N/A
Completed N=31
Navigator II Continuous Glucose Monitor Home Use Study
Source: ClinicalTrials.gov NCT01455064 ↗Enrolled (actual)
31
Serious AEs
0.0%
Results posted
Jul 2013
Primary outcomePrimary: Clarke Error Grid Analysis — 83.0; 97.7 Percentage of Results
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Clarke Error Grid Analysis |
83.0; 97.7 | — |
Eligibility 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.
Data sourced from ClinicalTrials.gov (NCT01455064). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.