Diabetes Mellitus, Type 1, Insulin Pump, Programmable
Conditions
Keywords
carbohydrate counting, continuous subcutaneous insulin infusion, type 1 diabetes mellitus
Brief summary
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.
Detailed description
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.
Interventions
BEHAVIORALCarbohydrate counting training
Carbohydrate counting was taught during 4-5 individual sessions with a dietician and a diabetologist.
Sponsors
IRCCS San Raffaele
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* type 1 diabetes mellitus * age 18-65 * continuous subcutaneous insulin infusion for at least 3 months
Exclusion criteria
* patients who have already been trained in carbohydrate counting * known hypothyroidism not on replacement therapy * renal disease (serum creatinine \>1.4 mg/dl in females and \>1.7 mg/dl in males) * patients with celiac disease * pregnancy * serious diseases or disabilities which may interfere with study assessments
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Glycated haemoglobin (HbA1c) | 6 months |
Secondary
| Measure | Time frame |
|---|---|
| Quality of life by Diabetes Specific Quality of Life Scale (DSQOLS) questionnaire | 6 months |
| Fasting glucose | 6 months |
| Glycemic variability (mean, sd, min, max, variability range, BG in target range, LBGI, HBGI) based on capillary glucose data | 6 months |
| Hypoglycemia (capillary glucose<50 mg/dl) | 6 months |
| Body Mass Index (BMI) | 6 months |
| Waist circumference | 6 months |
| Daily insulin requirement (basal daily requirement, bolus daily requirement, total daily requirement) | 6 months |
Countries
Italy
Outcome results
None listed