NCT03730480

User Performance of the CONTOUR NEXT and CONTOUR TV3 Blood Glucose Monitoring System (BGMS)

Completed NA Results posted Last updated 18 January 2022

What this trial tests

NA trial testing Contour Next and Contour TV3 BGMS testing by subjects with and without Diabetes in Diabetes Mellitus in 372 participants. Completed in 31 October 2018.

Timeline

6 September 2018

Primary endpoint
31 October 2018

31 October 2018

Quick facts

Lead sponsor	Ascensia Diabetes Care
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	sequential
Masking	none
Primary purpose	supportive care
Enrollment	372
Start date	6 September 2018
Primary completion	31 October 2018
Estimated completion	31 October 2018
Sites	2 locations across United States

Drugs / interventions tested

• Contour Next and Contour TV3 BGMS testing by subjects with and without Diabetes

Conditions studied

• Diabetes Mellitus — all drugs for Diabetes Mellitus →

Sponsor

Ascensia Diabetes Care

Who can join

18 and older, any sex, with Diabetes Mellitus. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Fingerstick Contour Next BGMS and Contour TV3 Results Compared to the Reference Analyzer Primary · 1 day

Number of Participants with self fingerstick results from the Contour Next BGMS and Contour TV3 BGMS that are within 15% of results from the Reference Analyzer. Results from the two meter systems will not be compared to each other.

Contour Next Contour Next BGMS

Group	Value	95% CI
Contour Next and Contour TV3 -Subjects With and Without Diabetes	366

Contour TV3 BGMS

Group	Value	95% CI
Contour Next and Contour TV3 -Subjects With and Without Diabetes	360

Subjects' Responses to 8 Statements Regarding Experience With Contour Next BGMS and Contour TV3 BGMS Secondary · 1 day

A questionnaire was given to participants with 8 statements about the BGMS instructions for use and ease of use of the meter system. These statements were rated by subjects on a Likert Scale with ratings of 1=strongly disagree, 2=disagree, 3=neutral, 4=agree, 5=strongly agree. Participants reporting ratings greater than or equal to 3 are reported. The statements are: 1. I find it easy to do a fingerstick blood test with this meter. 2. The meter display is easy to see and read. 3. It was easy to understand my test results. 4. I like the overall meter design. 5. I find the meter easy to use. 6.

Contour Next: Responses greater than or equal to 3 for Statement 1

Group	Value	95% CI
Contour Next BGMS and Contour TV3 BGMS-Subjects With and Without Diabetes	371

Contour Next: Responses greater than or equal to 3 for Statement 2

Group	Value	95% CI
Contour Next BGMS and Contour TV3 BGMS-Subjects With and Without Diabetes	371

Contour Next: Responses greater than or equal to 3 for Statement 3

Group	Value	95% CI
Contour Next BGMS and Contour TV3 BGMS-Subjects With and Without Diabetes	370

Contour Next: Responses greater than or equal to 3 for Statement 4

Group	Value	95% CI
Contour Next BGMS and Contour TV3 BGMS-Subjects With and Without Diabetes	359

Contour Next: Responses greater than or equal to 3 for Statement 5

Group	Value	95% CI
Contour Next BGMS and Contour TV3 BGMS-Subjects With and Without Diabetes	371

Contour Next: Responses greater than or equal to 3 for Statement 6

Group	Value	95% CI
Contour Next BGMS and Contour TV3 BGMS-Subjects With and Without Diabetes	367

Contour Next: Responses greater than or equal to 3 for Statement 7

Group	Value	95% CI
Contour Next BGMS and Contour TV3 BGMS-Subjects With and Without Diabetes	368

Contour Next: Responses greater than or equal to 3 for Statement 8

Group	Value	95% CI
Contour Next BGMS and Contour TV3 BGMS-Subjects With and Without Diabetes	368

Adverse events — posted to ClinicalTrials.gov

Time frame: 1 day.. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Contour Next BGMS and Contour TV3 BGMS -Subjects With and Without Diabetes

Serious: 0/372 (0%)

Deaths: 0/372

Other adverse events (2 terms — click to expand)

Reaction	System	Contour Next BGMS and Cont…
Vasovagal Reaction	General disorders	—
Fainting	General disorders	—

Data from ClinicalTrials.gov NCT03730480 adverse events section.

Sponsor's own description

This study will collect lay user ("subjects") and healthcare professional information on the performance of two different blood glucose monitors, the CONTOUR NEXT and the CONTOUR TV3, in people with and without diabetes. Each subject will use both meters, at different times and in different order, using a fingerstick(s) to collect meter samples. Meter results will be compared to standardized test system to assess the accuracy of the meters' results. Additionally, a blood sample will be drawn from the subject's arm by a trained healthcare professional for testing on both BGMS. Subjects will also be asked to complete a questionnaire to rate their experience using the meters and to evaluate the meter's Instructions for Use. After all testing and the first questionnaire have been completed, the study staff will demonstrate only to subjects with diabetes several features of the meters that would not necessarily be experienced during the meter testing. These subjects will then answer questions about the features in a second questionnaire.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.