Performance check and safety data collection of FreeStyle Libre Glucose Monitoring Systems

Not Applicable

• Conditions: Diabetes mellitus; Nutritional, Metabolic, Endocrine

• Registration Number: ISRCTN87654534
• Lead Sponsor: Abbott Diabetes Care Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2015-03-16
• Last Update Posted: 10 October 2022
• Study Completion: 2027-12-31

Recruitment & Eligibility

• Status: Ongoing
• Sex: All
• Target Recruitment: 3600

Inclusion Criteria

1. Aged 18 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

1. Participated in the same study event
2. Be a member of 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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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. For all primary and secondary outcomes, the data is generated during the Sensor wear period (up to 14 days) during which the participant measures their blood glucose (BG) at least 4 times a day with corresponding Sensor scans. The data recorded in the Reader will be uploaded at visit 2 (day 15) and subsequently transferred to Abbott Diabetes Care (ADC) for analysis. The primary outcome will be measured by calculating the proportion of paired Sensor and BG values within each zone of the Consensus Error Grid.

Secondary Outcome Measures

Name	Time	Method
<br> 1. Precision within Sensor lot estimated by calculating the coefficient of variation of Sensor slopes. Slopes will be calculated for each sensor by standard linear regression of Sensor Glucose vs. BG<br> 2. Relationship between HbA1c levels and glycaemic variability, determined from Sensor glucose values<br> For all primary and secondary outcomes, the data is generated during the Sensor wear period (up to 14 days) during which the participant measures their blood glucose (BG) at least 4 times a day with corresponding Sensor scans. The data recorded in the Reader will be uploaded at visit 2 (day 15) and subsequently transferred to Abbott Diabetes Care (ADC) for analysis<br>