Performance of the Eversense vs the Free Style Libre Flash Monitor in (before, during and after) strenuous and extreme exercise conditions in subjects with diabetes
Phase 4
Completed
- Conditions
- 10018424diabetes
- Registration Number
- NL-OMON45979
- Lead Sponsor
- Diabetescentrum
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 10
Inclusion Criteria
Subjects with type 1 or type 2 diabetes mellitus, using insulin either by MDI or by CSII
Being fit enough to participate in the Bas van de Goor Foundation *we bike to change diabetes* challenge in September 2018. and willing to spend a week in resting conditions in the week after the challenge.
Willing to accept insertion and extraction of ECGM.
Written informed consent
Exclusion Criteria
Unable to understand the proposals in Dutch or Spanish
A condition likely to require magnetic resonance imaging for the duration of the study.
Study & Design
- Study Type
- Observational invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Parkes Error grids (ISO15197:2013)</p><br>
- Secondary Outcome Measures
Name Time Method <p>A: Time in hypoglycemia comparing FLFM and GCCGM.<br /><br>B: Time in normo- and in hyperglycemia, again comparing both devices.<br /><br>C: satisfaction with and usability of the devices in the 6-day challenge<br /><br>period.<br /><br>D: MAD and MARD comparing FLFM, GCCGM and capillary measurements </p><br>