Navigator II Continuous Glucose Monitor Home Use Study
This study has been completed.
Sponsor:
Abbott Diabetes Care
Information provided by (Responsible Party):
Abbott Diabetes Care
ClinicalTrials.gov Identifier:
NCT01455064
First received: October 15, 2011
Last updated: August 15, 2012
Last verified: August 2012
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Diabetes |
Device: FreeStyle Navigator II Continuous Glucose Monitoring System |
| Study Type: | Observational |
| Study Design: | Observational Model: Cohort Time Perspective: Prospective |
| Official Title: | FreeStyle Navigator II Continuous Glucose Monitor Home Use Evaluation (FSNv2) |
Resource links provided by NLM:
Further study details as provided by Abbott Diabetes Care:
| Enrollment: | 31 |
| Study Start Date: | October 2011 |
| Study Completion Date: | January 2012 |
| Primary Completion Date: | December 2011 (Final data collection date for primary outcome measure) |
| Groups/Cohorts | Assigned Interventions |
|---|---|
| Type 1 or 2 diabetes, MDI or pump |
Device: FreeStyle Navigator II Continuous Glucose Monitoring System
This is not an interventional study. Subjects must maintain their own diabetes treatment regimen throughout the study duration
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Study Population
Patients with type 1 or 2 diabetes requiring multiple daily insulin injections or using an insulin pump
Criteria
Inclusion Criteria:
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.
Exclusion Criteria:
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.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01455064
Locations
| United States, Georgia | |
| Atlanta Diabetes Associates | |
| Atlanta, Georgia, United States, 30309 | |
| United States, New Mexico | |
| Southwest Clinical Research Center | |
| Santa Fe, New Mexico, United States, 87505 | |
Sponsors and Collaborators
Abbott Diabetes Care
Investigators
| Study Director: | Shridhara A Karinka, Ph.D. | Abbott Diabetes Care |
More Information
No publications provided
| Responsible Party: | Abbott Diabetes Care |
| ClinicalTrials.gov Identifier: | NCT01455064 History of Changes |
| Other Study ID Numbers: | ADC11-106 |
| Study First Received: | October 15, 2011 |
| Last Updated: | August 15, 2012 |
| Health Authority: | United States: Food and Drug Administration |
ClinicalTrials.gov processed this record on May 23, 2013