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

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

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON53212

Enrollment

Registered

2023-08-14

Start date

2024-08-13

Completion date

Unknown

Last updated

2024-11-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetes Mellitus

Interventions

None listed

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: Presence of type 1 DM age between 18 and 75 years old

Exclusion criteria

Exclusion criteria: - The inability to understand the Dutch language; - Poor visual acuity - Inability or unwillingness to meet the protocol requirements

Design outcomes

Primary

Measure	Time frame
Primary outcome is the accuracy of the TouchCare Nano 14 CGM compared to Contour Plus Bluestrip capillary measurement results during the 14-day study period.	—

Secondary

Measure	Time frame
Secondary outcomes include (i) accuracy of the TouchCare Nano 14 CGM compared to the FreeStyle Libre 2 CGM during the 14-day study period and (ii) usability and satisfaction with the TouchCare Nano 14 CGM . Accuracy will (primarily) be analysed as according to the guidelines for Integrated Continuous Glucose Monitoring Approvals (Class II-510(K), (Parkes) error grid-, bias (including MARD), correlation, stability and Bland-Altman analysis.	—

Measure

Time frame

Secondary outcomes include (i) accuracy of the TouchCare Nano 14 CGM compared to the FreeStyle Libre 2 CGM during the 14-day study period and (ii) usability and satisfaction with the TouchCare Nano 14 CGM . Accuracy will (primarily) be analysed as according to the guidelines for Integrated Continuous Glucose Monitoring Approvals (Class II-510(K), (Parkes) error grid-, bias (including MARD), correlation, stability and Bland-Altman analysis.

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Countries

Netherlands

Outcome results