Diabetes Mellitus
Conditions
Brief summary
The purpose of this clinical study is to optimize the measurement algorithm of the Vital USA VitalDetectTM in measuring the microcirculating blood flow. Further optimization and finally the demonstration of the performance of the VitalDetectTM non-invasive monitoring biosensor in monitoring glucose, and heart rate in patients with type 1 and type 2 diabetes and healthy participants, when operated according to the instructions for use.
Detailed description
The study procedures will be the same for all three groups during the single visit. In all groups of participants, the Vital USA VitalDetect™ will be individually introduced and assigned. During the experimental study visit, microcirculating blood flow (MBF), heart rate, and SpO2 will be measured using the Vital USA VitalDetect™ at 2 time points in between approx. 15 min. MBF will be measured in parallel by use of the LEA Medizintechnik O2C also using a finger on the same hand. The YSI glucose measurements will be employed to generate a robust algorithm for glucose measurements using the VitalDetect™. Parallel measurements of the heart rate and the SpO2 using a patient monitor (Edan iM8b) will be compared to the Vital USA VitalDetect™ device readings. Venous blood will be drawn from every subject to determine proinsulin, insulin and HbA1c values.
Interventions
DEVICEVitalDetect
measurement of microcirculating blood flow, SpO2 (mmHg or %), heart rate (beats/min)
Sponsors
Sciema UG
Study design
Allocation
NA
Intervention model
SEQUENTIAL
Primary purpose
OTHER
Masking
NONE
Intervention model description
3 groups with the same study procedures in sequential timely series.
Eligibility
Sex/Gender
ALL
Age
18 Years to 99 Years
Healthy volunteers
Yes
Inclusion criteria
* Type 1 or Type 2 diabetic or healthy subject (25 Type 1, 25 Type 2, 50 healthy subjects) * 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 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Accuracy of the Vital USA VitalDetectTM for assessment of microcirculation (in AU) | 30 minutes | Accuracy and performance of Vital USA VitalDetectTM for assessment of microcirculation (in AU) by measuring microcirculation using the VitalDetectTM in comparison to the LEA Medizintechnik O2C device. |
Countries
Germany
Outcome results
None listed