Clinical study to test and confirm the successful application of the technology in measuring Blood glucose without taking blood sample
Not Applicable
- Conditions
- Health Condition 1: E088- Diabetes mellitus due to underlying condition with unspecified complicationsHealth Condition 2: E118- Type 2 diabetes mellitus with unspecified complications
- Registration Number
- CTRI/2020/10/028454
- Lead Sponsor
- Miisky Technovation Pvt Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
Inclusion Criteria
1. Male, 18 to 65 years of age (both
inclusive), suffering from Type-1 & Type-2
Diabetes Mellitus.
2. Non-pregnant female subjects, 18 to 65 years
of age (both inclusive), suffering from
Type-1 & Type-2 Diabetes Mellitus.
3. Male & female meeting the above criteria &
willing to sign Informed Consent form
Exclusion Criteria
1. Subjects who do not meet any of the one or
more inclusion criteria
2. Subjects who meet the criteria but fail to
sign Informed consent form.
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To calibrate the device to predict results comparable to Venous blood results and Continuous Glucose monitoring device.Timepoint: Every 3 month for 1 year.
- Secondary Outcome Measures
Name Time Method To calibrate the device to predict SpO2, Hear Rate, Body Temprature & Hemoglobin results comparable to laboratory standards.Timepoint: 12 weeks.