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).

OBJECTIVE: Few studies have assessed the efficacy of carbohydrate counting in type 1 diabetes, and none have validated its efficacy in patients who are treated with continuous subcutaneous insulin infusion (CSII). The aim of our study was to test the effect of carbohydrate counting on glycemic control and quality of life in adult patients with type 1 diabetes who are receiving CSII. RESEARCH DESIGN AND METHODS: Sixty-one adult patients with type 1 diabetes treated with CSII were randomly assigned to either learning carbohydrate counting (intervention) or estimating pre-meal insulin dose in the usual empirical way (control). At baseline and 12 and 24 weeks, we measured HbA(1c), fasting plasma glucose, BMI, waist circumference, recorded daily insulin dose, and capillary glucose data, and administered the Diabetes-Specific Quality-of-Life Scale (DSQOLS) questionnaire. RESULTS: Intention-to-treat analysis showed improvement of the DSQOLS score related to diet restrictions (week 24 - baseline difference, P = 0.008) and reduction of BMI (P = 0.003) and waist circumference (P = 0.002) in the intervention group compared with control subjects. No changes in HbA(1c), fasting plasma glucose, daily insulin dose, and hypoglycemic episodes (<2.8 mmol/L) were observed. Per-protocol analysis, including only patients who continuously used carbohydrate counting and CSII during the study, confirmed improvement of the DSQOLS score and reduction of BMI and waist circumference, and showed a significant reduction of HbA(1c) (-0.35% vs. control subjects, P = 0.05). CONCLUSIONS: Among adult patients with type 1 diabetes treated with CSII, carbohydrate counting is safe and improves quality of life, reduces BMI and waist circumference, and, in per-protocol analysis, reduces HbA(1c).