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

Diabetes Clinical Trial

Official title:

Performance of the DIDGET Blood Glucose Monitoring System in Children and Young Adults

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00985257
• Other study ID #: CTD-2009-35
• Status: Completed
• Phase: N/A
• First received: September 24, 2009
• Last updated: January 29, 2016
• Start date: September 2009
• Est. completion date: October 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 of a new blood glucose meter in the hands of children, teens, young adults.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 123
• Est. completion date: October 2009
• Est. primary completion date: October 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 4 Years to 24 Years

Eligibility

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

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

Related Conditions & MeSH terms

• Diabetes

Intervention

Device:
• DIDGET (Investigational Blood Glucose Monitoring System)
Subjects with diabetes (with parent/guardian assistance, if applicable)and health care professionals (HCPs) each performed duplicate Blood Glucose (BG) tests from the subject's capillary blood on the DIDGET. To test the full range of glucose concentrations, a venipuncture was performed on some subjects to obtain enough blood for modifying (spiking or glycolyzing) to the extreme glucose concentrations. Results were compared to a laboratory glucose method - the Yellow Springs Instrument (YSI) Analyzer.

Locations

Country	Name	City	State
United States	AMCR Institute	Escondido	California
United States	Larry C. Deeb, MD PA	Tallahassee	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Ascensia Diabetes Care

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percent of Blood Glucose (BG) Results Within +/-15mg/dL or +/-20% of Laboratory Glucose Method	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.	1-2 hours	No