DM1, Effects of Carbo-Counting on Glycemic Control

NCT03554590 | Unknown

• 1 other identifier: DM1cc
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Type 1 Diabetes Mellitus

Keywords

carbohydrate counting; insulin therapy

Outcome Measures

Primary Outcomes (1)

• glycemic control

  HbA1c

  2 years

Secondary Outcomes (6)

• anthropometric parameters: BMI

  2 years

• anthropometric parameters: WAIST AND HIP CIRCUMFERENCE

  2 years

• anthropometric parameters: BIOIMPEDENTIOMETRIC PARAMETERS

  2 years

• dietary lifestyle

  2 years

• glucose variability: mean and standard deviation of self monitoring blood glucose (SMBG)

  2 YEARS

Study Arms (2)

carbo-counters

EXPERIMENTAL

carbohydrate counting: patients attending a structured carbohydrate-counting training and practicing this tecnique to manage insulin therapy

Behavioral: carbohydrate counting

control group

ACTIVE COMPARATOR

insulin therapy according to standard care. patients who don't practice carbohydrate-counting to manage insulin therapy

Behavioral: insulin therapy according to standard care

Interventions

carbohydrate counting BEHAVIORAL

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

carbo-counters

insulin therapy according to standard care BEHAVIORAL

patients will not manage their insulin therapy depending on the amount of carbohydrates contained in foods, but will follow a fix basal bolus scheme

control group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• type 1 diabetes mellitus
• insulin therapy
• HbA1c from 5.5 to 10%

You may not qualify if:

• pregnancy
• celiac disease
• hepatic impairment
• chronic renal failure

Sponsors & Collaborators

• Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico: lead

Study Sites (1)

Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico

Milan, 20133, Italy

RECRUITING

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Emanuela Orsi

  FOndazione IRCCS Ca' Granda Opedale Maggiore Policlinico Milano

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Emanuela Orsi, MD

CONTACT

0255034590; emanuela_orsi@yahoo.it

valeria grancini, MD

CONTACT

0039 3926233299; valeria_grancini@hotmail.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of DIabetology

Study Record Dates

• First Submitted: March 3, 2017
• First Posted: June 13, 2018
• Study Start: December 1, 2016
• Primary Completion: December 1, 2018
• Study Completion: January 1, 2020
• Last Updated: June 13, 2018

Record last verified: 2018-05

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)