Meal consumption and insulin therapy during baseline and follow-up periods in both study groups
| Control group N=65 | rtCGM group N=70 | Adjusted between-group difference (95% CI) | P value | |||||
| n | Baseline | Follow-up | n | Baseline | Follow-up | |||
| Number of meals (n/day) | 63 | 4.4±1.3 | 4.1±1.3 | 64 | 4.3±1.2 | 4.2±1.3 | 0.3 (−0.1 to 0.6) | 0.101 |
| Estimated carbohydrates (g/day) | 53 | 182.9±63.8 | 177.5±59.9 | 57 | 173.8±65.1 | 168.0±65.0 | −2.0 (−17.1 to 13.1) | 0.793 |
| Insulin to carbohydrate ratio (U/g) | 54 | 0.14±0.07 | 0.14±0.07 | 57 | 0.16±0.12 | 0.16±0.14 | 0.00 (−0.01 to 0.02) | 0.717 |
| Rescue carbohydrate intake (n/day) | 62 | 1.1±0.8 | 0.9±0.8 | 66 | 0.8±0.6 | 1.0±0.8 | 0.3 (0.1 to 0.5) | 0.005 |
| Rescue carbohydrates (g/day) | 46 | 26.0±26.1 | 21.6±25.3 | 56 | 18.2±14.9 | 19.8±15.9 | 1.7 (−4.6 to 7.9) | 0.600 |
| Portion size rescue carbohydrates (g/intake) | 41 | 22.3±9.5 | 25.0±15.8 | 47 | 21.5±10.1 | 19.4±7.8 | −4.8 (−9.3 to −0.3) | 0.038 |
| Rescue threshold (mg/dL (mmol/L)) | 57 | 70.8±12.6 (3.9±0.7) | 70.9±14.1 (3.9±0.8) | 57 | 70.5±12.9 (3.9±0.7) | 78.8±14.2 (4.4±0.8) | 7.6 (2.4 to 12.8) (0.4 (0.1 to 0.7)) | 0.005 |
| Total daily insulin dose (U/day) | 61 | 48.8±24.2 | 48.8±22.9 | 62 | 52.8±40.7 | 52.7±46.3 | 0.4 (−3.5 to 4.4) | 0.830 |
| Basal dose (U/day) | 61 | 20.5±10.5 | 21.1±11.3 | 64 | 22.6±17.2 | 21.9±16.1 | −1.2 (−3.1 to 0.7) | 0.215 |
| Number of basal insulin injections (n/day) | 61 | 1.3±0.5 | 1.3±0.5 | 64 | 1.4±0.6 | 1.4±0.6 | 0.0 (−0.1 to 0.1) | 0.755 |
| Bolus dose (U/day) | 63 | 28.5±17.7 | 28.0±15.3 | 65 | 30.3±25.1 | 30.7±31.7 | 1.1 (−2.4 to 4.7) | 0.523 |
| Number of bolus insulin injections (n/day) | 64 | 4.0±0.9 | 3.8±0.9 | 66 | 4.0±1.0 | 4.0±0.9 | 0.1 (−0.1 to 0.4) | 0.221 |
| Correction factor (mg/dL/U (mmol/L/U)) | 58 | 39.7±22.7 (2.2±1.3) | 39.4±19.6 (2.2±1.1) | 54 | 43.4±21.0 (2.4±1.2) | 43.8±26.7 (2.4±1.5) | 2.7 (−4.2 to 9.5) (0.1 (−0.2 to 0.5)) | 0.442 |
Data are mean±SD. P values are based on covariance analysis using the randomization group as independent variable and the baseline values as well as intraindividual dispersion (number of contribution events per day and coefficient of variation between analyzed days) as covariates.
rtCGM, real-time continuous glucose monitoring.