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)
- Andrea Laurenzi, MD1,
- Andrea M. Bolla, MD1,
- Gabriella Panigoni, RD2,
- Valentina Doria, MD2,
- AnnaChiara Uccellatore, MD2,
- Elena Peretti, MD2,
- Alessandro Saibene, MD2,
- Gabriella Galimberti, MD2,
- Emanuele Bosi, MD1⇓ and
- Marina Scavini, MD, PHD2
- 1San Raffaele Vita-Salute University, Milan, Italy
- 2Diabetes and Endocrinology Unit, Department of Internal Medicine, San Raffaele Scientific Institute, Milan, Italy
- ↵Corresponding author: Emanuele Bosi, .
A.L. and A.M.B. contributed equally to this work.
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 HbA1c, 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 HbA1c, 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 HbA1c (−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 HbA1c.
Clinical trial reg. no. NCT01173991, clinicaltrials.gov.
- Received August 2, 2010.
- Accepted January 25, 2011.
- © 2011 by the American Diabetes Association.
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