Individual Study / Fokkert et al.; BMJ Open Diabetes Res Care. 2017

Performance of the FreeStyle Libre Flash Glucose Monitoring System in Patients With Type 1 and 2 Diabetes Mellitus

Performance of the FreeStyle Libre Flash Glucose Monitoring System in Patients With Type 1 and 2 Diabetes Mellitus

Initiatives -
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
  • Individuals

Number of participants

Number of participants
20
Number of participants with biosamples

Access

Availability of data and biosamples

Data
Biosamples
Other

Timeline

Population

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
18
Maximum age
75
Newborns
Twins
Countries
  • Netherlands
Ethnic Origin
Health Status
  • 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
2015-08
End Date
2015-09
Data sources
  • Smart sensors
    • Glucose monitors