Performance of a New Glucose Meter System in Children and Young Adults

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Bayer HealthCare, Diabetes Care
ClinicalTrials.gov Identifier:
NCT00985257
First received: September 24, 2009
Last updated: January 26, 2012
Last verified: January 2012
  Purpose

The purpose of this study is to evaluate the performance of a new blood glucose meter in the hands of children, teens, young adults.


Condition Intervention
Diabetes
Device: DIDGET (Investigational Blood Glucose Monitoring System)

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Performance of the DIDGET Blood Glucose Monitoring System in Children and Young Adults

Resource links provided by NLM:


Further study details as provided by Bayer HealthCare, Diabetes Care:

Primary Outcome Measures:
  • Percent of Blood Glucose (BG) Results Within +/-15mg/dL or +/-20% of Laboratory Glucose Method [ Time Frame: 1-2 hours ] [ Designated as safety issue: No ]
    Subjects with diabetes and healthcare professionals (HCPs) used a new blood glucose monitoring system (BGMS) with subject blood. BGM results were compared to a lab glucose method - Yellow Springs Instrument (YSI) Analyzer. Duplicate BG results were used to calculate the number of BG results within +/-15mg/dL (for reference BG results <75mg/dL) or +/- 20% (for reference BG values >/=75mg/dL) of the reference method results.


Enrollment: 123
Study Start Date: September 2009
Study Completion Date: October 2009
Primary Completion Date: October 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Subjects with diabetes
Subjects with diabetes (or parents/guardians, if applicable)and healthcare professionals (HCPs) use a new blood glucose monitoring system. Subjects were 4 to 24 years of age with type 1 and type 2 diabetes.
Device: DIDGET (Investigational Blood Glucose Monitoring System)
Subjects with diabetes (with parent/guardian assistance, if applicable)and health care professionals (HCPs) each performed duplicate Blood Glucose (BG) tests from the subject's capillary blood on the DIDGET. To test the full range of glucose concentrations, a venipuncture was performed on some subjects to obtain enough blood for modifying (spiking or glycolyzing) to the extreme glucose concentrations. Results were compared to a laboratory glucose method - the Yellow Springs Instrument (YSI) Analyzer.

  Eligibility

Ages Eligible for Study:   4 Years to 24 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Type 1 or Type 2 diabetes
  • Age 4 to 24 years
  • Routinely performs blood glucose testing at home
  • If age 18 or older at time informed consent is signed, subject must be able to speak, read, and understand English.
  • If younger than age 18, subject's parent/guardian must be able to speak, read, and understand English, and is able to provide appropriate supervision.
  • Is willing to complete all study procedures, with or without parent / guardian supervision, if appropriate

Exclusion Criteria:

  • Currently pregnant
  • Hemophilia or any other bleeding disorder
  • Taking prescription anticoagulants (such as Warfarin or heparin) or has clotting problems that may prolong bleeding. Taking Plavix or aspirin daily is not excluded
  • Infection with a blood borne pathogen (e.g., HIV, hepatitis)
  • Subject or parent/guardian is employee of competitive medical device company
  • Cognitive disorder or other condition, which in the opinion of the investigator, would put the person at risk or seriously compromise the integrity of the study
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00985257

Locations
United States, California
AMCR Institute
Escondido, California, United States, 92026
United States, Florida
Larry C. Deeb, MD PA
Tallahassee, Florida, United States, 32308
Sponsors and Collaborators
Bayer HealthCare, Diabetes Care
Investigators
Principal Investigator: Timothy Bailey, MD AMCR Institute
Principal Investigator: Larry C Deeb, MD PA Larry C. Deeb, MD PA
  More Information

No publications provided

Responsible Party: Bayer HealthCare, Diabetes Care
ClinicalTrials.gov Identifier: NCT00985257     History of Changes
Other Study ID Numbers: CTD-2009-35
Study First Received: September 24, 2009
Results First Received: April 6, 2010
Last Updated: January 26, 2012
Health Authority: United States: Institutional Review Board

ClinicalTrials.gov processed this record on July 24, 2014