Performance of the FreeStyle Libre Flash Glucose Monitoring System in Patients With Type 1 and 2 Diabetes Mellitus
Initiatives
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To evaluate the performance of the FreeStyle Libre Flash continuous glucose monitoring (FSL-CGM) system against established central laboratory methods.
Note: All published information has been collected from the article referenced in the Marker Paper box below. Therefore, there may be variations with more advanced versions of the study.
- Start Year
- 2015
- End Year
- 2015
- Funding
- This study was supported by an unconditional grant of the StichtingAchmea Gezondheidszorg (SAG).
Design
- Study design
- Clinical trial cohort
Marker Paper
Fokkert MJ, van Dijk PR, Edens MA, et al. Performance of the FreeStyle Libre Flash glucose monitoring system in patients with type 1 and 2 diabetes mellitus. BMJ Open Diabetes Res Care. 2017;5(1):e000320. Published 2017 Feb 17. doi:10.1136/bmjdrc-2016-000320
PUBMED 28243449
Recruitment
- Sources of Recruitment
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- Individuals
Number of participants
- Number of participants
- 20
- Number of participants with biosamples
Access
Availability of data and biosamples
| Data | |
| Biosamples | |
| Other |
Timeline
Persons with T1DM, T2DM
Persons with T1DM, T2DM, and persons without DM between 18 and 75 years of age who were able to undergo the requested study procedures were eligiblefor study participation.
Selection Criteria
- Minimum age
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18
- Maximum age
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75
- Newborns
- Twins
- Countries
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- Netherlands
- Ethnic Origin
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- Health Status
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- Persons with T1DM, T2DM
- Other criteria
- Main exclusion criteria was the presence of a severe or unstable medical condition.
Recruitment
- Sources of recruitment
-
- General population
Number of participants
- Number of participants
- 20
- Number of participants with biosamples
Data Collection Event
FSL-CGM sensor measurements (inserted in arm and abdomen) were compared with capillary blood glucose results analyzed with StatStrip as semigold standard. The glucose response after a standardized oral glucose load was measured by FSL-CGM and capillary samples analyzed by perchloric acid hexokinase (PCA-HK) method, StatStrip and FSL test strip (FSLC), and a commonly used CGM system (iPro2).
- Start Date
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2015-08
- End Date
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2015-09
- Data sources
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Smart sensors
- Glucose monitors
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Smart sensors