No registrations found.
ID
Source
Health condition
Diabetes Mellitus, Glucose monitoring
Sponsors and support
Dr. Van Heesweg 2, 8025 AB Zwolle
Postbus 10400, 8000 GK Zwolle
Intervention
Outcome measures
Primary outcome
Primary endpoints
A: Parkes Error grids (ISO15197:2013) as described by Parkes.
.
Secondary outcome
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
Background summary
In subjects with diabetes, adequate to good metabolic control is necessary for a variety of reasons. In active subjects who perform exercising and sports activities, adequate glucose control, including prevention of hypo- and hyperglycemias, would allow good performance. This will even more so the case when the sports activity is going to the strenuous and extreme. The aim of this study is to determine the performance (compared to capillary measurements) of two CGMs (flash and continous) during and after strenuous and extreme exercise conditions in subjects with diabetes
Study objective
Bij personen met diabetes is een redelijk tot goede metabole controle om verschillende redenen noodzakelijk. Bij actieve proefpersonen die lichaamsbeweging en sportactiviteiten uitoefenen, zou adequate glucoseregulatie, inclusief preventie van hypo- en hyperglycemieën, goede prestaties mogelijk maken. Dit zal des te meer het geval zijn wanneer de sportactiviteit tot het inspannende en extreme gaat. Bruikbaarheid van de Eversense versus de Free Style Libre Flash Monitor in (vóór en na) zware en extreme inspanningsomstandigheden bij personen met diabetes wordt getest.
Study design
start of study 01-08-2018
Strenuous exercise 14/22 - 09-2018
end of study 30-11-2015
Intervention
Wearing two CGMs (Flash and Continous) to assess reliability and accuracy of glucose measurements. Specifically: comparison of two devices with capillary measurements.
Universitair Medisch Centrum Groningen <br>
Hanzeplein 1, 9713 GZ Groningen <br>
Afdeling Interne Geneeskunde <br>
Hoofd Diabetes Kenniscentrum Zwolle <br>
Postbus 10400, 8000 GK <br>
Dokter van Heesweg 2, 8025 AB Zwolle
H.J.G. Bilo
Zwolle
The Netherlands
038-4242518
h.j.g.bilo@isala.nl
Universitair Medisch Centrum Groningen <br>
Hanzeplein 1, 9713 GZ Groningen <br>
Afdeling Interne Geneeskunde <br>
Hoofd Diabetes Kenniscentrum Zwolle <br>
Postbus 10400, 8000 GK <br>
Dokter van Heesweg 2, 8025 AB Zwolle
H.J.G. Bilo
Zwolle
The Netherlands
038-4242518
h.j.g.bilo@isala.nl
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.
Design
Recruitment
Followed up by the following (possibly more current) registration
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL7133 |
| NTR-old | NTR7330 |
| CCMO | NL66388.075.18 |
| OMON | NL-OMON45979 |