Repository logo
 

Accuracy of Continuous Glucose Monitoring During Three Closed-Loop Home Studies Under Free-Living Conditions.


Change log

Authors

Thabit, Hood 
Leelarathna, Lalantha 
Wilinska, Malgorzata E 
Elleri, Daniella 
Allen, Janet M 

Abstract

OBJECTIVES: 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. MATERIALS AND METHODS: 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. RESULTS: 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. CONCLUSIONS: 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.

Description

Keywords

Adolescent, Adult, Blood Glucose, Blood Glucose Self-Monitoring, Child, Cross-Over Studies, Diabetes Mellitus, Type 1, Equipment Design, Female, Glycated Hemoglobin, Humans, Hypoglycemia, Hypoglycemic Agents, Insulin, Insulin Infusion Systems, Male, Middle Aged, Reference Values, Reproducibility of Results, Social Conditions, Teach-Back Communication, Time Factors

Journal Title

Diabetes Technol Ther

Conference Name

Journal ISSN

1520-9156
1557-8593

Volume Title

17

Publisher

Mary Ann Liebert Inc
Sponsorship
Wellcome Trust (100574/Z/12/Z)
National Institute of Diabetes and Digestive and Kidney Diseases (R01DK085621)
European Commission (247138)
Juvenile Diabetes Research Foundation (#22-2009-802), Diabetes UK (BDA07/0003549) and Seventh Framework Programme of the European Union (Grant Agreement number 247138) with additional support for the Artificial Pancreas work by National Institute of Diabetes and Digestive and Kidney Diseases (1R01DK085621), Wellcome Strategic Award (100574/Z/12/Z), and National Institute for Health Research Cambridge Biomedical Research Centre.