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

Diabetes Mellitus Clinical Trial

Official title:

Protocol #TS05-066 Clinical Evaluation of the Accuracy of the FreeStyle Navigator Continuous Glucose Monitoring System

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00920881
• Other study ID #: TS05-066
• Status: Completed
• Phase: N/A
• First received: June 11, 2009
• Last updated: June 11, 2009
• Start date: November 2005
• Est. completion date: December 2005

Study information

• Verified date: June 2009
• Source: Abbott Diabetes Care
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 58
• Est. completion date: December 2005
• Est. primary completion date: December 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Diabetes Mellitus

Intervention

Device:
• FreeStyle Navigator Continuous Glucose Monitoring System
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.

Locations

Country	Name	City	State
United States	Ranier Clinical Research	Renton	Washington
United States	Diabetes & Glandular Disease Clinic	San Antonio	Texas
United States	Diablo Clinical Research	Walnut Creek	California

Sponsors (1)

Lead Sponsor	Collaborator
Abbott Diabetes Care

Country where clinical trial is conducted

United States, 

References & Publications (2)

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. — View Citation

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. Ep — View Citation