NCT01575080

Brief Summary

The purpose of this study is to determine if untrained subjects who have diabetes can operate the Blood Glucose Monitoring System (BGMS) and obtain acceptable glucose results.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
102

participants targeted

Target at P50-P75 for not_applicable diabetes

Timeline
Completed

Started Apr 2012

Geographic Reach
1 country

1 active site

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

Study Start

First participant enrolled

April 1, 2012

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2012

Completed
8 days until next milestone

First Submitted

Initial submission to the registry

April 9, 2012

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 11, 2012

Completed
1.2 years until next milestone

Results Posted

Study results publicly available

July 8, 2013

Completed
Last Updated

February 29, 2016

Status Verified

January 1, 2016

Enrollment Period

Same day

First QC Date

April 9, 2012

Results QC Date

April 26, 2013

Last Update Submit

January 29, 2016

Conditions

Diabetes

Outcome Measures

Primary Outcomes (1)

  • Number of Self-Test Fingerstick Blood Glucose Results Within +/- 15mg/dL (<100mg/dL) or Within +/- 15% (>=100mg/dL) of Laboratory Glucose Method

    Untrained subjects with diabetes self-test fingerstick blood using the Blood Glucose Monitoring System (BGMS). BGMS results are compared with capillary plasma BG results obtained with a Yellow Springs Instrument (YSI) Analyzer. YSI Analyzer BG results are used to calculate the number of BGMS results within +/- 15mg/dL (\<100mg/dL YSI capillary plasma) or +/- 15% (\>=100mg/dL YSI capillary plasma).

    1 hour

Secondary Outcomes (3)

  • Number of Self-Test Alternative Site (Palm) Blood Glucose Results Within +/- 15mg/dL (<100mg/dL) or Within +/- 15% (>=100mg/dL) of Laboratory Glucose Method

    1 hour

  • Number of Self-Test Alternative Site (Forearm) Blood Glucose Results Within +/- 15mg/dL (<100mg/dL) or Within +/- 15% (>=100mg/dL) of Laboratory Glucose Method

    1 hour

  • Number of Subject Responses That 'Agree' or 'Strongly Agree' With Questionnaire Statements

    1 hour

Study Arms (1)

Intended Users of the Monitoring System

EXPERIMENTAL

Untrained subjects with diabetes use Contour TS Blood Glucose Monitoring System.

Device: Contour TS Blood Glucose Monitoring System

Interventions

Contour TS Blood Glucose Monitoring SystemDEVICE

Untrained subjects with diabetes perform self Blood Glucose (BG) tests with capillary fingerstick blood and AST of the palm and forearm using the Contour TS Blood Glucose Monitoring System. All BG results are compared to a reference laboratory glucose method.

Intended Users of the Monitoring System

Eligibility Criteria

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

You may qualify if:

  • Have a diagnosis of diabetes
  • Be 18 years of age or older
  • Be able to speak, read and understand English and understand the Informed Consent document.
  • Be willing to complete study procedures

You may not qualify if:

  • Pregnancy
  • Infections or skin disorders at the puncture site (at the discretion of the site professional staff).
  • Physical (dexterity), visual, or neurological impairments that would make the person unable to perform testing with the BGM (at the discretion of the site professional staff).
  • Previously participated in a blood glucose monitoring study using Contour TS system or use the Contour TS for personal use when monitoring blood glucose.
  • 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
  • Working for a medical laboratory, hospital or other clinical setting that involves training on and clinical use of blood glucose monitors

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Bayer HealthCare LLC, Diabetes Care

Mishawaka, Indiana, 46544, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Results Point of Contact

Title
Carmine Greene
Organization
Ascensia Diabetes Care
carmine.greene@ascensia.com
574-257-3040

Study Officials

  • David Simmons, MD

    Ascensia Diabetes Care

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

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

Study Record Dates

First Submitted

April 9, 2012

First Posted

April 11, 2012

Study Start

April 1, 2012

Primary Completion

April 1, 2012

Study Completion

April 1, 2012

Last Updated

February 29, 2016

Results First Posted

July 8, 2013

Record last verified: 2016-01

Locations

US(1)