Diabetes technology

Accuracy and Feasibility of a Novel Glucose/Lactate Continuous Multi-Analyte Sensing Platform in Humans

J Diabetes Sci TechnolPublished Diagnostic accuracy study

Authors' conclusion

Our initial data support safety and functionality of a novel glucose/lactate continuous multi-analyte sensor. Further sensor refinement will improve run-in performance and accuracy.

Study context

Population
Adults with diabetes; 7 female; mean age 43 years (SD 16); BMI 27 kg/m² (SD 5)11 analysed
Participants
16 adults
Comparison
Investigational glucose/lactate multi-analyte sensor vs Guardian 3 CGM, benchmarked against venous YSI
Outcome
Safety and function of the glucose/lactate multi-analyte sensor vs venous YSI glucose and lactate
Follow-up
Day 1 and day 4 of wear
Methodological detailsfirst-in-human, pilot, Meal-test followed by exercise challenge on day 1 and day 4 of wear
  • First-in-human
  • Pilot
  • Meal-test followed by exercise challenge on day 1 and day 4 of wear

Performance

As reported in the abstract

Glucose MARD vs YSI · overall

Glucose MARD vs YSI · overall

Median MARD

Further findings

Investigational glucose sensor mean absolute relative difference (MARD) by day

MARD day 4
13.9%
MARD day 1
15.2%
  • Improved on day 4

Lactate sensor readings within 20/20% and 40/40% of YSI

Within 20/20%
59.7%
Within 40/40%
83.1%

Original publication

Accuracy and Feasibility of a Novel Glucose/Lactate Continuous Multi-Analyte Sensing Platform in Humans. J Diabetes Sci Technol. Published 29 July 2024. doi:10.1177/19322968241266822

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