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

Ascensia Diabetes Care

Status: Completed

Conditions: Diabetes

Treatments: Device: DIDGET (Investigational Blood Glucose Monitoring System)

Study type: Interventional

Funder types: Industry

Identifiers

NCT00985257

CTD-2009-35

Details and patient eligibility

About

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

Enrollment: 123 patients

Sex: All

Ages: 4 to 24 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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123 participants in 1 patient group

Subjects with diabetes

Other group

Description:

Subjects with diabetes (or parents/guardians, if applicable)and healthcare professionals (HCPs) use a new blood glucose monitoring system. Subjects were 4 to 24 years of age with type 1 and type 2 diabetes.

Treatment:

Device: DIDGET (Investigational Blood Glucose Monitoring System)