In-Clinic and Home-Use Study of a New Blood Glucose Monitoring System

NCT00803777 | Completed Results

• 1 other identifier: CTD-2008-23
• Study Type: interventional
• Target: 147
• Locations: 1 country
• Sites: 4

Brief Summary

The purpose of this study is to evaluate the performance and acceptability of a new blood glucose meter.

Conditions

Diabetes

Outcome Measures

Primary Outcomes (2)

• Number of Duplicate Capillary Results Within +/- 15mg/dL or +/- 20% of Laboratory Glucose Method

  Subjects with diabetes (or parents/guardians) and healthcare professionals (HCPs) used a new blood glucose monitoring system (BGMS) with subject capillary blood. BGM results were compared to a lab glucose method - Yellow Springs Instrument (YSI) Analyzer. BG results were obtained in duplicate from subjects(158 BG results possible). The number of capillary results within +/- 15mg/dL (for reference blood glucose values \<75mg/dL) or +/- 20% (for reference blood glucose values \>/= 75mg/dL)of the reference results were calculated.

  1-2 hours

• Number of Duplicate Subject BGM Results Within +/- 15mg/dL or +/- 20% of Healthcare Professional Capillary Results

  Duplicate subject Blood Glucose Monitoring System (BGMS) results were compared to healthcare professional (HCP) BGMS results (possible number of results = 292). The number of Subject BGM results within +/- 15mg/dL (for reference BG values \<75mg/dL) and within +/- 20% (for reference BG values \>= 75mg/dL)of the HCP results was calculated.

  1-2 hours

Secondary Outcomes (3)

• Numbers of BG Results in Zones of the Parkes Error Grid of Clinical Significance of Inaccuracies

  1-2 hours

• Number of Participants Rated as <=2 (Labeling Comprehension)

  1-2 hours

• Average Within Replicate Coefficient of Variation CV (Precision)

  1-2 hours

Study Arms (1)

Intended Users of the Monitoring System

EXPERIMENTAL

Subjects with type 1 diabetes and healthcare professionals (HCP) used a new blood glucose monitoring system (BGMS) with subject capillary blood. Any subject under age 18 was accompanied by a parent or guardian, who assisted subject if applicable.

Device: Investigational Blood Glucose Monitoring System

Interventions

Investigational Blood Glucose Monitoring System DEVICE

Subjects with diabetes used a new blood glucose monitoring system with capillary blood. Certain results were compared to a laboratory glucose method.

Intended Users of the Monitoring System

Eligibility Criteria

• Age: 4 Years - 24 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Type 1 diabetes
• Age 4 to 24 years
• Routinely performs blood glucose testing at home, at least 2 times per day, for one month or more before enrollment
• Has used a handheld game system to play video games within a year of enrollment
• If above age 18, subject is able to speak, read, and understand English. If below age 18, subject's parent/guardian is able to speak, read, and understand English, and is able to provide appropriate supervision.
• Is willing to complete all study procedures, with appropriate parent/guardian supervision

You may not qualify if:

• 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

Sponsors & Collaborators

• Ascensia Diabetes Care: lead

Study Sites (4)

AMCR Institute

Escondido, California, 92026, United States

Location

Childrens Hospital Los Angeles

Los Angeles, California, 90027, United States

Location

Barbara Davis Center

Aurora, Colorado, 80045, United States

Location

Hackensack University Medical Center

Hackensack, New Jersey, 07601, United States

Location

Related Publications (1)

• Parkes JL, Slatin SL, Pardo S, Ginsberg BH. A new consensus error grid to evaluate the clinical significance of inaccuracies in the measurement of blood glucose. Diabetes Care. 2000 Aug;23(8):1143-8. doi: 10.2337/diacare.23.8.1143.

  PMID: 10937512 RESULT

MeSH Terms

Conditions

Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Results Point of Contact

• Title: Carmine Greene, Senior Clinical Research Scientist
• Organization: Ascensia Diabetes Care

carmine.greene@ascensia.com

574-257-3040

Study Officials

• Javier Aisenberg, MD

  Hackensack Meridian Health

  PRINCIPAL INVESTIGATOR

• Georgeanna Klingensmith, MD

  Barbara Davis Center

  PRINCIPAL INVESTIGATOR

• Francine Kaufman, MD

  Children's Hospital Los Angeles

  PRINCIPAL INVESTIGATOR

• Timothy Bailey, MD

  AMCR Institute

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• 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: December 5, 2008
• First Posted: December 8, 2008
• Study Start: December 1, 2008
• Primary Completion: March 1, 2009
• Study Completion: March 1, 2009
• Last Updated: February 29, 2016
• Results First Posted: June 16, 2010

Record last verified: 2016-01

Locations

US (4)