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Carbohydrate counting is the most effective meal-planning strategy in type 1 diabetes (T1DM) to optimize insulin therapy. However, it may lead to weight gain and unhealthy eating habits. This study aims to compare glycemic control parameters, anthropometric measurements and dietary lifestyle in T1DM patients who practice CHO-counting, after attending a structured course to learn how to manage this tecnique, vs a control Group, in a follow up period of 2 years.
patients with type 1 DM will be enrolled in the study. patients in the intervention group will attend a 5-lessons training to learn how to manage insulin therapy depending on the amount of carbohydrates in their meals, patients in the control group will be follow according to the the standard care. after the follow up period glycometabolic, anthropometric parameters and dietary lifestyle changes will be compared between the two groups.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| carbo-counters | Experimental | carbohydrate counting: patients attending a structured carbohydrate-counting training and practicing this tecnique to manage insulin therapy |
|
| control group | Active Comparator | insulin therapy according to standard care. patients who don't practice carbohydrate-counting to manage insulin therapy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| carbohydrate counting | Behavioral | patients will attend a 5 meetings-structured training to learn how to manage their insulin therapy depending on the amount of carbohydrates contained in foods |
| Measure | Description | Time Frame |
|---|---|---|
| glycemic control | HbA1c | 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| anthropometric parameters: BMI | variations in body mass index (BMI: units kg/m2), weight and height will be combined to report BMI in kg/m^2 | 2 years |
| anthropometric parameters: WAIST AND HIP CIRCUMFERENCE |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Emanuela Orsi, MD | Contact | 0255034590 | emanuela_orsi@yahoo.it | |
| valeria grancini, MD | Contact | 0039 3926233299 | valeria_grancini@hotmail.it |
| Name | Affiliation | Role |
|---|---|---|
| Emanuela Orsi | FOndazione IRCCS Ca' Granda Opedale Maggiore Policlinico Milano | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico | Recruiting | Milan | 20133 | 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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| insulin therapy according to standard care | Behavioral | patients will not manage their insulin therapy depending on the amount of carbohydrates contained in foods, but will follow a fix basal bolus scheme |
|
variations in waist and hip circumference (units: cm)
| 2 years |
| anthropometric parameters: BIOIMPEDENTIOMETRIC PARAMETERS | fat mass and free fat mass (units: % of total mass) | 2 years |
| dietary lifestyle | variations in intake of simple sugars, animal protein rich foods, saturated fats and cholesterol, UDM: grams/die. All the informations will be collected using 5days food diaries, completed by the patients. | 2 years |
| glucose variability: mean and standard deviation of self monitoring blood glucose (SMBG) | mean and standard deviation of self monitoring blood glucose (SMBG), data collected from glucometers, units: mg/dl | 2 YEARS |
| glucose variability: incidence of hypoglycaemia | incidence of hypoglycaemia (SMBG < 70 mg/dl), units: n° episodes/week | 2 YEARS |
| D004700 | Endocrine System Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |