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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Carbohydrate counting | Experimental | This group received carbohydrate counting training |
|
| Controls | No Intervention | This group received standard education |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Carbohydrate counting training | Behavioral | Carbohydrate counting was taught during 4-5 individual sessions with a dietician and a diabetologist. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Glycated haemoglobin (HbA1c) | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Emanuele Bosi, MD | San Raffaele Scientific Institute, Milano Italy | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| San Raffaele Scientific Institute | Milan | 20132 | Italy |
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| ID | Term |
|---|---|
| D003922 | Diabetes Mellitus, Type 1 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| Daily insulin requirement (basal daily requirement, bolus daily requirement, total daily requirement) |
| 6 months |
| Body Mass Index (BMI) | 6 months |
| Waist circumference | 6 months |
| Quality of life by Diabetes Specific Quality of Life Scale (DSQOLS) questionnaire | 6 months |
| Hypoglycemia (capillary glucose<50 mg/dl) | 6 months |
| D004700 | Endocrine System Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |