Trial Outcomes & Findings for Performance Evaluation of an Investigational Blood Glucose Monitoring System (NCT NCT01598610)

Results Overview

Untrained subjects with diabetes self-test fingerstick blood using an investigational Blood Glucose Monitoring System (BGMS). BGMS results are compared with capillary plasma BG results obtained with a Yellow Springs Instrument (YSI) Analyzer. BG results are used to calculate the number of BGMS results within +/- 15mg/dL (\<75mg/dL YSI capillary plasma) or +/- 20% (\>=75mg/dL YSI capillary plasma) of the reference method results.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

220 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® PLUS Investigational BG Monitoring System.
Overall Study STARTED	220
Overall Study COMPLETED	219
Overall Study NOT COMPLETED	1

Reasons for withdrawal

Reasons for withdrawal
Measure	Intended Users of the Monitoring System Untrained subjects with diabetes use CONTOUR® PLUS Investigational BG Monitoring System.
Overall Study Adverse Event	1

Baseline Characteristics

Performance Evaluation of an Investigational Blood Glucose Monitoring System

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Intended Users of the Monitoring System n=220 Participants Untrained subjects with diabetes use CONTOUR® PLUS Investigational BG Monitoring System.
Age, Continuous	60 years n=5 Participants
Sex: Female, Male Female	118 Participants n=5 Participants
Sex: Female, Male Male	102 Participants n=5 Participants
Region of Enrollment United States	220 participants n=5 Participants

PRIMARY outcome

Timeframe: 1 hour

Population: 216 (220-4) blood test results were analyzed. Blood data for 2 subjects were not evaluable because time, defined in protocol, was exceeded between meter test and blood sample preparation for reference method. No fingerstick results were obtained for 2 subjects.

Untrained subjects with diabetes self-test fingerstick blood using an investigational Blood Glucose Monitoring System (BGMS). BGMS results are compared with capillary plasma BG results obtained with a Yellow Springs Instrument (YSI) Analyzer. BG results are used to calculate the number of BGMS results within +/- 15mg/dL (\<75mg/dL YSI capillary plasma) or +/- 20% (\>=75mg/dL YSI capillary plasma) of the reference method results.

Outcome measures

Outcome measures
Measure	Intended Users of the Monitoring System n=216 Participants Untrained subjects with diabetes use CONTOUR® PLUS Investigational BG Monitoring System.
Percent of Self-Test Fingerstick Blood Glucose Results Within +/- 15mg/dL (<75mg/dL) or Within +/- 20% (>=75mg/dL) of Laboratory Glucose Method	100 percentage of BG Test Results

SECONDARY outcome

Timeframe: 1 hour

Population: 213 (220-7) blood test results were analyzed. Four(4) subjects had low blood sugar and AST results were not evaluable per protocol. One(1) subject with low blood sugar (AE) did not attempt AST testing per protocol. No AST palm results were obtained for 2 subjects.

Untrained subjects with diabetes self-test Alternative Site (AST) Palm blood using an investigational Blood Glucose Monitoring System (BGMS). BGMS AST results are compared with capillary plasma BG results obtained with a Yellow Springs Instrument (YSI) Analyzer. BG results are used to calculate the number of AST BGMS results within +/- 15mg/dL (\<75mg/dL YSI capillary plasma) or +/- 20% (\>=75mg/dL YSI capillary plasma) of the reference method results.

Outcome measures

Outcome measures
Measure	Intended Users of the Monitoring System n=213 Participants Untrained subjects with diabetes use CONTOUR® PLUS Investigational BG Monitoring System.
Percent of Glucose Results From Alternative Site Testing (AST) of the Palm Within +/- 15mg/dL (<75mg/dL) or Within +/- 20% (>=75mg/dL) of Laboratory Glucose Method	98.1 percentage of BG Test Results

SECONDARY outcome

Timeframe: 1 hour

Population: 213 (220-7) blood test results were analyzed. Venipuncture was unsuccessful for 6 subjects. Blood data for 1 subject was not evaluable because time, defined in protocol, was exceeded between meter test and blood sample preparation for reference method.

Study staff tested subject venous blood using an investigational Blood Glucose Monitoring System (BGMS). Venous BGMS results are compared with venous plasma BG results obtained with a Yellow Springs Instrument (YSI) Analyzer. Venous plasma BG results are used to calculate the number of BGMS results within +/- 15mg/dL (\<75mg/dL YSI venous plasma) or +/- 20% (\>=75mg/dL YSI venous plasma) of the reference method results.

Outcome measures

Outcome measures
Measure	Intended Users of the Monitoring System n=213 Participants Untrained subjects with diabetes use CONTOUR® PLUS Investigational BG Monitoring System.
Percent of Venous Blood Glucose Results Within +/- 15mg/dL (<75mg/dL) or Within +/- 20% (>=75mg/dL) of Laboratory Glucose Method	99.5 percentage of BG Test Results

SECONDARY outcome

Timeframe: 1 hour

Population: 108 (110-2) blood test results from one test strip lot were analyzed. Blood data for 1 subject was not evaluable because time, defined in protocol, was exceeded between meter test and blood sample preparation for reference method. No fingerstick result was obtained for 1 subject.

