Clinical trial NCT00803777: In-Clinic and Home-Use Study of a New Blood Glucose Monitoring System
Official title: In-Clinic and Home-Use Study of the AVATAR Blood Glucose Monitoring System in Children and Young Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes
Lead sponsor: Ascensia Diabetes Care
Sponsor class: INDUSTRY
First posted: 2008-12-08
Enrollment: 147
Sex: ALL
Minimum age (years): 4
Maximum age (years): 24
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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


Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Number of Duplicate Capillary Results Within +/- 15mg/dL or +/- 20% of Laboratory Glucose Method
timeFrame: 1-2 hours
measure: Number of Duplicate Subject BGM Results Within +/- 15mg/dL or +/- 20% of Healthcare Professional Capillary Results
timeFrame: 1-2 hours
Secondary outcomes:
measure: Numbers of BG Results in Zones of the Parkes Error Grid of Clinical Significance of Inaccuracies
timeFrame: 1-2 hours
measure: Number of Participants Rated as <=2 (Labeling Comprehension)
timeFrame: 1-2 hours
measure: Average Within Replicate Coefficient of Variation CV (Precision)
timeFrame: 1-2 hours
Other outcomes:
Locations:
city: Escondido
country: United States
facility: AMCR Institute
state: California
city: Los Angeles
country: United States
facility: Childrens Hospital Los Angeles
state: California
city: Aurora
country: United States
facility: Barbara Davis Center
state: Colorado
city: Hackensack
country: United States
facility: Hackensack University Medical Center
state: New Jersey
Study officials:
affiliation: Hackensack Meridian Health
name: Javier Aisenberg, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Barbara Davis Center
name: Georgeanna Klingensmith, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Children's Hospital Los Angeles
name: Francine Kaufman, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: AMCR Institute
name: Timothy Bailey, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.