Diabetes Mellitus Clinical Trial
Official title:
Measurement Algorithm Control and Optimization With Subsequent Performance Evaluation of the Vital USA GlucoseDetect™ During a Standardized Meal Test in Patients With Diabetes Mellitus Type 1 and Type 2
Measurement Algorithm Control and Optimization with Subsequent Performance Evaluation of the Vital USA GlucoseDetect™ During a Standardized Meal Test in Patients with Diabetes mellitus Type 1 and Type 2
This study is a combined, open label, prospective, comparative single-center study.
The study is separated in 3 consecutive study parts. The first 2 study parts include 16
patients each. In the third study part 16 additional patients will be enrolled. Study part 1
and 2 will be used for optimization and validation of the measurement algorithms of the Vital
USA biosensor. During the third study part with enrolment of 16 additional patients, the
precision and accuracy of the final Vital USA biosensor algorithm will be demonstrated. The
visit schedule for all participants of all 3 study parts will be exactly the same. In all
groups of participants, the Vital USA non-invasive monitoring biosensor will be individually
introduced and assigned. During the experimental study visit, a standardized meal will be
given to the participants. Before and after the standardized meal, glucose, heart rate, and
pO2 will be measured using the Vital USA monitoring biosensor at time-points -30, 0, 15, 30,
45, 60, 75, 90, 120, 150 and 180 min. The glucose measurements will be compared to capillary
blood glucose measurements by YSI Stat 2300. Parallel measurements of the heart rate and the
pO2 using a patient monitor will be compared to the device readings.
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