Effects of Carbohydrate Counting on Glucose Control and Quality of Life Over 24 Weeks in Adult Patients With Type 1 Diabetes on Continuous Subcutaneous Insulin Infusion
A randomized, prospective clinical trial (GIOCAR)
Article Figures & Tables
Figures
- Figure 1
Flow diagram for the GIOCAR trial.
- Figure 2
PP analysis: HbA1c levels (mean and 95% CI) in the two study groups during the GIOCAR trial. The carbohydrate counting group (♦) had significantly lower HbA1c levels than the control group (◇) (P = 0.050).
Tables
- Table 1
Baseline characteristics of study participants by the allocated treatment group (ITT analysis)
Carbohydrate counting (n = 28) Control subjects (n = 28) P value Female participants 13 (46.4%) 19 (67.9%) 0.105 Age (years)* 41.2 ± 10.0 39.8 ± 9.8 0.601 Years of school completed† 14 (10–18) 13 (13–15.5) 0.840 Duration of diabetes (years)* 21.9 ± 11.0 19.8 ± 11.7 0.490 Duration of pump therapy (years)† 2 (1–3) 2 (0–3.5) 0.796 Type of insulin Glulisine 14 (50.0%) 17 (60.7%) 0.340 Lispro 12 (42.9%) 7 (25.0%) Aspart 2 (7.1%) 4 (14.3%) Insulin requirement (IU/day)† Total 36 (24.5–49) 33 (28.5–39.5) 0.282 Basal 22.5 (15–26) 18.5 (14–22) 0.268 Boluses 15 (10.5–21.5) 12.5 (10–20.5) 0.522 BMI (kg/m2)† 23.7 (21–25.2) 23.8 (20.8–26.8) 0.670 Waist circumference (cm)† 83 (78.5–91) 78 (74–85.5) 0.194 Glycated hemoglobin (%)*^ 7.9 ± 0.9 8.1 ± 1.5 0.526 Categorical variables are presented as frequency with percent in parentheses.
↵*Continuous variables with a normal distribution are presented as mean with SD in parentheses.
↵†Continuous variables that do not have a normal distribution are presented as median with the interquartile range in parentheses.
↵^Normal range 3.5–6.0%.
- Table 2
Changes from baseline at week 24 in DSQOLS scores, BMI, and waist circumference by the allocated treatment group (ITT analysis)
Carbohydrate counting (n = 28) Control subjects (n = 28) P value DSQOLS scores Social relations 2 (−2.5 to 3.5) 0 (−1.5 to 5) 0.993 Leisure-time flexibility −0.5 (−2 to 1) 0 (−2 to 3) 0.413 Physical complaints 2 (0–4.5) 2 (−0.5 to 5) 0.483 Worries about future 1 (−1 to 4) 0 (−1.5 to 3) 0.466 Diet restrictions 5.5 (0.5–8.5) 0 (−2 to 3.5) 0.008 Daily hassles 1.5 (−2.5 to 6) 2 (−1.5 to 3.5) 0.488 Fears about hypoglycemia 0.5 (−2 to 7.5) 1 (−5.5 to 5.5) 0.643 BMI (kg/m2) −0.32 (−0.65 to 0) 0.15 (0–0.40) 0.003 Waist circumference (cm) −1 (−2 to 0) 0 (0–2) 0.002 Data are presented as median with the interquartile range in parentheses.
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