Table 2.
Evaluation of moderate carbohydrate diet vs traditional diet on primary and secondary endpoints in the FAS population.
| Variable | Moderate carbohydrate diet | Traditional diet | Mean difference/Fold change (95% CI) |
|---|---|---|---|
| CGM mean (mmol/L) | 8.6 (1.7) | 9.2 (1.9) | −0.6 (−0.9 to −0.3) p <.001a |
| CGM SD (mmol/L) | 3.6 (1.0) | 3.7 (0.9) | −0.1 (−0.3 to 0.0) p = 0.15 |
| Percent time in range 3.9–10 mmol/L | 57.9 (13.4) | 53.5 (16.9) | 4.7 (1.3 to 8.0) p = 0.008 |
| Percent time above range >10 mmol/L | 32.8 (16.5) | 38.4 (19.6) | −5.9 (−9.6 to −2.2) p = 0.003 |
| Percent time in hyperglycaemia >13.9 mmol/L | 10.4 (10.0) | 13.7 (13.1) | −3.6 (−6.1 to −1.1) p = 0.006 |
| Percent time in hypoglycaemia <3.0 mmol/L | 3.8 (4.1) | 3.2 (3.3) | 0.6 (−0.4 to 1.6) p = 0.26 |
| Percent time below range <3.9 mmol/L | 9.4 (7.3) | 8.1 (6.1) | 1.2 (−0.4 to 2.9) p = 0.13 |
| Weight (kg) | 86.7 (17.4) | 86.3 (17.7) | 0.0 (−0.4 to 0.4) p = 0.98 |
| Total cholesterol (mmol/L) | 4.1 (3.6–4.5) | 4.2 (3.6–4.8) | 0.98 (0.95 to 1.01)b p = 0.28 |
| Low-density lipoprotein (mmol/L) | 2.2 (1.7–2.7) | 2.2 (1.7–2.6) | 0.98 (0.93 to 1.03)b p = 0.44 |
| High-density lipoprotein (mmol/L) | 1.4 (1.1–1.8) | 1.5 (1.2–1.7) | 0.99 (0.95 to 1.04)b p = 0.68 |
| Triglycerides (mmol/L) | 0.9 (0.6–1.3) | 1.0 (0.7–1.3) | 0.99 (0.88 to 1.10)b p = 0.79 |
| Total daily insulin dose (IU) | 56.2 (39.6) | 59.7 (39.1) | −3.3 (−7.5 to 0.9) p = 0.12 |
| DTSQs total score | 28.7 (5.4) | 27.4 (6.1) | 1.4 (0.2 to 2.5) p = 0.026 |
| Hypoglycaemia confidence scale mean score | 3.5 (0.5) | 3.5 (0.4) | 0.0 (−0.1 to 0.1) p = 0.55 |
Data are presented as mean (SD) and mean difference (95% CI) or median (IQR) and fold-change (95% CI).
Statistical analyses were performed using linear mixed effects models with treatment (diet) and period as fixed effects and subject as random effect.
Abbreviations: CI, confidence interval; IQR, interquartile range; SD, standard deviation.
a
This is a confirmatory finding according to the pre-defined testing procedure (see Statistical Analysis Plan, eMethods3, for details).
b
Fold change between groups is presented.