Performance of the Freestyle Libre Version 2 isCGM in daily practice in Elderly

• Conditions: Diabetes mellitus; 10018424

• Registration Number: NL-OMON56777
• Lead Sponsor: niversitair Medisch Centrum Groningen

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 18 June 2024

Recruitment & Eligibility

• Status: Pending
• Sex: Not specified
• Target Recruitment: 26

Inclusion Criteria

- Age >=70 years at time of inclusion
- Diabetes, type 1 or type 2
- Ability to provide oral and written informed consent

Exclusion Criteria

- A history of allergies towards patch substances/adhesive;
- The inability to understand the Dutch language;
- Oral or injected steroid use within the past 3 months
- Uncontrolled thyroid disease or hypertension
- Poor visual acuity
- Inability or unwillingness to meet the protocol requirements, such as being
incapacitated
- Any severe or uncontrolled medical or psychological condition which, in the
opinion of the investigator, would compromise the ability to meet protocol
requirements.

Study & Design

• Study Type: Observational invasive
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Primary outcome is the accuracy of the FSL-v2 compared to Contour blue<br /><br>capillary measurement results during the 14-day study period. </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Secondary outcomes are (i) the accuracy of the FSL during the standardized oral<br /><br>glucose load test and (ii) the usability and satisfaction with the FSL.<br /><br>Accuracy will be analysed as according to the guidelines for Integrated<br /><br>Continuous Glucose Monitoring Approvals (Class II-510(K), (Parkes) error grid-,<br /><br>bias (including MARD), correlation, stability and Bland-Altman analysis.</p><br>