Table 1. Characteristics of the 40 Subjects with Type 1 Diabetes.
| Total Cohort (N = 40) | Insulin Pump Subgroup (n = 26) | MDI Subgroup (n = 14) | |
|---|---|---|---|
| Clinical Characteristics | |||
| Male Sex, N (%) | 20 (50) | 13 (50) | 7 (50) |
| Age | 24.3 ± 5.1 | 24.8 ± 5.3 | 23.2 ± 4.6 |
| Diabetes Duration | |||
| >1 to 5 years | 4 | 2 | 2 |
| >5 years | 36 | 24 | 12 |
| Total Daily Insulin (units) | 54.7 ± 20.4 | 53.9 ± 19.8 | 56.3 ± 22.3 |
| BMI (kg/m2) | 24.5 ± 3.2 | 24.7 ± 3.6 | 24.2 ± 2.3 |
| Glycemic Measures* | |||
| Baseline Fasting Glucose (mg/dL) | 180.18 ± 87.66 | 164.88 ± 66.24 | 208.62 ± 115.2 |
| HBA1c (%) | |||
| Baseline | 8.03 ± 0.91 | 7.95 ± 0.83 | 8.16 ± 1.06 |
| End-of-treatment | 7.62 ± 0.15 † | 7.52 ± 0.16 † | 7.81 ± 0.31 |
| Post-treatment | 7.74 ± 0.16 † | 7.57 ± 0.16 † | 8.05 ± 0.34 |
| Glycemic Exposure (mg/dL)*hr | |||
| Baseline | 153.7 ± 25.4 | 156.3 ± 26.1 | 148.3 ± 23.9 |
| End-of-treatment | 149.0 ± 30.2 | 151.6 ± 26.9 | 143.8 ± 36.7 |
| Post-treatment | 164.1 ± 29.5 † | 162.9 ± 28.4 | 166.5 ± 32.6 † |
| Glycemic Variability (mg/dL) | |||
| Baseline | 83.1 ± 18.9 | 81.3 ± 17.8 | 86.7 ± 21.2 |
| End-of-treatment | 75.6 ± 28.6 | 75.1 ± 32.5 | 76.5 ± 19.7 |
| Post-treatment | 89.3 ± 19.3 † | 89.2 ± 21.6 † | 89.4 ± 14.7 |
| Glycemic Stability (mg/dL/hr) | |||
| Baseline | 10.8 ± 3.6 | 10.1 ± 3.1 | 12.2 ± 4.2 |
| End-of-treatment | 10.3 ± 4.5 | 10.0 ± 4.6 | 11.0 ± 4.3 |
| Post-treatment | 11.8 ± 3.7 | 11.5 ± 3.8 † | 12.3 ± 3.6 |
| Percentage of Time Spent 70-140mg/dL | |||
| Baseline | 40.2 ± 11.9 | 39.9 ± 13.8 | 40.9 ± 7.1 |
| End-of-treatment | 43.1 ± 13.5 | 43.9 ± 14.2 | 41.7 ± 12.2 |
| Post-treatment | 35.0 ± 12.1 | 36.4 ± 12.5 | 32.2 ± 11.2 † |
| Percentage of Time Spent >180mg/dL | |||
| Baseline | 34.1 ± 14.4 | 34.8 ± 16.0 | 32.6 ± 10.8 |
| End-of-treatment | 29.1 ± 14.9 | 29.8 ± 15.5 | 27.8 ± 14.3 |
| Post-treatment | 39.8 ± 15.7 | 38.9 ± 15.0 | 41.5 ± 17.4 † |
| Percentage of Time Spent <70mg/dL | |||
| Baseline | 5.0 ± 4.6 | 3.7 ± 2.9 | 7.6 ± 6.2 |
| End-of-treatment | 5.2 ± 6.4 | 3.3 ± 2.8 | 9.1 ± 9.4 |
| Post-treatment | 5.0 ± 4.9 | 4.0 ± 3.5 | 6.9 ± 6.5 |
Unless otherwise indicated all data are presented as mean ± SD.
Comparisons are made between end-of-treatment and baseline, or post-treatment and baseline within the Total Cohort and within each of the Insulin Pump and MDI subgroups.
* For the analysis of AGP parameters, evaluable data from baseline and end of treatment periods was available for 39 subjects. The post-treatment period included 38 evaluable subjects due to missing data from a subject in the MDI group.
† Indicates p<0.05 for comparison with the corresponding baseline value. Specifically: HbA1c end-of-treatment comparison with baseline for the Total Cohort, p<0.0001; post-treatment comparison with baseline for the Total Cohort, p = 0.007; end-of-treatment comparison with baseline for the Pump Group, p<0.0001; post-treatment comparison with baseline for the Pump Group, p = 0.0007. Glycemic Exposure post-treatment comparison with baseline for the Total Cohort, p = 0.02; post-treatment comparison with baseline for the MDI Group, p = 0.01. Glycemic Variability post-treatment comparison with baseline for the Total Cohort, p = 0.04; post-treatment comparison with baseline for the Pump Group, p = 0.047. Glycemic Stability post-treatment comparison with baseline for the Pump Group, p = 0.03. Percentage of Time Spent >180mg/dL post-treatment comparison with baseline for the MDI Group, p = 0.04. Percentage of Time Spent 70-140mg/dL post-treatment comparison with baseline for the MDI Group, p = 0.003.