Calibration of a noninvasive glucose measurement device and assessment of its performance in the hypoglycaemic range in patients with type 1 diabetes (RSP-17)

Aim of the study

‍Calibration model validation and analytical performance assessment for the P0.3 prototype, with focus on the hypoglycaemic range.

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Study description

‍Fifteen participants used the P0.3 prototype during routine homebased measurement days and during two inclinic sessions designed to safely induce controlled glucose changes, including hypoglycaemia. At home, they completed regular daily measurement sessions during normal routines. In the clinic, glucose levels were tightly controlled using a clamp setup, with frequent reference measurements from venous samples, YSI, and capillary testing. The combined data were used to build and evaluate calibration models across both everyday and controlled conditions.

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Conclusions

‍The study demonstrated predictive capability in everyday use and clarified performance limitations under intensive in-clinic conditions, particularly in the hypoglycaemic range.

Study registration: For more information, see the study registration on ClinicalTrials.gov (NCT04126759).  

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