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

Diabetes Clinical Trial

Official title:

In-Clinic and Home-Use Study of the AVATAR Blood Glucose Monitoring System in Children and Young Adults

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00803777
• Other study ID #: CTD-2008-23
• Status: Completed
• Phase: N/A
• First received: December 5, 2008
• Last updated: January 29, 2016
• Start date: December 2008
• Est. completion date: March 2009

Study information

• Verified date: January 2016
• Source: Ascensia Diabetes Care
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 147
• Est. completion date: March 2009
• Est. primary completion date: March 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 4 Years to 24 Years

Eligibility

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

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Diabetes

Intervention

Device:
• Investigational Blood Glucose Monitoring System
Subjects with diabetes used a new blood glucose monitoring system with capillary blood. Certain results were compared to a laboratory glucose method.

Locations

Country	Name	City	State
United States	Barbara Davis Center	Aurora	Colorado
United States	AMCR Institute	Escondido	California
United States	Hackensack University Medical Center	Hackensack	New Jersey
United States	Childrens Hospital Los Angeles	Los Angeles	California

Sponsors (1)

Lead Sponsor	Collaborator
Ascensia Diabetes Care

Country where clinical trial is conducted

United States, 

References & 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	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	No
Secondary	Numbers of BG Results in Zones of the Parkes Error Grid of Clinical Significance of Inaccuracies	The Parkes Error Grid, developed from a survey of 100 clinicians, plots combinations of BG meter measurements against reference method results. Each (x,y) point on the grid is within a risk category, assigned by the clinicians surveyed. Risk categories (increasing severity): ZoneA: No effect on clinical action; ZoneB: Altered clinical action or little/no effect on clinical outcome; ZoneC: Altered clinical action likely to effect clinical outcome; ZoneD: Altered clinical action could have significant medical risk; ZoneE: Altered clinical action could have dangerous consequences	1-2 hours	Yes
Secondary	Number of Participants Rated as <=2 (Labeling Comprehension)	Subjects or parents/guardians, as applicable, performed meter tasks after reading the User Guide and Quick Reference Guide. The study staff rated the participants on their success at performing the tasks as follows: Successful in performing tasks correctly without assistance; Successful after study staff prompted participant to review User Guide.; Successful after study staff assisted subject. (Similar to review of a specific function during a Customer Service call.); Subject did not perform task correctly and study staff intervention was required.	1-2 hours	No
Secondary	Average Within Replicate Coefficient of Variation CV (Precision)	The average Coefficient of Variation (CV) was computed by calculating the square of the CV for each pair of Blood Glucose (BG) self-test results, averaging this square value over the number of subjects included in the analysis, and then taking the square root.	1-2 hours	No