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Masked performance check of the Abbott FreeStyle Libre Flash Glucose Monitoring System

Masked performance check of the Abbott FreeStyle Libre Flash Glucose Monitoring System: an interventional trial

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN12543702
Enrollment
108
Registered
2015-08-17
Start date
2015-07-20
Completion date
Unknown
Last updated
2024-01-08

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

Interventions as on 08/02/2017: 1. Participants will wear up to 3 Masked FreeStyle Libre Glucose Monitoring Sensor for up to 14 days. Participants have an option to experience the use ofan unmasked Fr

Sponsors

Abbott Diabetes Care Ltd
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Aged 18 years or over 2. Have type 1 or type 2 diabetes 3. Be self-testing their blood glucose levels at least twice per day 4. Be able to follow the instructions provided to him/her by the study site and perform all study tasks as specified by the protocol, in the investigator’s opinion 5. Be available for all study visits 6. Be willing to provide written informed consent

Exclusion criteria

Exclusion criteria: 1. Participated in the same study event 2. Be a member of the study staff 3. Have a known allergy to medical grade adhesive 4. Be pregnant or planning to become pregnant within the study event duration 5. Have skin abnormality at the application sites 6. Have a pacemaker or any other neuro stimulators 7. Have concomitant medical condition which in the investigator’s opinion could interfere with the study or present a risk to the safety or welfare of the participant or study staff

Design outcomes

Primary

MeasureTime frame
Accuracy performance of the Abbott FreeStyle Libre Flash Glucose Monitoring System compared to capillary fingerstick blood glucose values (FreeStyle Optium blood glucose test strips) using the consensus error grid.

Secondary

MeasureTime frame
Precision within Sensor lot.

Countries

England, United Kingdom

Contacts

Public ContactPamela Reid
pamela.reid@abbott.com+44 1993 863024

Outcome results

None listed

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