Trial Outcomes & Findings for User Study of an Investigational Blood Glucose Monitoring System (NCT NCT01447121)

Results Overview

Untrained subjects with diabetes tested self-test fingerstick blood using an investigational Blood Glucose Monitoring System (BGMS), which included an investigational meter and sensor. BGM results were compared with capillary plasm BG results obtained with a reference lab glucose method - Yellow Springs Instrument (YSI) Analyzer. BG meter results were used to calculate the number of BG results within +/- 15 mg/dL (for reference BG results \<75mg/dL) or +/- 20% (for reference BG results \>=75mg/dL) of the reference method results (YSI capillary plasma).

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

118 participants

Primary outcome timeframe

1 hour

Results posted on

2016-02-29

Participant Flow

Participant milestones

Participant milestones
Measure	Intended Users of the System Untrained subjects with diabetes use an investigational blood glucose monitoring system (Tatsu/Tradewind Investigational BG Monitoring System) to self-test capillary blood obtained from fingerstick. Tatsu/Tradewind Investigational BG Monitoring System : Tradewind is a Bayer investigational meter that used an investigational sensor.
Overall Study STARTED	118
Overall Study COMPLETED	118
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

User Study of an Investigational Blood Glucose Monitoring System

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Intended Users of the System n=116 Participants Study results from 2 subjects were excluded from all data analysis, because study staff inadvertently performed study tasks that could be considered 'training' them. (According to protocol, training was not allowed.)
Age, Customized	52.3 years n=5 Participants
Sex: Female, Male Female	61 Participants n=5 Participants
Sex: Female, Male Male	55 Participants n=5 Participants
Region of Enrollment United States	116 participants n=5 Participants

PRIMARY outcome

Timeframe: 1 hour

Population: 115(115x1)test results are possible. 118 subjects tested one of 3 test strip lots on the BGM system. Study results from 2 subjects were excluded from all data analyses as already described. One subject test exceeded time interval (defined in protocol) between meter test and reference method.

Untrained subjects with diabetes tested self-test fingerstick blood using an investigational Blood Glucose Monitoring System (BGMS), which included an investigational meter and sensor. BGM results were compared with capillary plasm BG results obtained with a reference lab glucose method - Yellow Springs Instrument (YSI) Analyzer. BG meter results were used to calculate the number of BG results within +/- 15 mg/dL (for reference BG results \<75mg/dL) or +/- 20% (for reference BG results \>=75mg/dL) of the reference method results (YSI capillary plasma).

Outcome measures

Outcome measures
Measure	Intended Users of the System n=115 BG test results Untrained subjects with diabetes use an investigational blood glucose monitoring system (Tatsu/Tradewind Investigational BG Monitoring System) to self-test capillary blood obtained from fingerstick. Tatsu/Tradewind Investigational BG Monitoring System : Tradewind is a Bayer investigational meter that used an investigational sensor.
Number of Self-Test Fingerstick Blood Glucose (BG) Results Within +/- 15mg/dL (<75 mg/dL) or Within +/- 20% (>=75 mg/dL) of Laboratory Glucose Method	115 BG test results

SECONDARY outcome

Timeframe: 1 hour

Population: 115 (115x1) test results are possible. Staff tested blood from 118 subjects (one of 3 test strip lots). All study results from 2 subjects were excluded from data analyses as already described. Also, one test exceeded time interval (defined in protocol) between meter test and reference method.

Study staff tested subject fingerstick blood using an investigational Blood Glucose Monitoring System (BGMS), which included an investigational meter and sensor. BGM results were compared with capillary plasma BG results obtained with a reference lab glucose method - Yellow Springs Instrument (YSI) Analyzer. BG meter results were used to calculate the number of BG results within +/- 15mg/dL (for reference BG results \<75mg/dL) or +/- 20% (for reference BG results \>=75mg/dL) of the reference method results.

Outcome measures

Outcome measures
Measure	Intended Users of the System n=115 Participants Untrained subjects with diabetes use an investigational blood glucose monitoring system (Tatsu/Tradewind Investigational BG Monitoring System) to self-test capillary blood obtained from fingerstick. Tatsu/Tradewind Investigational BG Monitoring System : Tradewind is a Bayer investigational meter that used an investigational sensor.
Number of Study Staff Results Within +/- 15mg/dL (<75 mg/dL) or Within +/- 20% (>=75 mg/dL) of Laboratory Glucose Method When Testing Subject Blood Glucose (BG)	115 BG test results

Adverse Events

Intended Users of the System

Serious events: 0 serious events

Other events: 5 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Intended Users of the System n=118 participants at risk Untrained subjects with diabetes use an investigational blood glucose monitoring system (Tatsu/Tradewind Investigational BG Monitoring System) to self-test capillary blood obtained from fingerstick. Tatsu/Tradewind Investigational BG Monitoring System : Tradewind is a Bayer investigational meter that used an investigational sensor.
Endocrine disorders hypoglycemia	4.2% 5/118 • Number of events 5

Additional Information

Carmine Greene, Senior Clinical Research Scientist

Ascensia Diabetes Care

Phone: 574-257-3062

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: GT60