Non-invasive glucose measurement with Raman technology. Calibration of newly developed devices in subjects with type 1 and type 2 diabetes – Glucobrunn study (RSP-09)

Aim of the study

‍Calibration model establishment and performance assessment for the Prototype 0.3 device, with focus on robustness across in-clinic and outpatient conditions.

Study description

At Site 1, 30 participants with type 1 and type 2 diabetes attended in-clinic measurement sessions, during which capillary blood glucose measurements were performed alongside measurements using the Prototype 0.3 Raman spectroscopy device.  

At Site 2, 15 participants with type 1 diabetes were followed during both in-clinic and out-patient periods, covering a wide range of glucose excursions over a total study duration of up to 28 days. Each measurement session included paired reference measurements and device measurements, consisting of capillary blood glucose sampling, interstitial CGM data, and two consecutive measurements using the spectroscopy device.

‍

Conclusions

‍The Prototype 0.3 device successfully followed glucose patterns across both in-clinic and outpatient conditions, particularly during periods of larger glucose fluctuations.

‍

Study registration

‍For more information, see the study registration on ClinicalTrials.gov (NCT03781232).

‍