Diabetes Mellitus Clinical Trial
Official title:
Measurement Algorithm Control and Optimization With Subsequent Performance Evaluation of the Vital USA GlucoseDetectâ„¢ During a Standardized Meal Test in Patients With Diabetes Mellitus Type 1 and Type 2
Verified date | April 2020 |
Source | Sciema UG |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Measurement Algorithm Control and Optimization with Subsequent Performance Evaluation of the Vital USA GlucoseDetectâ„¢ During a Standardized Meal Test in Patients with Diabetes mellitus Type 1 and Type 2
Status | Completed |
Enrollment | 32 |
Est. completion date | November 30, 2019 |
Est. primary completion date | October 31, 2019 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 99 Years |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
Germany | Pfützner Science & Health Institute GmbH | Mainz | Rhineland-Palatinate |
Lead Sponsor | Collaborator |
---|---|
Sciema UG |
Germany,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Performance and accuracy in glucose monitoring and other parameters | Performance and accuracy in monitoring glucose levels (in mg/dL) using the GlucoseDetect during a standardized meal experiment. Measurements (during the meal experiment) of the GlucoseDetectTM will be compared to the capillary blood glucose reference method YSI STAT 2300 (glucose in mg/dL). | 210 min | |
Primary | Performance and accuracy in pO2 monitoring | Performance and accuracy in monitoring pO2 levels (in mmHg) using the GlucoseDetect during a standardized meal experiment. Measurements (during the meal experiment) of the GlucoseDetectTM will be compared to a patient monitor (pO2 (in mmHg). | 210 min | |
Primary | Performance and accuracy in pulse monitoring | Performance and accuracy in monitoring the pulse (in beats/min) using the GlucoseDetect during a standardized meal experiment. Measurements (during the meal experiment) of the GlucoseDetectTM will be compared to a patient monitor (pulse (in beats/min). | 210 min |
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