Trial Outcomes & Findings for Study of an Investigational Glucose Meter System (NCT NCT01474317)

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. 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). Site staff tested in parallel after subjects.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

226 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 the G3 investigational blood glucose monitoring system. G3 Investigational Blood Glucose Monitoring System : Untrained subjects with diabetes perform self Blood Glucose (BG) tests with capillary fingerstick blood and AST of the palm using the G3 meter and an investigational sensor. Study staff test subject venous blood and all BG results are compared to a reference laboratory glucose method. Untrained subjects utilize some additional features of the meter using the User Guide and provide feedback.
Overall Study STARTED	226
Overall Study COMPLETED	224
Overall Study NOT COMPLETED	2

Reasons for withdrawal

Reasons for withdrawal
Measure	Intended Users of the Monitoring System Untrained subjects with diabetes use the G3 investigational blood glucose monitoring system. G3 Investigational Blood Glucose Monitoring System : Untrained subjects with diabetes perform self Blood Glucose (BG) tests with capillary fingerstick blood and AST of the palm using the G3 meter and an investigational sensor. Study staff test subject venous blood and all BG results are compared to a reference laboratory glucose method. Untrained subjects utilize some additional features of the meter using the User Guide and provide feedback.
Overall Study Adverse Event	1
Overall Study Subject ineligible for study	1

Baseline Characteristics

Study of an Investigational Glucose Meter System

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Intended Users of the Monitoring System n=224 Participants Untrained subjects with diabetes use the G3 investigational blood glucose monitoring system. Of 226 subjects enrolled, 224 completed the study G3 Investigational Blood Glucose Monitoring System : Untrained subjects with diabetes perform self Blood Glucose (BG) tests with capillary fingerstick blood and AST of the palm using the G3 meter and an investigational sensor. Study staff test subject venous blood and all BG results are compared to a reference laboratory glucose method. Untrained subjects utilize some additional features of the meter using the User Guide and provide feedback.
Age, Continuous	54.4 years n=5 Participants
Sex: Female, Male Female	131 Participants n=5 Participants
Sex: Female, Male Male	93 Participants n=5 Participants
Region of Enrollment United States	224 participants n=5 Participants

PRIMARY outcome

Timeframe: 1 hour

Population: Blood data for three subjects were not evaluable because time defined in protocol was exceeded between meter test and blood sample preparation for reference method. 221 (224-3) blood test results were analyzed.

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. 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). Site staff tested in parallel after subjects.

Outcome measures

Outcome measures
Measure	Intended Users of the G3 Investigational BG Monitoring System n=221 Participants Untrained subjects with diabetes use the G3 investigational blood glucose monitoring system. Of 226 subjects enrolled, 224 completed the study. G3 Investigational Blood Glucose Monitoring System : Untrained subjects with diabetes perform self Blood Glucose (BG) tests with capillary fingerstick blood and AST of the palm using the G3 meter and an investigational sensor. Study staff test subject venous blood and all BG results are compared to a reference laboratory glucose method. Untrained subjects utilize some additional features of the meter using the User Guide and provide feedback.
Percent of Self-Test Fingerstick Blood Glucose Results Within +/- 5to15mg/dL (<100mg/dL) or Within +/- 5to15% (>=100mg/dL) of Laboratory Glucose Method % within 15 mg/dL(<100 mg/dL BG)	100 percentage of meter test results
Percent of Self-Test Fingerstick Blood Glucose Results Within +/- 5to15mg/dL (<100mg/dL) or Within +/- 5to15% (>=100mg/dL) of Laboratory Glucose Method % within 15% (>=100 mg/dL BG)	98.9 percentage of meter test results
Percent of Self-Test Fingerstick Blood Glucose Results Within +/- 5to15mg/dL (<100mg/dL) or Within +/- 5to15% (>=100mg/dL) of Laboratory Glucose Method % within 12.5 mg/dL (<100 mg/dL BG)	100 percentage of meter test results
Percent of Self-Test Fingerstick Blood Glucose Results Within +/- 5to15mg/dL (<100mg/dL) or Within +/- 5to15% (>=100mg/dL) of Laboratory Glucose Method % within 12.5% (>=100 mg/dL BG)	98.4 percentage of meter test results
Percent of Self-Test Fingerstick Blood Glucose Results Within +/- 5to15mg/dL (<100mg/dL) or Within +/- 5to15% (>=100mg/dL) of Laboratory Glucose Method % within 10 mg/dL (<100 mg/dL BG)	100 percentage of meter test results
Percent of Self-Test Fingerstick Blood Glucose Results Within +/- 5to15mg/dL (<100mg/dL) or Within +/- 5to15% (>=100mg/dL) of Laboratory Glucose Method % within 10% (>=100 mg/dL BG)	95.6 percentage of meter test results
Percent of Self-Test Fingerstick Blood Glucose Results Within +/- 5to15mg/dL (<100mg/dL) or Within +/- 5to15% (>=100mg/dL) of Laboratory Glucose Method % within 5 mg/dL (<100 mg/dL BG)	76.9 percentage of meter test results
Percent of Self-Test Fingerstick Blood Glucose Results Within +/- 5to15mg/dL (<100mg/dL) or Within +/- 5to15% (>=100mg/dL) of Laboratory Glucose Method % within 5% (>=100 mg/dL BG)	78.6 percentage of meter test results

