Trial Outcomes & Findings for Evaluation of the A1CNow+ Test Kit (NCT NCT00798486)

Results Overview

This outcome measure reports the number of A1c test results for which the percent difference (absolute value) between results from the subject meter and the laboratory method was less than or equal to 13.5%.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

110 participants

Primary outcome timeframe

One hour

Results posted on

2016-02-29

Participant Flow

Participant milestones

Participant milestones
Measure	Subjects With and Without Diabetes Subjects participating in this study included 93 who had diabetes and 17 who did not have diabetes.
Overall Study STARTED	110
Overall Study COMPLETED	110
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Evaluation of the A1CNow+ Test Kit

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Subjects With and Without Diabetes n=110 Participants Subjects participating in this study included 93 who had diabetes and 17 who did not have diabetes.
Age, Continuous	46 years n=5 Participants
Sex: Female, Male Female	40 Participants n=5 Participants
Sex: Female, Male Male	70 Participants n=5 Participants
Region of Enrollment United States	110 participants n=5 Participants

PRIMARY outcome

Timeframe: One hour

This outcome measure reports the number of A1c test results for which the percent difference (absolute value) between results from the subject meter and the laboratory method was less than or equal to 13.5%.

Outcome measures

Outcome measures
Measure	Subjects With and Without Diabetes n=110 Participants Subjects participating in this study included 93 who had diabetes and 17 who did not have diabetes.
Number of A1C Results Either Equal To Or Within +/- 13.5% of the Laboratory Method (ACCURACY) Subjects had DVD and Written Instructions (n=101)	94 number of A1c results
Number of A1C Results Either Equal To Or Within +/- 13.5% of the Laboratory Method (ACCURACY) Subjects had Written Instructions only (n=77)	71 number of A1c results

SECONDARY outcome

Timeframe: One hour

Population: Precision Coefficient of Variation (CV)was analyzed using meter results from subject data that had numeric values for duplicate A1c self-tests. Subject data was not used in this outcome measure analysis when there had been a protocol deviation or when one (or both) A1c self-tests resulted in an error code.

The average Coefficient of Variation (CV) was computed by calculating the square of the CV for each pair of A1c self-test results, averaging this square value over the number of subjects included in the analysis, and then taking the square root.

Outcome measures

Outcome measures
Measure	Subjects With and Without Diabetes n=74 Participants Subjects participating in this study included 93 who had diabetes and 17 who did not have diabetes.
Average Within Subject Coefficient of Variation CV (PRECISION)	4.57 average percentage CV

SECONDARY outcome

Timeframe: One hour

For the comprehension analysis, subjects were divided into 2 groups. One group (n=56 subjects) was given both written (Quick Reference Guide) and DVD instruction material. The other group (n=54 subjects) was given only written instruction material. First time failure (FTF) was defined as: * The subject could not use the product without HCP assistance. * The subject could not complete the test. User error rendered one or more parts unusable. * The subject completed the test after one or more mistakes; the result was an error code instead of a numerical value.

Outcome measures

Outcome measures
Measure	Subjects With and Without Diabetes n=110 Participants Subjects participating in this study included 93 who had diabetes and 17 who did not have diabetes.
Percentage of Subjects Who Experienced First Time Failures (FTF) During Testing Subjects had DVD and Written Instructions	11 percentage of subjects
Percentage of Subjects Who Experienced First Time Failures (FTF) During Testing Subjects had Written Instructions Only	40 percentage of subjects

SECONDARY outcome

Timeframe: One hour

Subjects rated features of the A1C Test Kit, including 'Overall Testing Experience'. The rating scale was 4 (Excellent) to 1 (Poor).

Outcome measures

Outcome measures
Measure	Subjects With and Without Diabetes n=110 Participants Subjects participating in this study included 93 who had diabetes and 17 who did not have diabetes.
Number of Participants Who Provided These Ratings For Overall Testing Experience With A1C Test Kit 4 - Excellent	65 number of participants
Number of Participants Who Provided These Ratings For Overall Testing Experience With A1C Test Kit 3 - Very Good	38 number of participants
Number of Participants Who Provided These Ratings For Overall Testing Experience With A1C Test Kit 2 - Good	7 number of participants
Number of Participants Who Provided These Ratings For Overall Testing Experience With A1C Test Kit 1 - Poor	0 number of participants

Adverse Events

Subjects With and Without Diabetes

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Senior Clinical Research Scientist

Ascensia Diabetes Care

Phone: 574-257-3040

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: LTE60