Navigator II Continuous Glucose Monitor Home Use Study

NCT01455064 | Completed Results

• 1 other identifier: ADC11-106
• Study Type: observational
• Target: 31
• Locations: 1 country
• Sites: 2

Brief Summary

This research study will test a new investigational continuous glucose monitoring system (System). The purpose of this study is to find out about the performance of the System in a home use environment over a 15 day period, in people with diabetes.

Conditions

Diabetes

Outcome Measures

Primary Outcomes (1)

• Clarke Error Grid Analysis

  Percentage of CGM results in the clinically accurate Zone A and percentage of CGM results in the clinically acceptable Zones A and B of the Clarke Error Grid versus blood glucose reference.

  15 days sensor wear

Study Arms (1)

Type 1 or 2 diabetes, MDI or pump

Device: FreeStyle Navigator II Continuous Glucose Monitoring System

Interventions

FreeStyle Navigator II Continuous Glucose Monitoring System DEVICE

This is not an interventional study. Subjects must maintain their own diabetes treatment regimen throughout the study duration

Type 1 or 2 diabetes, MDI or pump

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

Patients with type 1 or 2 diabetes requiring multiple daily insulin injections or using an insulin pump

You may qualify if:

• The subject must:
• Have type 1 or 2 diabetes for at least 2 years prior to enrollment.
• Require insulin therapy administered through an insulin pump or multiple daily injections (MDI) for at least 6 months prior to enrollment.
• Be at least 18 years of age.
• Be able to read and understand English.
• In the investigator's opinion, be able to follow the instructions provided to him/her by the study site and perform all study tasks as specified by the protocol.
• Be available for all study visits.
• Be willing to provide written signed and dated informed consent.

You may not qualify if:

• The subject must not:
• Be pregnant or likely to become pregnant during the study duration.
• Have skin abnormalities at the insertion sites.
• Have known allergy to medical grade adhesive or skin disinfectant.
• Be using a continuous glucose monitor currently or within the past 6 months
• Have a concomitant medical condition which, in the opinion of the investigator, could interfere with the study or present a risk to the safety or welfare of the subject.
• Be participating in another clinical trial.

Sponsors & Collaborators

• Abbott Diabetes Care: lead

Study Sites (2)

Atlanta Diabetes Associates

Atlanta, Georgia, 30309, United States

Location

Southwest Clinical Research Center

Santa Fe, New Mexico, 87505, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus

Condition Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Shridhara A. Karinka, Ph.D., Director of Clinical Affairs
• Organization: Abbott Diabetes Care

SHRIDHARA.ALVA@ABBOTT.COM

510-749-6393

Study Officials

• Shridhara A Karinka, Ph.D.

  Abbott Diabetes Care

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: GT60
• Restrictive Agreement: Yes

Study Design

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

Study Record Dates

• First Submitted: October 15, 2011
• First Posted: October 19, 2011
• Study Start: October 1, 2011
• Primary Completion: December 1, 2011
• Study Completion: January 1, 2012
• Last Updated: July 22, 2013
• Results First Posted: July 22, 2013

Record last verified: 2013-05

Locations

US (2)