Trial Outcomes & Findings for Performance Evaluation of Blood Glucose Monitoring System Using ISO Study Design (NCT NCT01575080)

Last Updated: 2016-02-29

Results Overview

Untrained subjects with diabetes self-test fingerstick blood using the Blood Glucose Monitoring System (BGMS). BGMS results are compared with capillary plasma BG results obtained with a Yellow Springs Instrument (YSI) Analyzer. YSI Analyzer BG results are used to calculate the number of BGMS results within +/- 15mg/dL (\<100mg/dL YSI capillary plasma) or +/- 15% (\>=100mg/dL YSI capillary plasma).

Recruitment status

COMPLETED

Study phase

Target enrollment

102 participants

Primary outcome timeframe

1 hour

Results posted on

2016-02-29

Participant Flow

Participant milestones

Participant milestones
Measure	Intended Users of the Monitoring System Untrained subjects with diabetes use Contour TS Blood Glucose Monitoring System.
Overall Study STARTED	102
Overall Study COMPLETED	102
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Performance Evaluation of Blood Glucose Monitoring System Using ISO Study Design

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Intended Users of the Monitoring System n=102 Participants Untrained subjects with diabetes use Contour TS Blood Glucose Monitoring System.
Age, Continuous	55 years n=5 Participants
Sex: Female, Male Female	53 Participants n=5 Participants
Sex: Female, Male Male	49 Participants n=5 Participants
Region of Enrollment United States	102 participants n=5 Participants

PRIMARY outcome

Timeframe: 1 hour

Population: 102 untrained subjects tested one test strip lot on the Contour TS Blood Glucose Monitoring System.

Outcome measures

Outcome measures
Measure	Intended Users of the Monitoring System n=102 BG test results Untrained subjects with diabetes use Contour TS Blood Glucose Monitoring System.
Number of Self-Test Fingerstick Blood Glucose Results Within +/- 15mg/dL (<100mg/dL) or Within +/- 15% (>=100mg/dL) of Laboratory Glucose Method	84 Number of BG Test Results

SECONDARY outcome

Timeframe: 1 hour

Population: 102 untrained subjects tested one test strip lot on the Contour TS Blood Glucose Monitoring System

Untrained subjects with diabetes self-test Alternative Site (AST) Palm blood using the Blood Glucose Monitoring System (BGMS). BGMS AST palm results are compared with capillary plasma BG results obtained with a Yellow Springs Instrument (YSI) Analyzer. YSI capillary plasma BG results are used to calculate the number of AST palm BGMS results within +/- 15mg/dL (\<100mg/dL YSI capillary plasma) or +/- 15% (\>=100mg/dL YSI capillary plasma).

Outcome measures

Outcome measures
Measure	Intended Users of the Monitoring System n=102 BG test results Untrained subjects with diabetes use Contour TS Blood Glucose Monitoring System.
Number of Self-Test Alternative Site (Palm) Blood Glucose Results Within +/- 15mg/dL (<100mg/dL) or Within +/- 15% (>=100mg/dL) of Laboratory Glucose Method	78 Number of BG Test Results

SECONDARY outcome

Timeframe: 1 hour

Population: 102 untrained subjects tested one test strip lot using the Contour TS BG Monitoring System. One subject was unable to obtain sufficient sample volume to test. Another subject's meter displayed

Untrained subjects with diabetes self-test Alternative Site (AST) Forearm blood using the Blood Glucose Monitoring System (BGMS). BGMS AST forearm results are compared with capillary plasma BG results obtained with a Yellow Springs Instrument (YSI) Analyzer. YSI capillary plasma BG results are used to calculate the number of AST forearm BGMS results within +/- 15mg/dL (\<100mg/dL YSI capillary plasma) or +/- 15% (\>=100mg/dL YSI capillary plasma).

Outcome measures

Outcome measures
Measure	Intended Users of the Monitoring System n=100 BG test results Untrained subjects with diabetes use Contour TS Blood Glucose Monitoring System.
Number of Self-Test Alternative Site (Forearm) Blood Glucose Results Within +/- 15mg/dL (<100mg/dL) or Within +/- 15% (>=100mg/dL) of Laboratory Glucose Method	83 Number of BG Test Results

SECONDARY outcome

Timeframe: 1 hour

Subjects will complete short questionnaires to provide feedback on the labeling materials and system ease of use. Subjects may respond 'Strongly Agree' 'Agree' 'Neutral' 'Disagree' 'Strongly Disagree'.

Outcome measures

Outcome measures
Measure	Intended Users of the Monitoring System n=102 Participants Untrained subjects with diabetes use Contour TS Blood Glucose Monitoring System.
Number of Subject Responses That 'Agree' or 'Strongly Agree' With Questionnaire Statements I found it easy to do a blood test w this meter	98 participants
Number of Subject Responses That 'Agree' or 'Strongly Agree' With Questionnaire Statements Meter display (test result) is easy to read	102 participants
Number of Subject Responses That 'Agree' or 'Strongly Agree' With Questionnaire Statements Easy to see and understand the test results	101 participants
Number of Subject Responses That 'Agree' or 'Strongly Agree' With Questionnaire Statements I like the overall meter design	80 participants
Number of Subject Responses That 'Agree' or 'Strongly Agree' With Questionnaire Statements Meter is easy to handle	90 participants
Number of Subject Responses That 'Agree' or 'Strongly Agree' With Questionnaire Statements Easy to handle the individual test strips	64 participants
Number of Subject Responses That 'Agree' or 'Strongly Agree' With Questionnaire Statements Instructions (User Guide) easy to understand	97 participants
Number of Subject Responses That 'Agree' or 'Strongly Agree' With Questionnaire Statements Instructions clearly explain how to run a test	101 participants
Number of Subject Responses That 'Agree' or 'Strongly Agree' With Questionnaire Statements Instructions clearly explain meter error message	98 participants
Number of Subject Responses That 'Agree' or 'Strongly Agree' With Questionnaire Statements I found this meter easy to use	100 participants
Number of Subject Responses That 'Agree' or 'Strongly Agree' With Questionnaire Statements I found this meter intuitive	96 participants
Number of Subject Responses That 'Agree' or 'Strongly Agree' With Questionnaire Statements I found this meter practical	97 participants

Adverse Events

Intended Users of the Monitoring System

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Intended Users of the Monitoring System n=102 participants at risk Untrained subjects with diabetes use Contour TS Blood Glucose Monitoring System.
Endocrine disorders hypoglycemia	2.0% 2/102 • Number of events 2

Additional Information

Carmine Greene

Ascensia Diabetes Care

Phone: 574-257-3040

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place