DM1, Effects of Carbo-Counting on Glycemic Control
- Conditions
- Type 1 Diabetes Mellitus
- Registration Number
- NCT03554590
- 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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 50
- type 1 diabetes mellitus
- insulin therapy
- HbA1c from 5.5 to 10%
- pregnancy
- celiac disease
- hepatic impairment
- chronic renal failure
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method glycemic control 2 years HbA1c
- Secondary Outcome Measures
Name Time Method 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.
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
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
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)
Trial Locations
- Locations (1)
Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico
🇮🇹Milan, Italy
Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico🇮🇹Milan, ItalyValeria Grancini, MDContact00393926233299valeria_grancini@hotmail.it