Table 1—

Major outcomes summary

BaselineWeeks 1–4Weeks 5–8Weeks 9–13P#P**
n272725*23*23
    Navigator use per week (h)
Wear153 ± 30107 ± 52114 ± 50107 ± 440.25
Glucose readings99 ± 4279 ± 4279 ± 4177 ± 410.12
    Meter tests per day4.9 ± 1.43.2 ± 1.72.9 ± 1.72.6 ± 1.60.16
n27242323
    A1C (%)
All subjects7.9 ± 1.07.4 ± 0.87.3 ± 0.90.004
Baseline <7.57.0 ± 0.56.7 ± 0.66.6 ± 0.50.03
Baseline >7.58.5 ± 0.77.8 ± 0.67.8 ± 0.70.02
n262623232223
    Mean glucose (mg/dl)
All subjects191 ± 34172 ± 18171 ± 23181 ± 310.250.05
Baseline <7.5170 ± 28162 ± 21161 ± 23159 ± 220.380.98
Baseline >7.5205 ± 31179 ± 13177 ± 22196 ± 290.490.03
    % Values 71–180 mg/dl
All subjects465555500.320.04
Baseline ≤7.5566261620.360.54
Baseline >7.5405152420.680.06
    Hypoglycemia (% values mg/dl)
≤704.43.34.03.40.360.75
≤602.61.61.91.60.270.63
≤501.390.760.930.790.300.52
≤400.850.400.570.420.330.36
    Hypoglycemia area§0.750.430.540.440.250.60
    Hyperglycemia (mg/dl)
Percent >180504241470.540.07
Percent >200423332380.450.06
Percent >250251415190.120.01
Percent >30011.24.55.07.30.070.008
Hyperglycemia area402526320.170.02
    Glucose lability
SD (mg/dl)746767690.120.04
MAGE (mg/dl)1471281261270.0010.66
Mean absolute rate of change0.840.810.770.790.160.44
  • Data are means ± SD or % unless otherwise indicated.

  • *

    * Three subjects dropped prior to 7-week visit, and another dropped prior to 13-week visit; one subject had baseline A1C ≤7.5%, and three subjects had baseline A1C >7.5%.

  • Subjects with <24 h of Navigator glucose readings were excluded from calculation of glycemic indices.

  • Number of subjects with at least 24 h of Navigator glucose readings for both time points.

  • §

    § Total area <70 mg/dl; reflects both percentage and severity of glucose values in the hypoglycemic range.

  • Total area above 180 mg/dl; reflects both percentage and severity of glucose values in the hyperglycemic range.

  • Rate of change calculated using consecutive Navigator readings 10 min apart (milligrams per deciliter per min).

  • #

    # Baseline vs. weeks 9–13.

  • **

    ** Weeks 1–4 vs. weeks 9–13. MAGE, mean amplitude of glycemic excursions.