Dataset Information

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

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.

SUBMITTER: Thabit H

PROVIDER: S-EPMC4649721 | biostudies-literature | 2015 Nov

REPOSITORIES: biostudies-literature

ACCESS DATA

Publications

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

Thabit Hood H Leelarathna Lalantha L Wilinska Malgorzata E ME Elleri Daniella D Allen Janet M JM Lubina-Solomon Alexandra A Walkinshaw Emma E Stadler Marietta M Choudhary Pratik P Mader Julia K JK Dellweg Sibylle S Benesch Carsten C Pieber Thomas R TR Arnolds Sabine S Heller Simon R SR Amiel Stephanie A SA Dunger David D Evans Mark L ML Hovorka Roman R

Diabetes technology & therapeutics 20150804 11

<h4>Objectives</h4>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.<h4>Materials and methods</h4>Paired CGM and capillary glucose values (10,597 pairs) were collected from 57 participants with t ...[more]

PMID: 26241693

Similar Datasets

Project description:BackgroundAdvances in diabetes technology have been exponential in the last few decades. With evolution in continuous glucose monitoring (CGM) systems and its progressive automation in control of insulin delivery, these advances have changed type 1 diabetes mellitus (T1DM) management. These novel technologies have the potential to improve glycated haemoglobin (HbA1c), reduce hypoglycaemic events, increase time spent in range and improve quality of life (QoL). Our aim was to evaluate the sustained effects in free-living unsupervised conditions of CGM systems (intermittently scanned and real time) and insulin delivery [from multiple daily injections, via sensor-augmented pump therapy and (predictive) low-glucose insulin suspension to hybrid closed-loop systems] on glucose control and QoL in adults and children with T1DM.MethodsWe performed a systematic review of randomized controlled trials (RCTs), using PubMed and the Cochrane library up to 30 May 2019. Inclusion of RCTs was based on type of intervention (comparing glucose-monitoring devices and insulin-delivery devices), population (nonpregnant adults and children with T1DM), follow-up (outpatient setting for at least 8 weeks) and relevant outcomes [HbA1c, time in range (TIR), time in target, time in hypoglycaemia and QoL]. Exclusion of RCTs was based on intervention (exercise, only overnight use). The Preferred Reporting Items for Systematic reviews and Meta-Analyses guidelines were used to score the quality of the papers and for the final selection of the articles.ResultsOur search resulted in 214 articles, of which 19 were eligible. Studies on advanced use in adults and children with T1DM reported increased TIR (all 9 studies); decreased time in hypoglycaemia (13 out of 15 studies); lowered HbA1c levels (5 out of 15 studies); improved QoL (10 of 16 studies) and treatment satisfaction (7 studies).ConclusionsRecent technologies have dramatically changed the course of T1DM. They are proving useful in controlling glycaemia in patients with T1DM, without increasing the treatment burden.

Dataset Information

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

Publications

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

Similar Datasets

OmicsDI is part of the ELIXIR infrastructure

Tweets