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Performance of a new real-time continuous glucose monitoring system: a validation study of the Medtrum TouchCare Nano 14 CGM System

Withdrawn
Conditions
Diabetes Mellitus
10018424
Registration Number
NL-OMON50146
Lead Sponsor
Isala Klinieken
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Withdrawn
Sex
Not specified
Target Recruitment
30
Inclusion Criteria

Participants will be selected from patients seen at the diabetes outpatient
clinics of the Isala hospital, Zwolle and the University Medical Center in
Groningen

Exclusion Criteria

Main exclusion criteria are the inability to understand the Dutch language and
the presence of a severe or unstable medical condition.

Study & Design

Study Type
Observational invasive
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
<p>The accuracy of both TouchCare Nano 14 CGMs compared to StatStrip Xpress®<br /><br>during the 14-day study period.</p><br>
Secondary Outcome Measures
NameTimeMethod
<p>The accuracy of both TouchCare Nano 14 CGMs compared to the FGM-FSL1-CGM and<br /><br>the StatStrip Xpress readings during the 14-day study period.</p><br>
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