Type 1 Diabetes Mellitus
Conditions
Keywords
carbohydrate counting, insulin therapy
Brief summary
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
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.
Interventions
BEHAVIORALcarbohydrate counting
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
BEHAVIORALinsulin therapy according to standard care
patients will not manage their insulin therapy depending on the amount of carbohydrates contained in foods, but will follow a fix basal bolus scheme
Sponsors
Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
Study design
Allocation
NON_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 * insulin therapy * HbA1c from 5.5 to 10%
Exclusion criteria
* pregnancy * celiac disease * hepatic impairment * chronic renal failure
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| glycemic control | 2 years | HbA1c |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| anthropometric parameters: WAIST AND HIP CIRCUMFERENCE | 2 years | variations in waist and hip circumference (units: cm) |
| anthropometric parameters: BIOIMPEDENTIOMETRIC PARAMETERS | 2 years | fat mass and free fat mass (units: % of total mass) |
| anthropometric parameters: BMI | 2 years | variations in body mass index (BMI: units kg/m2), weight and height will be combined to report BMI in kg/m\^2 |
| glucose variability: mean and standard deviation of self monitoring blood glucose (SMBG) | 2 YEARS | mean and standard deviation of self monitoring blood glucose (SMBG), data collected from glucometers, units: mg/dl |
| glucose variability: incidence of hypoglycaemia | 2 YEARS | incidence of hypoglycaemia (SMBG \< 70 mg/dl), units: n° episodes/week |
| dietary lifestyle | 2 years | 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. |
Countries
Italy
Contacts
Primary ContactEmanuela Orsi, MD
Backup Contactvaleria grancini, MD
Outcome results
None listed