Trial Outcomes & Findings for Blood Glucose Testing and You (NCT NCT01453413)

Results Overview

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®.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

297 participants

Primary outcome timeframe

1 visit 15-20 minutes

Results posted on

2013-02-25

Participant Flow

Participant milestones

Participant milestones
Measure	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
Overall Study STARTED	297
Overall Study COMPLETED	297
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Blood Glucose Testing and You

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	People With Type 2 Diabetes n=294 Participants 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.
Age Continuous	59 years n=5 Participants
Sex: Female, Male Female	177 Participants n=5 Participants
Sex: Female, Male Male	117 Participants n=5 Participants
Region of Enrollment United States	294 participants n=5 Participants

PRIMARY outcome

Timeframe: 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)

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®.

Outcome measures

Outcome measures
Measure	People With Type 2 Diabetes n=286 Participants 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.
Percent of Subjects Outside Specified Blood Glucose (BG) Range -Estimated Versus Measured Blood Glucose	45.80 percentage of subjects Interval 40.12 to 51.6

SECONDARY outcome

Timeframe: 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)

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®.

Outcome measures

Outcome measures
Measure	People With Type 2 Diabetes n=286 Participants 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.
Percent of Subjects Outside a Second Specified Blood Glucose (BG) Range -Estimated Versus Measured Blood Glucose	57.69 percentage of subjects Interval 51.9 to 63.28

Adverse Events

People With Type 2 Diabetes

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	People With Type 2 Diabetes n=297 participants at risk Perceived BG value versus measured BG for people with type 2 diabetes who are in attendance at a diabetes conference
Endocrine disorders hypoglycemia	1.0% 3/297 • Number of events 3

Additional Information

Dr. Steven Edelman, MD

Taking Control of Your Diabetes

Phone: 858-755-5683

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: GT60