Variable and treatment groups | Baseline (5±0.1 days) | Intervention (6±0.1 days) | Change versus baseline | P value* versus baseline | P value† versus self-selected diet |
Preprandial (fasting) glucose (mg/dL) | |||||
Self-selected diet | 184.3±8.0 | 177.4±7.5 | −6.9±4.0 | 0.1193 | – |
DSNS Bkfst/AS | 186.3±12.8 | 182.0±12.2 | −4.4±5.4 | 0.2368 | 0.5713 |
DSNS Bkfst/PBS | 173.5±9.8 | 168.3±9.8 | −5.2±5.4 | 0.2714 | 0.7770 |
Breakfast, positive AUC (mg/dL*min, 0–120 min)‡ | |||||
Self-selected diet | 4237±514 | 3074±364 | −1162±422 | 0.0100 | – |
DSNS Bkfst/AS | 3258±529 | 1551±198 | −1708±496 | 0.0002 | 0.0083 |
DSNS Bkfst/PBS | 3928±596 | 1978±301 | −1950±582 | 0.0027 | 0.0686 |
Breakfast, adjusted peak value (mg/dL)‡ | |||||
Self-selected diet | 66.2±6.8 | 51.7±5.1 | −14±6 | 0.0195 | – |
DSNS Bkfst/AS | 52.7±7.2 | 27.9±3.1 | −25±7 | 0.0015 | 0.0025 |
DSNS Bkfst/PBS | 57.5±7.7 | 30.8±4.0 | −27±8 | 0.0023 | 0.0098 |
Daytime§ variability (MAGE, mg/dL) | |||||
Self-selected diet | 106.5±5.2 | 100.5±4.1 | −6.0±3.6 | 0.1018 | – |
DSNS Bkfst/AS | 104.5±6.5 | 98.6±6.9 | −5.9±4.6 | 0.2145 | 0.9586 |
DSNS Bkfst/PBS | 99.5±6.0 | 88.8±5.9 | −10.7±5.9 | 0.0803 | 0.3370 |
Nocturnal variability (MAGE, mg/dL) | |||||
Self-selected diet | 63.6±5.4 | 61.4±4.5 | −2.2±4.0 | 0.5936 | – |
DSNS Bkfst/AS | 70.8±8.8 | 59.5±7.2 | −11.3±4.5 | 0.0204 | 0.4623 |
DSNS Bkfst/PBS | 60.7±5.1 | 54.9±4.2 | −5.9±4.2 | 0.1793 | 0.7445 |
*Paired t-test or signed-rank test if a variable was declared non-normal by Shapiro-Wilk test (p<0.001).
†Analysis of covariance. The significance level was adjusted for multiple comparisons of treatment group groups using Tukey-Kramer p value adjustments.
‡Begins with the first time point collected after meal and continues until 120 min after meal.
§Daytime (starting from time of waking to time subject went to bed); nocturnal (starting from time subject went to bed to time of waking).5
AUC, area under the curve; Bkfst/AS, breakfast/afternoon snack; Bkfst/PBS, breakfast/prebed snack; DSNS, diabetes-specific nutritional shake; MAGE, mean amplitude of glycemic excursion.