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

Not Applicable

Completed

• Conditions: Diabetes

• Registration Number: NCT00985257
• Lead Sponsor: Ascensia Diabetes Care

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2009-09
• Study First Submitted: 2009-09-24
• Study First Submitted QC: 2009-09-25
• Study First Posted: 2009-09-28
• Primary Completion: 2009-10
• Study Completion: 2009-10
• Results First Submitted: 2010-04-06
• Results First Submitted QC: 2010-10-07
• Results First Posted: 2010-11-02
• Status Verified: 2016-01
• Last Update Submitted: 2016-01-29
• Last Update Posted: 2016-02-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 123

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Percent of Blood Glucose (BG) Results Within +/-15mg/dL or +/-20% of Laboratory Glucose Method	1-2 hours	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.

Trial Locations

Locations (2)

AMCR Institute; 🇺🇸 Escondido, California, United States

Larry C. Deeb, MD PA; 🇺🇸 Tallahassee, Florida, United States