MedPath

DM1, Effects of Carbo-Counting on Glycemic Control

Not Applicable
Conditions
Type 1 Diabetes Mellitus
Registration Number
NCT03554590
Lead Sponsor
Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
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
Inclusion Criteria
  • type 1 diabetes mellitus
  • insulin therapy
  • HbA1c from 5.5 to 10%
Exclusion Criteria
  • pregnancy
  • celiac disease
  • hepatic impairment
  • chronic renal failure

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Primary Outcome Measures
NameTimeMethod
glycemic control2 years

HbA1c

Secondary Outcome Measures
NameTimeMethod
dietary lifestyle2 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 hypoglycaemia2 YEARS

incidence of hypoglycaemia (SMBG \< 70 mg/dl), units: n° episodes/week

anthropometric parameters: BMI2 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 CIRCUMFERENCE2 years

variations in waist and hip circumference (units: cm)

anthropometric parameters: BIOIMPEDENTIOMETRIC PARAMETERS2 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, Italy
Valeria Grancini, MD
Contact
00393926233299
valeria_grancini@hotmail.it

MedPath

Empowering clinical research with data-driven insights and AI-powered tools.

© 2025 MedPath, Inc. All rights reserved.