug therapy; Hypoglycemia - etiology; Hypoglycemic Agents - administration & dosage; Insulin - administration & dosage; Insulin Infusion Systems - standards; Male -; Middle Aged -; Reference Values -; Reproducibility of Results -; Social Conditions -; Teach-Back Communication -; Time Factors -