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ID
Source
Brief title
Health condition
Diabetes Mellitus
Sponsors and support
Intervention
Outcome measures
Primary outcome
The performance of the M-CGM compared to Nova capillary test strip during the 14-day study period.
Secondary outcome
The performance of the M-CGM compared to concomitantly used own FGM or rt-CGM device
Background summary
In subjects with diabetes, adequate to good metabolic control is necessary for a variety of reasons. Diabetes therapy requires intensive self-management from patients with diabetes type 1 including at least four times measurement of glucose concentrations and injection of the blood glucose lowering hormone insulin. If used appropriately, with rt-CGM the user often only needs to calibrate the sensor at some time points daily and being able to act and react on alarms preset at certain cut-off points. The aim of this study is to determine the performance (compared to capillary measurements) of a CGM during daily life in subjects with diabetes
Study objective
N/A
Study design
Start study: 2-11-2020
Wearing the GlucoMen® Day CGM for 14 days: 10-11-2020 through 10-12-2020
End of study: 30-1-2020
Intervention
Wearing a CGM to assess reliability and accuracy of glucose measurements. Specifically: comparison of the device with capillary measurements.
Inclusion criteria
Subjects with type 1 diabetes mellitus, using insulin either by MDI or CSII.
Ability to provide oral and written informed consent
Exclusion criteria
Main exclusion criteria are the inability to understand the Dutch language and the presence of a severe or unstable medical condition.
Design
Recruitment
IPD sharing statement
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL9039 |
| CCMO | NL.74404.075.20 |