Testing of BOLT Device in measuring Blood Glucose,Total Cholesterol & Blood Hemoglobin Levels as per applicable ISO Standards in humans
Not Applicable
Completed
- Conditions
- Health Condition 1: R730- Abnormal glucoseHealth Condition 2: R718- Other abnormality of red blood cellsHealth Condition 3: R098- Other specified symptoms and signsinvolving the circulatory and respiratory systemsHealth Condition 4: R098- Other specified symptoms and signsinvolving the circulatory and respiratory systems
- Registration Number
- CTRI/2018/10/016119
- Lead Sponsor
- American Megatrends India Pvt Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 0
Inclusion Criteria
1. Subject is willing to give written informed consent for participation in the study.
2. Male or Female, aged 18 years or above.
3. Subjects having one or more following medical history-
a) Diabetes (Type I & II)
b) Cholesterol
c) Anaemia
Exclusion Criteria
1. Geriatric subjects above 75 years of age
2. Mentally challenged subjects
3. Subjects with following blood disorders
a) Blood Cancer-
-Lymphoma
-Leukemia
-Myeloma
-Polycythemia
b) Clotting disorder-
-Von Willebrand disease
-Hemophilia
-Thrombocythemia
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Quantitative comparison between the test device (B.O.L.T) and the reference device (standard devices/procedures) for the following parameters <br/ ><br>1. Blood Glucose <br/ ><br>2. Total Cholesterol <br/ ><br>3. Blood Haemoglobin <br/ ><br> <br/ ><br>Timepoint: Same Day <br/ ><br> <br/ ><br>
- Secondary Outcome Measures
Name Time Method Ease of use of test device will be determined as per the list of questionnaires.Timepoint: same day