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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| People with type 2 diabetes | Other | 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 a Blood Glucose meter, subjects were informed of their BG value. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Blood Glucose meter | Other | Staff tested subject Blood Glucose using a Blood Glucose meter. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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®. | 1 visit 15-20 minutes |
| Measure | Description | Time Frame |
|---|---|---|
| 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®. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Steven Edelman, MD | Founder TCOYD | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| TCOYD at San Diego Convention Center | San Diego | California | 92101 | United States | ||
| TCOYD Conference at Tampa Convention Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24889281 | Derived | Pettus J, Stenger P, Schachner HC, Dunne N, Parkes JL, Pardo S, Edelman SV. Testing versus guessing blood glucose values: impact on self-care behaviors in type 2 diabetes. Curr Med Res Opin. 2014 Sep;30(9):1795-802. doi: 10.1185/03007995.2014.929097. Epub 2014 Jun 30. |
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| ID | Title | Description |
|---|---|---|
| FG000 | People With Type 2 Diabetes | Perceived BG value versus measured BG for people with type 2 diabetes who are in attendance at a diabetes conference |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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®. | 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) | Posted | Number | 95% Confidence Interval | percentage of subjects | 1 visit 15-20 minutes |
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | People With Type 2 Diabetes | Perceived BG value versus measured BG for people with type 2 diabetes who are in attendance at a diabetes conference |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| hypoglycemia | Endocrine disorders | Non-systematic Assessment | Non-serious, mild, anticipated, Not device related |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Steven Edelman, MD | Taking Control of Your Diabetes | 858-755-5683 | svedelman@vapop.ucsd.edu |
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| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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| 1 visit 15-20 minutes |
| Tampa |
| Florida |
| 33602-5331 |
| United States |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| 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®. | 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) | Posted | Number | 95% Confidence Interval | percentage of subjects | 1 visit 15-20 minutes |
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| 0 |
| 297 |
| 3 |
| 297 |
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