Trial Outcomes & Findings for Study of an Investigational Glucose Meter System (NCT NCT01466075)

Results Overview

Untrained subjects with diabetes self-test fingerstick blood using the Apollo Evolution 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 +/- 15mg/dL (\<75mg/dL YSI capillary plasma) or +/- 20% (\>=75mg/dL YSI capillary plasma). Site staff tested in parallel after subjects.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

207 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 Apollo Evolution Investigational Blood Glucose Monitoring System. Apollo Evolution Investigational BG Monitoring System : Untrained subjects with diabetes perform self Blood Glucose (BG) tests with capillary fingerstick blood and AST of the palm using the Apollo Evolution meter and an investigational sensor. Study staff test subject venous blood. All BG results are compared to a reference laboratory glucose method. Untrained subjects complete basic tasks using the User Guide and provide feedback.
Overall Study STARTED	207
Overall Study COMPLETED	207
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

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=207 Participants Untrained subjects with diabetes use the Apollo Evolution Investigational Blood Glucose Monitoring System. Apollo Evolution Investigational BG Monitoring System : Untrained subjects with diabetes perform self Blood Glucose (BG) tests with capillary fingerstick blood and AST of the palm using the Apollo Evolution meter and an investigational sensor. Study staff test subject venous blood. All BG results are compared to a reference laboratory glucose method. Untrained subjects complete basic tasks using the User Guide and provide feedback.
Age, Continuous	55.7 years n=5 Participants
Sex: Female, Male Female	117 Participants n=5 Participants
Sex: Female, Male Male	90 Participants n=5 Participants
Region of Enrollment United States	207 participants n=5 Participants

PRIMARY outcome

Timeframe: 1 hour

Population: Blood data for three subjects were not evaluable because the difference between the replicates of the reference YSI analyzer measurements exceeded the protocol defined criteria. Remaining 204 subjects each tested one of three test strip lots on the system. 204 (207-3) test results were available.

Untrained subjects with diabetes self-test fingerstick blood using the Apollo Evolution 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 +/- 15mg/dL (\<75mg/dL YSI capillary plasma) or +/- 20% (\>=75mg/dL YSI capillary plasma). Site staff tested in parallel after subjects.

Outcome measures

Outcome measures
Measure	Intended Users of the Monitoring System n=204 Blood Glucose Test Results Untrained subjects with diabetes use the Apollo Evolution Investigational Blood Glucose Monitoring System. Apollo Evolution Investigational BG Monitoring System : Untrained subjects with diabetes perform self Blood Glucose (BG) tests with capillary fingerstick blood and AST of the palm using the Apollo Evolution meter and an investigational sensor. Study staff test subject venous blood. All BG results are compared to a reference laboratory glucose method. Untrained subjects complete basic tasks using the User Guide and provide feedback.
Percent of Self-Test Fingerstick Blood Glucose Results Within +/- 15mg/dL (<75mg/dL) or Within +/- 20% (>=75mg/dL) of Laboratory Glucose Method	99.51 percentage of Blood Glucose Test Results

SECONDARY outcome

Timeframe: 1 hour

Population: Blood data for three subjects were not evaluable because the difference between the replicates of the reference YSI analyzer measurements exceeded the protocol defined criteria. The remaining 204 subjects each tested one of three test strip lots on the system. 204 (207-3) test results were available.

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 Monitoring System n=204 Blood Glucose Test Results Untrained subjects with diabetes use the Apollo Evolution Investigational Blood Glucose Monitoring System. Apollo Evolution Investigational BG Monitoring System : Untrained subjects with diabetes perform self Blood Glucose (BG) tests with capillary fingerstick blood and AST of the palm using the Apollo Evolution meter and an investigational sensor. Study staff test subject venous blood. All BG results are compared to a reference laboratory glucose method. Untrained subjects complete basic tasks 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	99.51 percentage of Blood Glucose Test Results

SECONDARY outcome

Timeframe: 1 hour

Population: 609 venous BG results(203 subjects x 3 test strip lots) were available. Three subjects did not have successful venipunctures so no blood obtained. BGMS testing was not performed with one subject's blood sample. Study staff tested each subject venous blood sample using 3 test strip lots.

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 +/- 15mg/dL (\<75mg/dL YSI venous plasma) or +/- 20% (\>=75mg/dL YSI venous plasma).

Outcome measures

Outcome measures
Measure	Intended Users of the Monitoring System n=609 Venous BG Test Results Untrained subjects with diabetes use the Apollo Evolution Investigational Blood Glucose Monitoring System. Apollo Evolution Investigational BG Monitoring System : Untrained subjects with diabetes perform self Blood Glucose (BG) tests with capillary fingerstick blood and AST of the palm using the Apollo Evolution meter and an investigational sensor. Study staff test subject venous blood. All BG results are compared to a reference laboratory glucose method. Untrained subjects complete basic tasks using the User Guide and provide feedback.
Percent of Venous Blood Glucose Results Within +/- 15mg/dL (<75mg/dL) or Within +/- 20% (>=75mg/dL) of Laboratory Glucose Method	100.0 percentage of Blood Glucose Test Results

SECONDARY outcome

Timeframe: 1 hour

Population: Blood data for three subjects were not considered evaluable because the difference between the replicates of the reference YSI analyzer measurements exceeded the protocol defined criteria. Remaining 204 subjects each tested one of three test strip lots on the system. 204 (207-3) test results were available.

After reading the instructions for use, and without assistance from the study staff, subjects use the BGMS to perform basic tasks considered to be essential for the operation of the system.

Outcome measures

Outcome measures
Measure	Intended Users of the Monitoring System n=204 Participants Untrained subjects with diabetes use the Apollo Evolution Investigational Blood Glucose Monitoring System. Apollo Evolution Investigational BG Monitoring System : Untrained subjects with diabetes perform self Blood Glucose (BG) tests with capillary fingerstick blood and AST of the palm using the Apollo Evolution meter and an investigational sensor. Study staff test subject venous blood. All BG results are compared to a reference laboratory glucose method. Untrained subjects complete basic tasks using the User Guide and provide feedback.
Number of Subjects Able to Perform Given Tasks Using Product Labeling for Instruction Successfully performed fingerstick BG test	203 participants
Number of Subjects Able to Perform Given Tasks Using Product Labeling for Instruction Successfully performed palm AST BG test	203 participants

Adverse Events

Intended Users of the Monitoring System

Serious events: 0 serious events

Other events: 1 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=207 participants at risk Untrained subjects with diabetes use the Apollo Evolution Investigational Blood Glucose Monitoring System. Apollo Evolution Investigational BG Monitoring System : Untrained subjects with diabetes perform self Blood Glucose (BG) tests with capillary fingerstick blood and AST of the palm using the Apollo Evolution meter and an investigational sensor. Study staff test subject venous blood. All BG results are compared to a reference laboratory glucose method. Untrained subjects complete basic tasks using the User Guide and provide feedback.
Endocrine disorders hypoglycemia	0.48% 1/207 • 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