Status:
COMPLETED
Measurement Algorithm Control and Optimization With Subsequent Performance Evaluation of Sanmina Non-invasive Biosensors During a Standardized Meal Test in Patients With Diabetes Mellitus Type 1 and Type 2
Lead Sponsor:
Sciema UG
Collaborating Sponsors:
Sanmina
Conditions:
Diabetes Mellitus
Eligibility:
All Genders
18-100 years
Phase:
NA
Brief Summary
Measurement algorithm control and optimization with subsequent performance evaluation of Sanmina biosensors in monitoring of glucose, heart rate (HR), and SpO2 in patients with type 1 and type 2 diabe...
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 12 patients each. In the th...
Eligibility Criteria
Inclusion
- Type 1 or Type 2 diabetic subjects or healthy probands
- 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 :
March 25 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2020
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT04379427
Start Date
March 25 2019
End Date
April 1 2020
Last Update
May 7 2020
Active Locations (1)
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1
Pfuetzner Science & Health Institute GmbH
Mainz, Rhineland-Palatinate, Germany, 55128