Bruikbaarheid van de Eversense versus de Free Style Libre Flash Monitor in (tijdens en na) zware en extreme inspanningsomstandigheden bij personen met diabetes
- Conditions
- Diabetes Mellitus, Glucose monitoring
- Registration Number
- NL-OMON27357
- Lead Sponsor
- Isala, ZwolleDr. Van Heesweg 2, 8025 AB ZwollePostbus 10400, 8000 GK Zwolle
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Other
- Sex
- Not specified
- Target Recruitment
- 25
Inclusion Criteria
25 Participants with DM type 1 and DM type 2 will be recruited by the researcher via the Bas van de Goor foundation. Being fit enough to participate in the Bas van de Goor Foundation we bike to change diabetes” challenge in September 2018
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
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Primary endpoints<br /><br>A: Parkes Error grids (ISO15197:2013) as described by Parkes.<br>.<br>
- Secondary Outcome Measures
Name Time Method 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 period. <br /><br>D: MAD and MARD comparing FLFM, GCCGM and capillary measurements <br>