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CompletedNCT01455064Updated Jul 22, 2013Results posted

Navigator II Continuous Glucose Monitor Home Use Study

An observational study in Diabetes, sponsored by Abbott Diabetes Care. Completed at 2 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2013-07-22.

Sponsored by Abbott Diabetes Care · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
31
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Diabetes
03

In context

Lead sponsor

Abbott Diabetes Care is the lead sponsor of 42 studies on the registry; 3 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
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

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

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.
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
31 participants (actual)

Groups and cohorts

  • Type 1 or 2 diabetes, MDI or pump

    Device: FreeStyle Navigator II Continuous Glucose Monitoring System

Interventions

  • DeviceFreeStyle Navigator II Continuous Glucose Monitoring System

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

06

What researchers measure

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.

    Time frame: 15 days sensor wear

07

Results

Posted Jul 22, 2013

Participant flow

Participants were recruited from within the patient population of two US diabetes clinical centers.

Participant flow — Overall Study
MilestoneObservational Group
Started31
Completed30
Not completed1

Outcome measures

PrimaryClarke 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.

Time frame:
15 days sensor wear
Reported as:
Number · Percentage of Results
Clarke Error Grid Analysis
Percentage of ResultsObservational Group
Percentage of results in Clarke Error Zone A83.0
Percentage_Results in Clarke Error Zones A&B97.7

Adverse events

Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Observational Group—0/31 (0%)4/31 (12.9%)
Most frequent other events
Most frequent other events
EventObservational Group
ScabbingSkin and subcutaneous tissue disorders2/31
Severe hypoglycemiaEndocrine disorders1/31
PruritusSkin and subcutaneous tissue disorders1/31
ErythemaSkin and subcutaneous tissue disorders1/31
LaryngitisGeneral disorders1/31
Ear infection in right earInfections and infestations1/31

Baseline characteristics

Age, Customized
Age, Customized(years)Observational Group
Mean48.4 (21 to 71)
Sex: Female, Male
Sex: Female, Male(Participants)Observational Group
Female15
Male16
Weight
Weight(kilograms)Observational Group
Mean90.4 (52.6 to 163.7)
Height
Height(meters)Observational Group
Mean1.70 (1.50 to 1.93)
Years since diagnosis
Years since diagnosis(years)Observational Group
Mean19.6 (5 to 47)
Daily total insulin dosage
Daily total insulin dosage(units)Observational Group
Mean72.8 (22 to 186)
Total number of injections per day
Total number of injections per day(injections (N subjects = 18))Observational Group
Mean3.6 (2 to 5)
08

Study locations

2 sites
  • Atlanta Diabetes Associates
    Atlanta, Georgia 30309, United States
  • Southwest Clinical Research Center
    Santa Fe, New Mexico 87505, United States
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 22, 2013, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT01455064
Lead sponsor
Abbott Diabetes Care
Responsible party
Sponsor
First posted
Oct 19, 2011
Start date
Oct 2011
Primary completion
Dec 2011
Completion
Jan 2012
Results posted
Jul 22, 2013
Last update
Jul 22, 2013

Study contacts

Shridhara A Karinka, Ph.D.
study director · Abbott Diabetes Care

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in May 2013. You cannot join it, but the record below documents what was studied.

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