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A Clinical Trial of the Accuracy and Treatment Experience of the Flash Glucose Monitor FreeStyle Libre in Adults with Type 1 Diabetes
NU Hospital Grp, Sweden; University of Gothenburg, Sweden.
Sahlgrens University Hospital, Sweden; University of Gothenburg, Sweden.
Sahlgrens University Hospital, Sweden.
NU Hospital Group, Uddevalla, Sweden.
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2017 (English)In: Diabetes Technology & Therapeutics, ISSN 1520-9156, E-ISSN 1557-8593, Vol. 19, no 3, 164-172 p.Article in journal (Refereed) Published
Abstract [en]

Background: In Sweden, FreeStyle Libre a flash glucose monitoring system came onto the market in 2014 as a complement to self-monitoring of blood glucose. The aim of this study was to evaluate the accuracy and treatment experience of the FreeStyle Libre system. Methods: Fifty-eight adults with type 1 diabetes used FreeStyle Libre for 10-14 days and measured capillary blood glucose levels with the HemoCue blood glucose measurement system at least six times a day simultaneously. Results: For the entire study period, the mean absolute relative difference (MARD) was 13.2% (95% confidence interval [CI] 12.0%-14.4%). MARD was 13.6% (95% CI 12.1%-15.4%) during week 1 and 12.7% (95% CI 11.5%-13.9%) during week 2. The mean absolute difference (MAD) for the whole study period was 19.8mg/dL (1.1mmol/L) (95% CI 17.8-21.8 mg/dL), including 20.5 mg/dL (1.14 mmol/L) during week 1 and 19.0 mg/dL (1.05 mmol/L) during week 2. The overall correlation coefficient was 0.96. For glucose values amp;lt; 72, 72-180, and amp;gt; 180mg/dL (amp;lt; 4, 4-10, and amp;gt; 10 mmol/L), the MARD was 20.3% (95% CI 17.7%-23.1%), 14.7% (95% CI 13.4%-16%), and 9.6% (95% CI 8.5%-10.8%), respectively, and respective MAD values were 12.3, 17.8, and 23.6 mg/dL (0.69, 0.99, and 1.31mmol/L). Using the 10-item visual analog scale, patients rated their experience with FreeStyle Libre as generally positive, with mean values ranging from 8.22 to 9.8. Conclusions: FreeStyle Libre had a similar overall MARD as continuous blood glucose monitoring systems in earlier studies when studied in similar at-home conditions. The overall patient satisfaction was high.

Place, publisher, year, edition, pages
MARY ANN LIEBERT, INC , 2017. Vol. 19, no 3, 164-172 p.
Keyword [en]
Diabetes mellitus; Flash glucose monitor; Accuracy
National Category
Biomedical Laboratory Science/Technology
Identifiers
URN: urn:nbn:se:liu:diva-136611DOI: 10.1089/dia.2016.0392ISI: 000396223600006PubMedID: 28263665OAI: oai:DiVA.org:liu-136611DiVA: diva2:1089932
Note

Funding Agencies|Novo Nordisk Foundation; Swedish state; Health & Medical Care Committee of the regional Executive Board, Region Vastra Gotaland, Sweden; Fyrbodal Research and Development Council, Region Vastra Gotaland, Sweden

Available from: 2017-04-21 Created: 2017-04-21 Last updated: 2017-04-21

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CiteExportLink to record
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