SECONDARY outcome

Timeframe: 1 hour

Population: Blood data for 3 subjects were not evaluable because time defined in protocol was exceeded between meter test and blood sample preparation for reference method. 221 (224-3) blood test results were analyzed.

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. YSI capillary plasma 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).

Outcome measures

Outcome measures
Measure	Intended Users of the G3 Investigational BG Monitoring System n=221 Participants Untrained subjects with diabetes use the G3 investigational blood glucose monitoring system. Of 226 subjects enrolled, 224 completed the study. G3 Investigational Blood Glucose Monitoring System : Untrained subjects with diabetes perform self Blood Glucose (BG) tests with capillary fingerstick blood and AST of the palm using the G3 meter and an investigational sensor. Study staff test subject venous blood and all BG results are compared to a reference laboratory glucose method. Untrained subjects utilize some additional features of the meter using the User Guide and provide feedback.
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 % within 15 mg/dL (<75 mg/dL BG)	100 percentage of meter test results
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 % within 20% (>=75 mg/dL BG)	99.1 percentage of meter test results

SECONDARY outcome

Timeframe: 1 hour

Population: Venipuncture was unsuccessful for one subject. 223 (224-1) venous blood test results were analyzed.

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. YSI venous plasma results are used to calculate the number of BGMS results within +/- 5to15mg/dL (\<75mg/dL YSI venous plasma) or +/- 5to20% (\>=75mg/dL YSI venous plasma).

