Skip to content

Testing of BOLT Device in measuring Blood Glucose, Total Cholesterol & Blood Hemoglobin Levels as per applicable ISO Standards in humans

Validation of B.O.L.T Body Life Tracker Device reports in measuring Blood Glucose, Total Cholesterol & Blood Hemoglobin Levels as per applicable ISO Standards.

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
CTRI
Registry ID
CTRI/2018/10/016119
Enrollment
150
Registered
2018-10-23
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: R730- Abnormal glucose Health Condition 2: R718- Other abnormality of red blood cells Health Condition 3: R098- Other specified symptoms and signsinvolving the circulatory and respiratory systems Health Condition 4: R098- Other specified symptoms and signsinvolving the circulatory and respiratory systems

Interventions

Control Intervention1: Standard laboratory test: The test reports of test device will be compared with standard laboratory reports. All subject has to undergo test with both test device and the standa

Sponsors

American Megatrends India Pvt Ltd
Lead Sponsor

Eligibility

Inclusion criteria

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

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

Design outcomes

Primary

MeasureTime frame
Quantitative comparison between the test device (B.O.L.T) and the reference device (standard devices/procedures) for the following parameters 1. Blood Glucose 2. Total Cholesterol 3. Blood Haemoglobin Timepoint: Same Day

Secondary

MeasureTime frame
Ease of use of test device will be determined as per the list of questionnaires.Timepoint: same day

Countries

India

Contacts

Public ContactSubham Dutta

American Megatrends India Pvt. Ltd.

divyak@amiindia.co.in

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026