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Performance review for FreeStyle Libre Glucose Monitoring Systems

Sensor accuracy performance review for FreeStyle Libre Glucose Monitoring Systems

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ISRCTN
Registry ID
ISRCTN83594795
Enrollment
18
Registered
2021-06-28
Start date
2021-05-01
Completion date
Unknown
Last updated
2021-07-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetes mellitus Nutritional, Metabolic, Endocrine Diabetes mellitus

Interventions

Participants will wear up to four FreeStyle Libre Sensors for up to 14 days. There is no follow-up period unless the participant experiences an unanticipated adverse device effect (UADE).

Sponsors

Abbott (United Kingdom)
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Aged 18 years or over 2. Has type 1 or type 2 diabetes or has not been diagnosed as having diabetes 3. Be willing and able to test their blood glucose levels at least four times a day

Exclusion criteria

Exclusion criteria: 1. Has another form of diabetes e.g. maturity-onset diabetes of the young (MODY) 2. Have a known (or suspected) allergy to medical grade adhesive 3. Have a skin abnormality at the application sites 4. Have a pacemaker or any other neurostimulators 5. Have concomitant medical condition which in the participant’s opinion could interfere with the study or present a risk to their safety or welfare, or that of the study team

Design outcomes

Primary

MeasureTime frame
Accuracy of the FreeStyle Libre Glucose Monitoring Systems compared to capillary fingerstick blood glucose values (FreeStyle Optium blood glucose test strips) using the consensus error grid at the end of the sensor wear period

Secondary

MeasureTime frame
There are no secondary outcome measures

Countries

United Kingdom

Contacts

Public ContactPamela Reid
ADC.Clinical.Affairs.UK@abbott.com+44 (0)1993 863024

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026