Clinical trial NCT04340648: Measurement Algorithm Control, Optimization, and Performance Evaluation of the Vital USA GlucoseDetect
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes Mellitus
Lead sponsor: Sciema UG
Sponsor class: OTHER
First posted: 2020-04-09
Enrollment: 32
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: patients are divided in two groups and both groups are enrolled sequential and undergo the same procedures
Primary purpose: DIAGNOSTIC

Brief 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.

Eligibility criteria: Inclusion Criteria:

* Type 1 or Type 2 diabetic or healthy subject (50 % from each)
* Subjects who are able to complete informed consent form (by him/herself or by his/her guardian);
* 18 years old and above;
* Anatomically suitable finger in discretion of the investigator

Exclusion Criteria:

* Does not meet inclusion criteria;
* Any conditions that may hamper good visual contact between the finger or wrist and sensor, such as raised birthmarks, scars, tattoos;
* Pregnancy;
* Nursing mothers;
* Any skin scratch(es), damage, over dry, long nails on the measured finger;
* Unsuitable finger with the device might be excluded if recognized during the trial;
* Medication containing nitrates

Primary outcomes:
measure: Performance and accuracy in glucose monitoring and other parameters
timeFrame: 210 min
measure: Performance and accuracy in pO2 monitoring
timeFrame: 210 min
measure: Performance and accuracy in pulse monitoring
timeFrame: 210 min
Secondary outcomes:
Other outcomes:
Locations:
city: Mainz
country: Germany
facility: Pfützner Science & Health Institute GmbH
state: Rhineland-Palatinate
Study officials:
affiliation: Pfützner Science & Health Institute GmbH
name: Andreas Pfützner, Prof. Dr. Dr.
role: PRINCIPAL_INVESTIGATOR
References: