Performance characteristics of non-invasive glucose monitoring device prototypes (RSP-16)

Aim of the study

‍Evaluation and comparison of investigational non-invasive glucose monitoring prototypes and assessment of their safe use in extended home-based monitoring.  

Evaluation of the performance and safety assessment of the P0.2 investigational non-invasive glucose monitoring prototype during extended home use.

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Study description

‍The 24 participants used the device either during short, intensive measurement days (5 days for 10 hours a day) or at home over several months to assess both short-term performance and long-term stability. Device measurements were compared with standard glucose measurements, all collected while participants followed their normal daily routines.

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Conclusions

‍The P0.2 prototype showed stable performance and no safety concerns during extended home use, supporting its suitability for longer-term outpatient monitoring.

Study registration

‍For more information, see the study registration on ClinicalTrials.gov (NCT04021251).