DM1, Effects of Carbo-Counting on Glycemic Control

NCT ID: NCT03554590

Last Updated: 2018-06-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-12-31

Study Completion Date

2020-01-31

Brief Summary

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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

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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.

Conditions

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Type 1 Diabetes Mellitus

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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carbo-counters

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

Group Type EXPERIMENTAL

carbohydrate counting

Intervention Type 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

control group

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

Group Type ACTIVE_COMPARATOR

insulin therapy according to standard care

Intervention Type 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

Interventions

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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

Intervention Type 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

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* pregnancy
* celiac disease
* hepatic impairment
* chronic renal failure
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico

OTHER

Sponsor Role lead

Responsible Party

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Emanuela Orsi

Head of DIabetology

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Emanuela Orsi

Role: PRINCIPAL_INVESTIGATOR

FOndazione IRCCS Ca' Granda Opedale Maggiore Policlinico Milano

Locations

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Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico

Milan, , Italy

Site Status RECRUITING

Countries

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Italy

Central Contacts

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Emanuela Orsi, MD

Role: CONTACT

0255034590

valeria grancini, MD

Role: CONTACT

0039 3926233299

Facility Contacts

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Valeria Grancini, MD

Role: primary

00393926233299

Other Identifiers

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DM1cc

Identifier Type: -

Identifier Source: org_study_id

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