Diabetes
Conditions
Brief summary
The purpose of this study is to determine the difference between self-reported, estimated blood glucose level versus blood glucose levels measured with a Blood Glucose Meter.
Interventions
OTHERBlood Glucose meter
Staff tested subject Blood Glucose using a Blood Glucose meter.
Sponsors
Ascensia Diabetes Care
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Males and females, 18 years of age and above 2. Type 2 diabetes 3. Able to speak, read, and understand English 4. Willing to complete all study procedures
Exclusion criteria
1. Type 1 diabetes 2. Currently a user of continuous glucose monitoring system 3. Currently pregnant 4. Hemophilia or any other bleeding disorder 5. Employee of competitive medical device company 6. Cognitive disorder or other condition which, in the opinion of the investigator (or designee), would put the person at risk or seriously compromise the integrity of the study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percent of Subjects Outside Specified Blood Glucose (BG) Range -Estimated Versus Measured Blood Glucose | 1 visit 15-20 minutes | The percent of subjects whose estimated blood glucose values are different than meter BG values. A calculation was performed to determine the percent of subjects whose estimated BG values are \> +/-20% different than meter BG values when samples have BG \>=75mg/dL or \> +/- 15mg/dL different than meter BG values when samples have BG \<75mg/dL, as measured by fingerstick CONTOUR®. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percent of Subjects Outside a Second Specified Blood Glucose (BG) Range -Estimated Versus Measured Blood Glucose | 1 visit 15-20 minutes | The percent of subjects whose estimated blood glucose values are different than meter BG values. A calculation was performed to determine the percent of subjects whose estimated BG values are \> +/-15% different than meter BG values when samples have BG \>=100 mg/dL or \> +/- 15 mg/dL different than meter BG values when samples have BG \<100 mg/dL, as measured by fingerstick CONTOUR®. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| People With Type 2 Diabetes People with type 2 diabetes who were in attendance at a diabetes conference were asked for their perceived Blood Glucose (BG) value. Then, after staff measured BG on Contour® Blood Glucose meter, subjects were informed of their BG value. Three subjects were excluded from all analyses due to inconsistencies in responses to inclusion / exclusion questions. So 294 subjects were included in demographics analyses. | 294 |
| Total | 294 |
Baseline characteristics
| Characteristic | People With Type 2 Diabetes |
|---|---|
| Age Continuous | 59 years |
| Region of Enrollment United States | 294 participants |
| Sex: Female, Male Female | 177 Participants |
| Sex: Female, Male Male | 117 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 3 / 297 |
| serious Total, serious adverse events | 0 / 297 |
Outcome results
Primary
Percent of Subjects Outside Specified Blood Glucose (BG) Range -Estimated Versus Measured Blood Glucose
The percent of subjects whose estimated blood glucose values are different than meter BG values. A calculation was performed to determine the percent of subjects whose estimated BG values are \> +/-20% different than meter BG values when samples have BG \>=75mg/dL or \> +/- 15mg/dL different than meter BG values when samples have BG \<75mg/dL, as measured by fingerstick CONTOUR®.
Time frame: 1 visit 15-20 minutes
Population: Three subjects were excluded from analyses due to inconsistencies in responses to inclusion/exclusion questions(297-3=294). Eight subjects were excluded from BG analyses because they did not have both an estimated BG value and a meter result (294-8=286)
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| People With Type 2 Diabetes | Percent of Subjects Outside Specified Blood Glucose (BG) Range -Estimated Versus Measured Blood Glucose | 45.80 percentage of subjects |
Secondary
Percent of Subjects Outside a Second Specified Blood Glucose (BG) Range -Estimated Versus Measured Blood Glucose
The percent of subjects whose estimated blood glucose values are different than meter BG values. A calculation was performed to determine the percent of subjects whose estimated BG values are \> +/-15% different than meter BG values when samples have BG \>=100 mg/dL or \> +/- 15 mg/dL different than meter BG values when samples have BG \<100 mg/dL, as measured by fingerstick CONTOUR®.
Time frame: 1 visit 15-20 minutes
Population: Three subjects were excluded from analyses due to inconsistencies in responses to inclusion/exclusion questions(297-3=294). Eight subjects were excluded from BG analyses because they did not have both an estimated BG value and a meter result (294-8=286)
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| People With Type 2 Diabetes | Percent of Subjects Outside a Second Specified Blood Glucose (BG) Range -Estimated Versus Measured Blood Glucose | 57.69 percentage of subjects |