Table 2.
Change per treatment mode and overall CIPII treatment effect
| Change with treatment mode |
Treatment effect adjusted for treatment order* | P | ||
|---|---|---|---|---|
| CIPII | Subcutaneous insulin | |||
| n | 23 | 23 | ||
| A1C (%) | −0.73 ± 1.25 | 0.05 ± 0.54 | −0.76 (−1.41 to −0.11) | 0.03 |
| Hypoglycemia grade 1 (n/week)†‡ | −0.64 ± 2.11 | −0.15 ± 1.33 | −0.50 (−1.16 to 0.17) | 0.13 |
| Hypoglycemia grade 2 (n/week) †‡ | −0.49 ± 1.68 | −0.07 ± 1.07 | −0.43 (−0.89 to 0.04) | 0.07 |
| Time spent in glucose range (%)†§ | ||||
| Hypoglycemia | −3.0 ± 6.2 | −1.3 ± 8.3 | −2.0 (−5.4 to 1.3) | 0.22 |
| Euglycemia | 7.8 ± 18.9 | −4.1 ± 17.2 | 10.9 (4.6 to 17.3) | 0.002 |
| Hyperglycemia | −4.7 ± 22.0 | 5.4 ± 19.5 | −8.9 (−16.7 to −1.2) | 0.03 |
| Insulin dose (IU/day)† | 0.5 (−6.8 to −5.0) | 0.3 (−6.7 to −5.8) | 0.57 | |
| Systolic blood pressure (mmHg)† | 0.4 ± 17.6 | −4.0 ± 16.3 | 3.0 (−2.6 to 8.7) | 0.28 |
| BMI (kg/m2)† | −0.4 ± 1.2 | 0.2 ± 0.9 | −0.4 (−0.9 to 0.2) | 0.18 |
Data for change are mean ± SD or median (interquartile range).
*Data for treatment effect are mean differences (95% CI) adjusted for treatment order calculated using the Hills-Armitage method (14).
†Change from baseline is reported.
‡Hypoglycemia grade 1 is defined as a blood glucose value <4.0 mmol/l; hypoglycemia grade 2 is defined as a blood glucose value <3.5 mmol/l.
§Time spent in hypoglycemia is defined as the percentage of CGM recordings of <4.0 mmol/l, time spent in euglycemia is defined as the percentage of CGM recordings between 4.0 and 10.0 mmol/l, and time spent in hyperglycemia is defined as the percentage of CGM recordings >10.0 mmol/l.