Status:
COMPLETED
Measurement Algorithm Control, Optimization, and Performance Evaluation of the Vital USA GlucoseDetect
Lead Sponsor:
Sciema UG
Conditions:
Diabetes Mellitus
Eligibility:
All Genders
18-99 years
Phase:
NA
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...
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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
June 3 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 30 2019
Estimated Enrollment :
32 Patients enrolled
Trial Details
Trial ID
NCT04340648
Start Date
June 3 2019
End Date
November 30 2019
Last Update
April 9 2020
Active Locations (1)
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1
Pfützner Science & Health Institute GmbH
Mainz, Rhineland-Palatinate, Germany, 55128