N/A
ID
Bron
Verkorte titel
Aandoening
Diabetes Mellitus
Ondersteuning
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
The performance of the M-CGM compared to Nova capillary test strip during the 14-day study period.
Achtergrond van het onderzoek
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
Doel van het onderzoek
N/A
Onderzoeksopzet
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
Onderzoeksproduct en/of interventie
Wearing a CGM to assess reliability and accuracy of glucose measurements. Specifically: comparison of the device with capillary measurements.
Algemeen / deelnemers
Wetenschappers
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
Subjects with type 1 diabetes mellitus, using insulin either by MDI or CSII.
Ability to provide oral and written informed consent
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
Main exclusion criteria are the inability to understand the Dutch language and the presence of a severe or unstable medical condition.
Opzet
Deelname
Voornemen beschikbaar stellen Individuele Patiënten Data (IPD)
Opgevolgd door onderstaande (mogelijk meer actuele) registratie
Geen registraties gevonden.
Andere (mogelijk minder actuele) registraties in dit register
Geen registraties gevonden.
In overige registers
| Register | ID |
|---|---|
| NTR-new | NL9039 |
| CCMO | NL.74404.075.20 |