A Clinical Trial of the Accuracy and Treatment Experience of the Flash Glucose Monitor FreeStyle Libre in Adults with Type 1 Diabetes
Open accessAbstract
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 19.8 mg/dL (1.1 mmol/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 <72, 72–180, and >180 mg/dL (<4, 4–10, and >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 1.31 mmol/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.
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The FSL's mean absolute relative difference compared with measured capillary blood glucose levels was 13.2% (95% CI 12.0% to 14.4%).
“One study showed that the FSL’s mean absolute relative difference compared with measured capillary blood glucose levels was 13.2% (95% CI 12.0% to 14.4%) [29].”
From Wearable Technology to Quantify the Nutritional Intake of Adults: Validation Study (2020) · cites this paper as [29]
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- Authors
- Ólafsdóttir, A. F., Attvall, S., Sandgren, U., Dahlqvist, S., Pivodic, A., Skrtic, S., Theodorsson, E., & Lind, M.
- Affiliations
- NU Hospital Group (SE)
- Sahlgrenska University Hospital (SE)
- Statistiska Konsultgruppen
- AstraZeneca (United Kingdom) (GB)
- Linköping University (SE)
- Corresponding author
- Ólafsdóttir, Arndís F.
- ORCID
- Venue
- Diabetes Technology & Therapeutics
- Publisher
- SAGE Publications
- Published
- 2017-03
- Volume
- 19
- Issue
- 3
- Pages
- 164-172
- ISSN
- 1520-9156 (ISSN-L)
- 1557-8593
- PMC
- PMC5359691
- OpenAlex
- W2597477321
- Cited by
- 173
- References
- 18
- Citations by year
- 2026: 6 · 2025: 8 · 2024: 9 · 2023: 10 · 2022: 23 · 2021: 19 · 2020: 33 · 2019: 24 · 2018: 31 · 2017: 10
- FWCI
- 21.17
- Type
- journal article
- Language
- en
- Open access
- hybrid
- doi.org
- Licence
- Locations
- Diabetes Technology & Therapeutics (publishedVersion, cc-by-nc)
- Europe PMC (PubMed Central) (publishedVersion, cc-by-nc)
- PubMed Central (publishedVersion, cc-by-nc)
- PubMed (publishedVersion)
- Funders
- Novo Nordisk
- Novo Nordisk Fonden (NNF15OC0015260)
- Topics
- Health Sciences › Medicine › Endocrinology, Diabetes and Metabolism › Diabetes Management and Research
- Health Sciences › Medicine › Endocrinology, Diabetes and Metabolism › Diabetes Management and Education
- Health Sciences › Medicine › Endocrinology, Diabetes and Metabolism › Diabetes Treatment and Management
- Keywords
- FreeStyle Libre, flash glucose monitoring, type 1 diabetes, continuous glucose monitoring, measurement accuracy, mean absolute relative difference, patient experience, self-monitoring of blood glucose, capillary blood glucose, adults with diabetes, hypoglycemia, hyperglycemia, treatment satisfaction, cost-effectiveness
- MeSH terms
- Adolescent, Adult, Aged, Blood Glucose, Diabetes Mellitus, Type 1, Female, Humans, Male, Middle Aged, Blood Glucose Self-Monitoring, Patient Satisfaction, Young Adult
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