NCT04340648

Measurement Algorithm Control, Optimization, and Performance Evaluation of the Vital USA GlucoseDetect

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 32 (actual)
• Sponsor: Sciema UG · Academic / Other
• Sex: All
• Age: 18 Years – 99 Years
• Healthy volunteers: Accepted

Summary

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

Detailed description

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.

Conditions

• Diabetes Mellitus

Interventions

Type	Name	Description
DEVICE	Vital GlucoseDetect	11 time points for blood glucose measurements over 210 min including the ingestion of a standardized meal 30 min after the first blood glucose measurement.

Timeline

• Start date: 2019-06-03
• Primary completion: 2019-10-31
• Completion: 2019-11-30
• First posted: 2020-04-09
• Last updated: 2020-04-09

Locations

1 site across 1 country: Germany