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

Phase 4

Completed

• Conditions: Health Condition 1: null- Type I and II Diabetes Mellitus

• Registration Number: CTRI/2012/02/002404
• Lead Sponsor: Johnson and Johnson Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 100

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

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.

Study & Design

• Study Type: PMS
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Compare lay user and HCP OneTouch® SelectSimple� BGMS fingertip results to results obtained with a validated method and assess lay user acceptance of OneTouch® SelectSimple� BGMS <br/ ><br>Timepoints: Not applicable <br/ ><br>Timepoint: not applicable

Secondary Outcome Measures

Name	Time	Method
ot applicable <br/ ><br>Timepoint: Not applicable <br/ ><br>