DM1, Effects of Carbo-Counting on Glycemic Control

Not Applicable

• Conditions: Type 1 Diabetes Mellitus
• Interventions: Behavioral: carbohydrate counting; Behavioral: insulin therapy according to standard care

• 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.

Study Timeline

• Study Start: 2016-12
• Study First Submitted: 2017-03-03
• Status Verified: 2018-05
• Study First Submitted QC: 2018-05-31
• Last Update Submitted: 2018-05-31
• Study First Posted: 2018-06-13
• Last Update Posted: 2018-06-13
• Primary Completion: 2018-12
• Study Completion: 2020-01

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

Arm && Interventions

Group	Intervention	Description
carbo-counters	carbohydrate counting	carbohydrate counting: patients attending a structured carbohydrate-counting training and practicing this tecnique to manage insulin therapy
control group	insulin therapy according to standard care	insulin therapy according to standard care. patients who don't practice carbohydrate-counting to manage insulin therapy

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