Effectiveness of Carbohydrate Counting on Glycaemic Control in T1DM Patients
Trial Snapshot
- Phase
- Not Applicable
- Enrollment
- 50
- Locations
- 1
- Primary Endpoint
- glycemic control
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts 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
Arms & Interventions
carbo-counters
carbohydrate counting: patients attending a structured carbohydrate-counting training and practicing this tecnique to manage insulin therapy
Intervention: carbohydrate counting (Behavioral)
control group
insulin therapy according to standard care. patients who don't practice carbohydrate-counting to manage insulin therapy
Intervention: insulin therapy according to standard care (Behavioral)
Outcomes
Primary Outcomes
glycemic control
Time Frame: 2 years
HbA1c
Secondary Outcomes
- dietary lifestyle(2 years)
- glucose variability: mean and standard deviation of self monitoring blood glucose (SMBG)(2 YEARS)
- glucose variability: incidence of hypoglycaemia(2 YEARS)
- anthropometric parameters: BMI(2 years)
- anthropometric parameters: WAIST AND HIP CIRCUMFERENCE(2 years)
- anthropometric parameters: BIOIMPEDENTIOMETRIC PARAMETERS(2 years)
Investigators
Emanuela Orsi
Head of DIabetology
Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico