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

Ascensia Diabetes Care

Status: Completed

Conditions: Diabetes

Treatments: Device: Investigational Blood Glucose Monitoring System

Study type: Interventional

Funder types: Industry

Identifiers

NCT00803777

CTD-2008-23

Details and patient eligibility

About

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

Enrollment: 147 patients

Sex: All

Ages: 4 to 24 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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147 participants in 1 patient group

Intended Users of the Monitoring System

Experimental group

Description:

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.

Treatment:

Device: Investigational Blood Glucose Monitoring System