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Original Research

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)

  1. Andrea Laurenzi, MD1,
  2. Andrea M. Bolla, MD1,
  3. Gabriella Panigoni, RD2,
  4. Valentina Doria, MD2,
  5. AnnaChiara Uccellatore, MD2,
  6. Elena Peretti, MD2,
  7. Alessandro Saibene, MD2,
  8. Gabriella Galimberti, MD2,
  9. Emanuele Bosi, MD1⇓ and
  10. Marina Scavini, MD, PHD2
  1. 1San Raffaele Vita-Salute University, Milan, Italy
  2. 2Diabetes and Endocrinology Unit, Department of Internal Medicine, San Raffaele Scientific Institute, Milan, Italy
  1. ↵Corresponding author: Emanuele Bosi, bosi.emanuele{at}hsr.it.
  1. A.L. and A.M.B. contributed equally to this work.

Diabetes Care 2011 Apr; 34(4): 823-827. https://doi.org/10.2337/dc10-1490
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Figures

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    Figure 1

    Flow diagram for the GIOCAR trial.

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    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

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  • 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 participants13 (46.4%)19 (67.9%)0.105
    Age (years)*41.2 ± 10.039.8 ± 9.80.601
    Years of school completed†14 (10–18)13 (13–15.5)0.840
    Duration of diabetes (years)*21.9 ± 11.019.8 ± 11.70.490
    Duration of pump therapy (years)†2 (1–3)2 (0–3.5)0.796
    Type of insulin
     Glulisine14 (50.0%)17 (60.7%)0.340
     Lispro12 (42.9%)7 (25.0%)
     Aspart2 (7.1%)4 (14.3%)
    Insulin requirement (IU/day)†
     Total36 (24.5–49)33 (28.5–39.5)0.282
     Basal22.5 (15–26)18.5 (14–22)0.268
     Boluses15 (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 ± 0.98.1 ± 1.50.526
    • 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 relations2 (−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 complaints2 (0–4.5)2 (−0.5 to 5)0.483
     Worries about future1 (−1 to 4)0 (−1.5 to 3)0.466
     Diet restrictions5.5 (0.5–8.5)0 (−2 to 3.5)0.008
     Daily hassles1.5 (−2.5 to 6)2 (−1.5 to 3.5)0.488
     Fears about hypoglycemia0.5 (−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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Diabetes Care: 34 (4)

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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
Andrea Laurenzi, Andrea M. Bolla, Gabriella Panigoni, Valentina Doria, AnnaChiara Uccellatore, Elena Peretti, Alessandro Saibene, Gabriella Galimberti, Emanuele Bosi, Marina Scavini
Diabetes Care Apr 2011, 34 (4) 823-827; DOI: 10.2337/dc10-1490

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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
Andrea Laurenzi, Andrea M. Bolla, Gabriella Panigoni, Valentina Doria, AnnaChiara Uccellatore, Elena Peretti, Alessandro Saibene, Gabriella Galimberti, Emanuele Bosi, Marina Scavini
Diabetes Care Apr 2011, 34 (4) 823-827; DOI: 10.2337/dc10-1490
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