The investigators postulate that carbohydrate (CHO) counting in adult patients with type 1 diabetes mellitus (T1DM) treated with continuous subcutaneous insulin infusion (CSII) may improve glycemic control, glycemic variability and quality of life.
This study was designed as a randomized, controlled (versus standard education), open, one-center trial. Patients in group 1 were taught carbohydrate counting to estimate insulin preprandial bolus, while the patients in group 2 followed standard education. Primary outcome (glycosylated hemoglobin, HbA1c) and secondary outcomes (fasting glucose, glycemic variability, insulin requirement, body mass index (BMI), waist circumference, quality of life) were measured at baseline, 3, and 6 months.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
61
Carbohydrate counting was taught during 4-5 individual sessions with a dietician and a diabetologist.
San Raffaele Scientific Institute
Milan, Italy
Glycated haemoglobin (HbA1c)
Time frame: 6 months
Fasting glucose
Time frame: 6 months
Glycemic variability (mean, sd, min, max, variability range, BG in target range, LBGI, HBGI) based on capillary glucose data
Time frame: 6 months
Daily insulin requirement (basal daily requirement, bolus daily requirement, total daily requirement)
Time frame: 6 months
Body Mass Index (BMI)
Time frame: 6 months
Waist circumference
Time frame: 6 months
Quality of life by Diabetes Specific Quality of Life Scale (DSQOLS) questionnaire
Time frame: 6 months
Hypoglycemia (capillary glucose<50 mg/dl)
Time frame: 6 months
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