Performance of a new real-time continuous glucose monitoring system: a validation study of the Medtrum TouchCare Nano 14 CGM System
Recruiting
- Conditions
- Diabetes Mellitus10018424
- Registration Number
- NL-OMON53212
- Lead Sponsor
- Isala Klinieken
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 23
Inclusion Criteria
Presence of type 1 DM
age between 18 and 75 years old
Exclusion Criteria
- The inability to understand the Dutch language;
- Poor visual acuity
- Inability or unwillingness to meet the protocol requirements
Study & Design
- Study Type
- Observational invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Primary outcome is the accuracy of the TouchCare Nano 14 CGM compared to<br /><br>Contour Plus Bluestrip capillary measurement results during the 14-day study<br /><br>period. </p><br>
- Secondary Outcome Measures
Name Time Method <p>Secondary outcomes include (i) accuracy of the TouchCare Nano 14 CGM compared<br /><br>to the FreeStyle Libre 2 CGM during the 14-day study period and (ii) usability<br /><br>and satisfaction with the TouchCare Nano 14 CGM . Accuracy will (primarily) be<br /><br>analysed as according to the guidelines for Integrated Continuous Glucose<br /><br>Monitoring Approvals (Class II-510(K), (Parkes) error grid-, bias (including<br /><br>MARD), correlation, stability and Bland-Altman analysis.</p><br>