Medizinische Universität Graz Austria/Österreich - Forschungsportal - Medical University of Graz

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Gewählte Publikation:

SHR Neuro Krebs Kardio Lipid

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 [OPEN ACCESS]
Web of Science PubMed PUBMED Central FullText FullText_MUG


Autor/innen der Med Uni Graz:
Mader Julia
Pieber Thomas

Dimensions Citations:

Plum Analytics:
Number of Figures: 2
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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 -

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