DM1, Effects of Carbo-Counting on Glycemic Control

Effectiveness of Carbohydrate Counting on Glycaemic Control in T1DM Patients

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.

Study Overview

• Status: Unknown
• Conditions: Type 1 Diabetes Mellitus
• Intervention / Treatment: Behavioral: carbohydrate counting; Behavioral: insulin therapy according to standard care

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 Type: Interventional
• Enrollment (Anticipated): 50
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Emanuela Orsi, MD; Phone Number: 0255034590; Email: emanuela_orsi@yahoo.it
• Study Contact Backup: Name: valeria grancini, MD; Phone Number: 0039 3926233299; Email: valeria_grancini@hotmail.it

Study Locations

• Italy
  • Milan, Italy, 20133
    • Recruiting
    • Fondazione Irccs Ca' Granda Ospedale Maggiore Policlinico
    • Contact: Valeria Grancini, MD; Phone Number: 00393926233299; Email: valeria_grancini@hotmail.it

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: carbo-counters; carbohydrate counting: patients attending a structured carbohydrate-counting training and practicing this tecnique to manage insulin therapy	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
Active Comparator: control group; insulin therapy according to standard care. patients who don't practice carbohydrate-counting to manage insulin therapy	Behavioral: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
glycemic control	HbA1c	2 years

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
• Investigators: Principal Investigator: Emanuela Orsi, FOndazione IRCCS Ca' Granda Opedale Maggiore Policlinico Milano

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2016
• Primary Completion (Anticipated): December 1, 2018
• Study Completion (Anticipated): January 1, 2020

Study Registration Dates

• First Submitted: March 3, 2017
• First Submitted That Met QC Criteria: May 31, 2018
• First Posted (Actual): June 13, 2018

Study Record Updates

• Last Update Posted (Actual): June 13, 2018
• Last Update Submitted That Met QC Criteria: May 31, 2018
• Last Verified: May 1, 2018

More Information

Terms related to this study

• Keywords: insulin therapy; carbohydrate counting
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Immune System Diseases; Autoimmune Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 1; Hypoglycemic Agents; Physiological Effects of Drugs; Insulin
• Other Study ID Numbers: DM1cc

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No