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Bruikbaarheid van de Eversense versus de Free Style Libre Flash Monitor in (tijdens en na) zware en extreme inspanningsomstandigheden bij personen met diabetes

Performance of the Eversense vs the Free Style Libre Flash Monitor in (during and after) strenuous and extreme exercise conditions in subjects with diabetes

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON27357
Enrollment
25
Registered
2018-06-12
Start date
2018-08-01
Completion date
Unknown
Last updated
2024-06-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetes Mellitus, Glucose monitoring

Interventions

Wearing two CGMs (Flash and Continous) to assess reliability and accuracy of glucose measurements. Specifically: comparison of two devices with capillary measurements.

Sponsors

Isala, Zwolle Dr. Van Heesweg 2, 8025 AB Zwolle Postbus 10400, 8000 GK Zwolle
Lead Sponsor

Eligibility

Inclusion criteria

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

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.

Design outcomes

Secondary

MeasureTime frame
A: Time in hypoglycemia comparing FLFM and GCCGM. B: Time in normo- and in hyperglycemia, again comparing both devices. C: satisfaction with and usability of the devices in the 6-day challenge period. D: MAD and MARD comparing FLFM, GCCGM and capillary measurements

Primary

MeasureTime frame
Primary endpoints A: Parkes Error grids (ISO15197:2013) as described by Parkes. .

Contacts

Public ContactH.J.G. Bilo

internist Universitair Medisch Centrum Groningen Hanzeplein 1, 9713 GZ Groningen Afdeling Interne Geneeskunde Hoofd Diabetes Kenniscentrum Zwolle Postbus 10400, 8000 GK Dokter van Heesweg 2, 8025 AB Zwolle

h.j.g.bilo@isala.nl038-4242518

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)