A study to compare the accuracy of blood sugar readings by OneTouchÂ® SelectSimpleâ?¢ glucometer performed by patient, health care professional with the results obtained with a validated method (YSI 2300 STAT PLUS glucose analyzer

OneTouchÂ® SelectSimpleâ?¢ BGMS Clinical Evaluation Protocol: Comparison to a Validated Method and Marketing Claims Study

Status

Active, not recruiting

Phases

Phase 4

Study type

Observational

Source

CTRI

Registry ID

CTRI/2012/02/002404

Enrollment

100

Registered

2012-02-03

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: null- Type I and II Diabetes Mellitus

Interventions

Intervention1: OneTouchÂ® SelectSimpleâ?¢ Blood Glucose Monitoring by patients and health care professional: OneTouchÂ® SelectSimpleâ?¢ Blood Glucose Monitoring System (BGMS) combines the OneTouchÂ® S

Eligibility

Inclusion criteria

Inclusion criteria: 1. Age â?? Each Subject will be at least 18 years old. 2. Informed Consent â?? Each potential Subject must read and sign an Independent Ethics Committee (IEC) approved Information Sheet and Informed Consent Form 3. Personal Health Information (PHI) â?? The Subject (enrollee) agrees to provide demographic and medical history information and allow access to medical records when necessary. 4. Diabetes Diagnosis â?? The Subject has a current diagnosis of type 1 or type 2 diabetes. 5. Self-Monitoring â?? The Subject is currently performing self-monitoring of blood glucose (SMBG) using a non-OneTouch meter and the subject has been self-testing with the non-OneTouch meter without assistance for at least 1 month. 6. Language â?? The Subject reads and understands English. 7. Study Activities â?? The Subject agrees to complete all aspects of the study, including fingertip self-lancings.

Exclusion criteria

Exclusion criteria: 1. Conflict of Interest â?? The Subject is currently working for, has previously worked for, or has an immediate family member working for a company that manufactures or markets blood glucose monitoring products. 2. Technical Expertise â?? The Subject has laboratory training or phlebotomy experience (medical technologist, phlebotomist, laboratory technician, laboratory assistant performing laboratory tests, etc.) 3. Pregnancy â??The Subject is pregnant.

Design outcomes

Primary

Measure	Time frame
Compare lay user and HCP OneTouchÂ® SelectSimpleâ?¢ BGMS fingertip results to results obtained with a validated method and assess lay user acceptance of OneTouchÂ® SelectSimpleâ?¢ BGMS Timepoints: Not applicable Timepoint: not applicable	—

Secondary

Measure	Time frame
Not applicable Timepoint: Not applicable	—

Countries

India

Contacts

Public ContactAnil Nayak

Johnson and Johnson Ltd

adesai8@its.jnj.com

Outcome results

None listed

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