DM1, Effects of Carbo-Counting on Glycemic Control

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Effectiveness of Carbohydrate Counting on Glycaemic Control in T1DM Patients

Conditions
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Type 1 Diabetes Mellitus

Intervention / Treatment
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* Behavioral: carbohydrate counting
* Behavioral: insulin therapy according to standard care


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: type 1 diabetes mellitus insulin therapy HbA1c from 5.5 to 10% Exclusion Criteria: pregnancy celiac disease hepatic impairment chronic renal failure

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: carbo-counters<br>carbohydrate counting: patients attending a structured carbohydrate-counting training and practicing this tecnique to manage insulin therapy | Behavioral: carbohydrate counting<br>* 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<br>|
| Active Comparator: control group<br>insulin therapy according to standard care. patients who don't practice carbohydrate-counting to manage insulin therapy | Behavioral: insulin therapy according to standard care<br>* patients will not manage their insulin therapy depending on the amount of carbohydrates contained in foods, but will follow a fix basal bolus scheme<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| glycemic control | HbA1c | 2 years | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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carbohydrate counting, insulin therapy