NCT01474317

Brief Summary

The purpose of this study is to demonstrate that untrained subjects who have diabetes can operate the Investigational Blood Glucose Monitoring System (BGMS) and obtain valid glucose results.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
226

participants targeted

Target at P50-P75 for not_applicable diabetes

Timeline
Completed

Started Nov 2011

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

Study Start

First participant enrolled

November 1, 2011

Completed
Same day 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
15 days until next milestone

First Submitted

Initial submission to the registry

November 16, 2011

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 18, 2011

Completed
1.1 years until next milestone

Results Posted

Study results publicly available

January 3, 2013

Completed
Last Updated

February 29, 2016

Status Verified

January 1, 2016

Enrollment Period

Same day

First QC Date

November 16, 2011

Results QC Date

November 30, 2012

Last Update Submit

January 29, 2016

Conditions

Diabetes

Outcome Measures

Primary Outcomes (1)

  • Percent of Self-Test Fingerstick Blood Glucose Results Within +/- 5to15mg/dL (<100mg/dL) or Within +/- 5to15% (>=100mg/dL) of Laboratory Glucose Method

    Untrained subjects with diabetes self-test fingerstick blood using an investigational 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 +/- 5to15mg/dL (\<100mg/dL YSI capillary plasma) or +/- 5to15% (\>=100mg/dL YSI capillary plasma). Site staff tested in parallel after subjects.

    1 hour

Secondary Outcomes (3)

  • Percent of Glucose Results From Alternative Site Testing (AST) of the Palm Within +/- 15mg/dL (<75mg/dL) or Within +/- 20% (>=75mg/dL) of Laboratory Glucose Method

    1 hour

  • Percent of Venous Blood Glucose Results Within +/- 5to15mg/dL (<75mg/dL) or Within +/- 5to20% (>=75mg/dL) of Laboratory Glucose Method

    1 hour

  • Number of Subjects Able to Perform Given Tasks Using Product Labeling for Instruction

    1 hour

Study Arms (1)

Intended Users of the Monitoring System

EXPERIMENTAL

Untrained subjects with diabetes use the G3 investigational blood glucose monitoring system.

Device: G3 Investigational Blood Glucose Monitoring System

Interventions

G3 Investigational Blood Glucose Monitoring SystemDEVICE

Untrained subjects with diabetes perform self Blood Glucose (BG) tests with capillary fingerstick blood and AST of the palm using the G3 meter and an investigational sensor. Study staff test subject venous blood and all BG results are compared to a reference laboratory glucose method. Untrained subjects utilize some additional features of the meter using the User Guide and provide feedback.

Intended Users of the Monitoring System

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 older
  • Type 1 or type 2 diabetes
  • Able to speak, read, and understand English
  • Willing to complete all study procedures

You may not qualify if:

  • Pregnancy
  • Hemophilia or any other bleeding disorder
  • Previously participated in a study using the G3 system
  • Working for a medical laboratory, hospital or other clinical setting that involves training on and clinical use of blood glucose monitors.
  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Consumer Product Testing Co.

Fairfield, New Jersey, 07004, United States

Location

Southwest Clinical Research Center

Santa Fe, New Mexico, 87505, 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
Jane Wallace
Organization
Ascensia Diabetes Care
jane.wallace@ascensia.com
574-257-3063

Study Officials

  • Robert Bernstein, MD, FACE

    Southwest Clinical Research Center

    PRINCIPAL INVESTIGATOR

  • Michael Caswell, PhD

    Consumer Product Testing Co.

    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
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 16, 2011

First Posted

November 18, 2011

Study Start

November 1, 2011

Primary Completion

November 1, 2011

Study Completion

November 1, 2011

Last Updated

February 29, 2016

Results First Posted

January 3, 2013

Record last verified: 2016-01

Locations

US(2)