Diabetes
Conditions
Brief summary
This clinical trial is designed to assess an investigational blood glucose monitoring system with fingerstick blood in the hands of untrained intended users.
Interventions
DEVICETatsu/Tradewind Investigational BG Monitoring System
Tradewind is a Bayer investigational meter that used an investigational sensor.
Sponsors
Ascensia Diabetes Care
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Type 1 or type 2 diabetes * 18 years of age and older * Able to speak, read, and understand English * Willing to complete all study procedures
Exclusion criteria
* Previously participated in a study using this investigational system * Working for a medical laboratory, hospital, or other clinical setting that involves training on and clinical use of blood glucose monitors * Pregnancy * Hemophilia or any other bleeding disorder * Working for a competitive medical device company or having an immediate family member or someone who is not a family member but is living within the household of someone who works for such a company * A condition which, in the opinion of the investigator, would put the person or study conduct at risk (reason for exclusion will be clearly documented by investigator or designee).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 | 1 hour | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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) | 1 hour | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Intended Users of the System 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.) | 116 |
| Total | 116 |
Baseline characteristics
| Characteristic | Intended Users of the System |
|---|---|
| Age, Customized | 52.3 years |
| Region of Enrollment United States | 116 participants |
| Sex: Female, Male Female | 61 Participants |
| Sex: Female, Male Male | 55 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 5 / 118 |
| serious Total, serious adverse events | 0 / 118 |
Outcome results
Primary
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
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).
Time frame: 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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Intended Users of the System | 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
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)
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.
Time frame: 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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Intended Users of the System | 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 |