Outcome measures

Outcome measures
Measure	Intended Users of the G3 Investigational BG Monitoring System n=223 Participants Untrained subjects with diabetes use the G3 investigational blood glucose monitoring system. Of 226 subjects enrolled, 224 completed the study. G3 Investigational Blood Glucose Monitoring System : Untrained subjects with diabetes perform self Blood Glucose (BG) tests with capillary fingerstick blood and AST of the palm using the G3 meter and an investigational sensor. Study staff test subject venous blood and all BG results are compared to a reference laboratory glucose method. Untrained subjects utilize some additional features of the meter using the User Guide and provide feedback.
Percent of Venous Blood Glucose Results Within +/- 5to15mg/dL (<75mg/dL) or Within +/- 5to20% (>=75mg/dL) of Laboratory Glucose Method % within 20% (>=75 mg/dL BG)	100 percentage of meter test results
Percent of Venous Blood Glucose Results Within +/- 5to15mg/dL (<75mg/dL) or Within +/- 5to20% (>=75mg/dL) of Laboratory Glucose Method % within 15% (>=75 mg/dL BG)	99.5 percentage of meter test results
Percent of Venous Blood Glucose Results Within +/- 5to15mg/dL (<75mg/dL) or Within +/- 5to20% (>=75mg/dL) of Laboratory Glucose Method %within 15 mg/dL (<75 mg/dL BG)	100 percentage of meter test results
Percent of Venous Blood Glucose Results Within +/- 5to15mg/dL (<75mg/dL) or Within +/- 5to20% (>=75mg/dL) of Laboratory Glucose Method % within 12.5% (>=75 mg/dL BG)	99.1 percentage of meter test results
Percent of Venous Blood Glucose Results Within +/- 5to15mg/dL (<75mg/dL) or Within +/- 5to20% (>=75mg/dL) of Laboratory Glucose Method % within 12.5 mg/dL (<75 mg/dL BG)	100 percentage of meter test results
Percent of Venous Blood Glucose Results Within +/- 5to15mg/dL (<75mg/dL) or Within +/- 5to20% (>=75mg/dL) of Laboratory Glucose Method % within 10% (>=75 mg/dL BG)	98.6 percentage of meter test results
Percent of Venous Blood Glucose Results Within +/- 5to15mg/dL (<75mg/dL) or Within +/- 5to20% (>=75mg/dL) of Laboratory Glucose Method % within 10 mg/dL (<75 mg/dL BG)	100 percentage of meter test results
Percent of Venous Blood Glucose Results Within +/- 5to15mg/dL (<75mg/dL) or Within +/- 5to20% (>=75mg/dL) of Laboratory Glucose Method % within 5% (>=75 mg/dL BG)	71.4 percentage of meter test results
Percent of Venous Blood Glucose Results Within +/- 5to15mg/dL (<75mg/dL) or Within +/- 5to20% (>=75mg/dL) of Laboratory Glucose Method % within 5 mg/dL (<75 mg/dL BG)	83.3 percentage of meter test results

SECONDARY outcome

Timeframe: 1 hour

After reading the instructions for use, and without assistance from the study staff, subjects use the BGMS to utilize some of the additional features of the system. Study staff documents Yes or No 'Did the subject complete the task successfully?'

Outcome measures

Outcome measures
Measure	Intended Users of the G3 Investigational BG Monitoring System n=224 Participants Untrained subjects with diabetes use the G3 investigational blood glucose monitoring system. Of 226 subjects enrolled, 224 completed the study. G3 Investigational Blood Glucose Monitoring System : Untrained subjects with diabetes perform self Blood Glucose (BG) tests with capillary fingerstick blood and AST of the palm using the G3 meter and an investigational sensor. Study staff test subject venous blood and all BG results are compared to a reference laboratory glucose method. Untrained subjects utilize some additional features of the meter using the User Guide and provide feedback.
Number of Subjects Able to Perform Given Tasks Using Product Labeling for Instruction Mark a test result as 'Before Meal'	208 participants
Number of Subjects Able to Perform Given Tasks Using Product Labeling for Instruction Set a reminder	203 participants
Number of Subjects Able to Perform Given Tasks Using Product Labeling for Instruction Access BG trends	215 participants

Adverse Events

Intended Users of the G3 Investigational BG Monitoring System

Serious events: 0 serious events

Other events: 4 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Intended Users of the G3 Investigational BG Monitoring System n=224 participants at risk Untrained subjects with diabetes use the G3 investigational blood glucose monitoring system. Of 226 subjects enrolled, 224 completed the study. G3 Investigational Blood Glucose Monitoring System : Untrained subjects with diabetes perform self Blood Glucose (BG) tests with capillary fingerstick blood and AST of the palm using the G3 meter and an investigational sensor. Study staff test subject venous blood and all BG results are compared to a reference laboratory glucose method. Untrained subjects utilize some additional features of the meter using the User Guide and provide feedback.
Endocrine disorders Hypoglycemia	1.3% 3/224 • Number of events 3
Endocrine disorders Hyperglycemia	0.45% 1/224 • Number of events 1

Additional Information

Jane Wallace

Ascensia Diabetes Care

Phone: 574-257-3063

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: GT60