Clinical Evaluation of the Accuracy of the FreeStyle Navigator Continuous Glucose Monitoring System

NCT00920881 | Completed

• 1 other identifier: TS05-066
• Study Type: observational
• Target: 58
• Locations: 1 country
• Sites: 3

Brief Summary

To evaluate the clinical accuracy of the FreeStyle Navigator Continuous Glucose Monitoring System with respect to a reference standard.

Conditions

Diabetes Mellitus

Keywords

Continuous glucose monitoring; Accuracy; Continuous glucose-error grid analysis

Study Arms (1)

Diabetes

Device: FreeStyle Navigator Continuous Glucose Monitoring System

Interventions

FreeStyle Navigator Continuous Glucose Monitoring System DEVICE

Subjects wore 2 Navigator sensors for approximately 122 hours. Subjects and clinical staff were masked to continuous glucose data. During the time the subjects wore the continuous sensor, they were instructed to continue with their current diabetes management plan. Subjects stayed at the clinic for approximately 50 hours during the study period. While in the clinic, venous blood samples were collected every 15 minutes to determine whole blood reference glucose concentrations using the Yellow Springs Instrument. Subjects were also asked to obtain up to 50 FreeStyle finger blood glucose measurements using the system in the Navigator receiver for comparative analysis and system calibration. This was not a treatment study.

Diabetes

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Subjects recruited from clinical research centers which specialize in diabetes-related therapies.

You may qualify if:

• History consistent with type 1 diabetes
• At least 18 years of age
• Available and capable of following the protocol instructions provided by the healthcare professional
• Signed and dated informed consent form

You may not qualify if:

• Pregnancy
• Type 2, gestational, or secondary diabetes
• Known allergy to medical grade adhesives
• Skin abnormalities at the insertion sites that would confound the assessment of the effect of the device on the skin
• Seizure disorder
• Myocardial ischemia
• History of stroke
• Severe hypoglycemia unawareness
• Other concomitant medical conditions that in the opinion of the investigator, would affect the evaluation of device performance and/or safety

Sponsors & Collaborators

• Abbott Diabetes Care: lead

Study Sites (3)

Diablo Clinical Research

Walnut Creek, California, 94598, United States

Location

Diabetes & Glandular Disease Clinic

San Antonio, Texas, 78229, United States

Location

Ranier Clinical Research

Renton, Washington, 98055, United States

Location

Related Publications (2)

• Weinstein RL, Schwartz SL, Brazg RL, Bugler JR, Peyser TA, McGarraugh GV. Accuracy of the 5-day FreeStyle Navigator Continuous Glucose Monitoring System: comparison with frequent laboratory reference measurements. Diabetes Care. 2007 May;30(5):1125-30. doi: 10.2337/dc06-1602. Epub 2007 Mar 2.

  PMID: 17337488 RESULT

• McGarraugh G, Bergenstal R. Detection of hypoglycemia with continuous interstitial and traditional blood glucose monitoring using the FreeStyle Navigator Continuous Glucose Monitoring System. Diabetes Technol Ther. 2009 Mar;11(3):145-50. doi: 10.1089/dia.2008.0047.

  PMID: 19216686 RESULT

MeSH Terms

Conditions

Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Joe Bugler

  Abbott Diabetes Care

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: June 11, 2009
• First Posted: June 15, 2009
• Study Start: November 1, 2005
• Primary Completion: December 1, 2005
• Study Completion: December 1, 2005
• Last Updated: June 15, 2009

Record last verified: 2009-06

Locations

US (3)