To establish the performance of the TouchCare Nano 14 CGM system among persons with DM.
ID
Source
Brief title
Condition
- Glucose metabolism disorders (incl diabetes mellitus)
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
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 outcome
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.
Background summary
The Medtrum TouchCare Nano 14 CGM System is a novel CGM system for interstitial
glucose measurements. It uses a small, soft and transcutaneous glucose oxidase*
based electrochemical glucose sensor (MD3568) to detect glucose levels in the
interstitial fluid every 2 min; this sensor provides information over a period
of maximal 14 days. As accurate glucose measurements are of utmost importance
for persons with type 1 diabetes mellitus (T1DM), information concerning the
accuracy of this device is of relevance. Since the testing up to now has been
performed with the TouchCare Nano Sensor inserted in the upper arm, further
testing on performance and accuracy when inserted in another part of the body
is also needed.
Study objective
To establish the performance of the TouchCare Nano 14 CGM system among persons
with DM.
Study design
Prospective non-randomized cohort study assessing the performance of the
TouchCare Nano 14 CGM as compared to capillary measurements using Contour Plus
Blue monitoring system (Ascencia Diabetes Care) (traceable to the gold standard
glucose Isotope Dilution-Gas Chromatography-Mass Spectrometry (ID-GCMS) and
controlled with National Institute of Standards and Technology (NIST) and a
commonly used CGM (CGM) device ( FreeStyle Libre 2). Measurements will be
performed during a 14-day study period.
Study burden and risks
Participants will be asked to wear three glucose monitoring devices at once and
to measure their capillary blood glucose levels at regular intervals (at least
4, but preferably 7 times daily).
Dr. van Heesweg 2
Zwolle 8025AB
NL
Dr. van Heesweg 2
Zwolle 8025AB
NL
Listed location countries
Age
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
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
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Other (possibly less up-to-date) registrations in this register
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In other registers
| Register | ID |
|---|---|
| CCMO | NL84439.075.23 |