To evaluate performance of the EXIMOTM Blood Glucose Monitoring System.

EXIMOTM: A single center, non-randomized, post marketing study to evaluate performance of the EXIMOTM Blood Glucose Monitoring System as per ISO 15197:2013 performance criteria. - EXIMOTM - PMS

Status

Active, not recruiting

Phases

Phase 4

Study type

Observational

Source

CTRI

Registry ID

CTRI/2017/03/008007

Enrollment

1000

Registered

2017-03-03

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: 8- Other Procedures

Interventions

Intervention1: Eximo Glucometer: To evaluate the performance of Eximo Blood Glucose Monitoring system.The blood is applied to the end tip of the test strip, it is automatically absorbed into the react

Eligibility

Inclusion criteria

Inclusion criteria: 1.Subject is able to speak, read and understand Informed Consent document. 2.Male and female of 18 years of age or older. 3.Subject is willing and able to complete study procedures

Exclusion criteria

Exclusion criteria: 1.Haemophilia, bleeding disorder, or clotting problems. 2.Subject is unable to speak, read and understand Informed Consent document. 3.Blood Borne infections like hepatitis or HIV or infections such as tuberculosis or skin disorders at the puncture site. 4.Pregnancy.

Design outcomes

Primary

Measure	Time frame
To evaluate the performance of the blood glucose level results obtained from fingertip using the EXIMOTM blood glucose monitoring system compared to laboratory glucose method (Cobas Integra 400 plus, Roche) as well as to evaluate the usability of the EximoTM blood glucose monitoring system by laypersons using only device labeling.Timepoint: After blood tests results from both the machines is obtained.	—

Measure

Time frame

To evaluate the performance of the blood glucose level results obtained from fingertip using the EXIMOTM blood glucose monitoring system compared to laboratory glucose method (Cobas Integra 400 plus, Roche) as well as to evaluate the usability of the EximoTM blood glucose monitoring system by laypersons using only device labeling.Timepoint: After blood tests results from both the machines is obtained.

—

Secondary

Measure	Time frame
NilTimepoint: Nil	—

Countries

India

Contacts

Public ContactDr Ashok Thakkar

Bombay Maternity & Surgical hospital

yourgynehelpline@gmail.com0261-2253954

Outcome results

None listed

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