NCT01453413

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
297

participants targeted

Target at P75+ for not_applicable diabetes

Timeline
Completed

Started Oct 2011

Shorter than P25 for not_applicable diabetes

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 30, 2011

Completed
1 day until next milestone

Study Start

First participant enrolled

October 1, 2011

Completed
16 days until next milestone

First Posted

Study publicly available on registry

October 17, 2011

Completed
15 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2011

Completed
1.1 years until next milestone

Results Posted

Study results publicly available

December 17, 2012

Completed
Last Updated

February 25, 2013

Status Verified

February 1, 2013

Enrollment Period

1 month

First QC Date

September 30, 2011

Results QC Date

November 12, 2012

Last Update Submit

February 21, 2013

Conditions

Diabetes

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (1)

  • Percent of Subjects Outside a Second Specified Blood Glucose (BG) Range -Estimated Versus Measured Blood Glucose

    1 visit 15-20 minutes

Study Arms (1)

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.

Other: Blood Glucose meter

Interventions

Blood Glucose meterOTHER

Staff tested subject Blood Glucose using a Blood Glucose meter.

Also known as: Contour® Blood Glucose Meter
People with type 2 diabetes

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Males and females, 18 years of age and above
  • Type 2 diabetes
  • Able to speak, read, and understand English
  • Willing to complete all study procedures

You may not qualify if:

  • Type 1 diabetes
  • Currently a user of continuous glucose monitoring system
  • Currently pregnant
  • Hemophilia or any other bleeding disorder
  • Employee of competitive medical device company
  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

TCOYD at San Diego Convention Center

San Diego, California, 92101, United States

Location

TCOYD Conference at Tampa Convention Center

Tampa, Florida, 33602-5331, United States

Location

Related Publications (1)

  • 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.

    PMID: 24889281DERIVED

MeSH Terms

Conditions

Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Results Point of Contact

Title
Dr. Steven Edelman, MD
Organization
Taking Control of Your Diabetes
svedelman@vapop.ucsd.edu
858-755-5683

Study Officials

  • Steven Edelman, MD

    Founder TCOYD

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
GT60
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 30, 2011

First Posted

October 17, 2011

Study Start

October 1, 2011

Primary Completion

November 1, 2011

Study Completion

November 1, 2011

Last Updated

February 25, 2013

Results First Posted

December 17, 2012

Record last verified: 2013-02

Locations

US(2)