DM1, Effects of Carbo-Counting on Glycemic Control

Type 1 Diabetes Mellitus Clinical Trial

Official title:

Effectiveness of Carbohydrate Counting on Glycaemic Control in T1DM Patients

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03554590
• Other study ID #: DM1cc
• Status: Recruiting
• Phase: N/A
• Start date: December 2016
• Est. completion date: January 2020

Study information

• Verified date: May 2018
• Source: Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
• Contact: Emanuela Orsi, MD
• Phone: 0255034590
• Email: emanuela_orsi[@]yahoo.it
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: January 2020
• Est. primary completion date: December 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• type 1 diabetes mellitus

• insulin therapy

• HbA1c from 5.5 to 10%

Exclusion Criteria:

• pregnancy

• celiac disease

• hepatic impairment

• chronic renal failure

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 1
• Type 1 Diabetes Mellitus

Intervention

Behavioral:
• carbohydrate 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
• insulin 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

Locations

Country	Name	City	State
Italy	Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico	Milan

Sponsors (1)

Lead Sponsor	Collaborator
Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	glycemic control	HbA1c	2 years
Secondary	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
Secondary	anthropometric parameters: WAIST AND HIP CIRCUMFERENCE	variations in waist and hip circumference (units: cm)	2 years
Secondary	anthropometric parameters: BIOIMPEDENTIOMETRIC PARAMETERS	fat mass and free fat mass (units: % of total mass)	2 years
Secondary	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
Secondary	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
Secondary	glucose variability: incidence of hypoglycaemia	incidence of hypoglycaemia (SMBG < 70 mg/dl), units: n° episodes/week	2 YEARS