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Clinical study to test and confirm the successful application of the technology in measuring Blood glucose without taking blood sample

Clinical Evaluation of Svasth Wearable Non-Invasive Device.

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
CTRI
Registry ID
CTRI/2020/10/028454
Enrollment
6400
Registered
2020-10-16
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: E088- Diabetes mellitus due to underlying condition with unspecified complications Health Condition 2: E118- Type 2 diabetes mellitus with unspecified complications

Interventions

Control Intervention1: NIL: Not applicable Control Intervention2: NIL: Not applicable

Sponsors

Miisky Technovation Pvt Ltd
Lead Sponsor

Eligibility

Inclusion criteria

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

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.

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
To calibrate the device to predict SpO2, Hear Rate, Body Temprature & Hemoglobin results comparable to laboratory standards.Timepoint: 12 weeks.

Countries

India

Contacts

Public ContactG Jagannathan

White Lotus Healthcare Clinic

satish18babu@gmail.com9731533636

Outcome results

None listed

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