Untrained subjects with diabetes self-test fingerstick blood using an investigational Blood Glucose Monitoring System (BGMS). BGMS results are compared with capillary plasma BG results obtained with a Yellow Springs Instrument (YSI) Analyzer. BG results are used to calculate the number of BGMS results within +/- 5to15mg/dL (\<100mg/dL YSI capillary plasma) or +/- 5to15% (\>=100mg/dL YSI capillary plasma) of the reference method results.

Outcome measures

Outcome measures
Measure	Intended Users of the Monitoring System n=108 Participants Untrained subjects with diabetes use CONTOUR® PLUS Investigational BG Monitoring System.
Percent of Self-Test Fingerstick Blood Glucose Results Within +/- 5to15mg/dL (<100mg/dL) or Within +/- 5to15% (>=100mg/dL) of Laboratory Glucose Method % within +/-15mg/dL(<100mg/dL) or 15% (>=100mg/dL)	98.2 percentage of BG Test Results
Percent of Self-Test Fingerstick Blood Glucose Results Within +/- 5to15mg/dL (<100mg/dL) or Within +/- 5to15% (>=100mg/dL) of Laboratory Glucose Method w/in +/-12.5mg/dL(<100mg/dL) or 12.5% (>=100mg/dL)	93.5 percentage of BG Test Results
Percent of Self-Test Fingerstick Blood Glucose Results Within +/- 5to15mg/dL (<100mg/dL) or Within +/- 5to15% (>=100mg/dL) of Laboratory Glucose Method w/in +/-10mg/dL(<100mg/dL) or +/- 10% (>=100mg/dL)	86.1 percentage of BG Test Results
Percent of Self-Test Fingerstick Blood Glucose Results Within +/- 5to15mg/dL (<100mg/dL) or Within +/- 5to15% (>=100mg/dL) of Laboratory Glucose Method w/in +/-5mg/dL(<100mg/dL) or +/- 5% (>=100mg/dL)	53.7 percentage of BG Test Results

SECONDARY outcome

Timeframe: 1 hour

Population: 217 (220-3) blood test results were analyzed. Blood data for 2 subjects were not evaluable because time, defined in protocol, was exceeded between meter test and blood sample preparation for reference method. No fingerstick results were obtained for 1 subject.

Study staff test subject fingerstick blood using an investigational Blood Glucose Monitoring System (BGMS). BGMS results are compared with capillary plasma BG results obtained with a Yellow Springs Instrument (YSI) Analyzer. BG results are used to calculate the number of BGMS results within +/- 15mg/dL (\<75mg/dL YSI capillary plasma) or +/- 20% (\>=75mg/dL YSI capillary plasma) of the reference method results.

Outcome measures

Outcome measures
Measure	Intended Users of the Monitoring System n=217 Participants Untrained subjects with diabetes use CONTOUR® PLUS Investigational BG Monitoring System.
Percent of Subject Fingerstick BG Results Within +/- 15mg/dL (<75mg/dL) or Within +/- 20% (>=75mg/dL) of Laboratory Glucose Method When Tested by Study Staff	99.5 percentage of BG Test Results

SECONDARY outcome

Timeframe: 1 hour

Population: Per protocol

Subjects respond to statements read by study staff to provide feedback on the labeling materials and system ease of use. Subjects may respond 'Strongly Agree' 'Agree' 'Neutral' 'Disagree' or 'Strongly Disagree'.

Outcome measures

Outcome measures
Measure	Intended Users of the Monitoring System n=220 Participants Untrained subjects with diabetes use CONTOUR® PLUS Investigational BG Monitoring System.
Number of Subject Responses 'Strongly Agree' 'Agree' or 'Neutral' With Questionnaire Statements I found it easy to do a blood test with this meter	215 participants
Number of Subject Responses 'Strongly Agree' 'Agree' or 'Neutral' With Questionnaire Statements Meter display(test result) is easy to see and read	220 participants
Number of Subject Responses 'Strongly Agree' 'Agree' or 'Neutral' With Questionnaire Statements It was easy to understand my test results.	218 participants
Number of Subject Responses 'Strongly Agree' 'Agree' or 'Neutral' With Questionnaire Statements I like the overall meter design.	218 participants
Number of Subject Responses 'Strongly Agree' 'Agree' or 'Neutral' With Questionnaire Statements I find the meter easy to handle.	218 participants
Number of Subject Responses 'Strongly Agree' 'Agree' or 'Neutral' With Questionnaire Statements Easy to handle the individual test strips.	218 participants
Number of Subject Responses 'Strongly Agree' 'Agree' or 'Neutral' With Questionnaire Statements Instructions (User Guide) easy to understand.	218 participants
Number of Subject Responses 'Strongly Agree' 'Agree' or 'Neutral' With Questionnaire Statements Instructions clearly explain how to run a test.	220 participants
Number of Subject Responses 'Strongly Agree' 'Agree' or 'Neutral' With Questionnaire Statements Instructions clearly explain meter error messages.	218 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=220 participants at risk Untrained subjects with diabetes use CONTOUR® PLUS Investigational BG Monitoring System.
Endocrine disorders hypoglycemia	0.45% 1/220 • Number of events 1
Endocrine disorders hyperglycemia	0.45% 1/220 • Number of events 1

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

Restriction type: GT60