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Effectiveness of Nutrition Education in Carbohydrate Counting in People With Type 1 Diabetic

NCT ID: NCT05163002

Last Updated: 2021-12-20

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

106 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-05-10

Study Completion Date

2022-07-29

Brief Summary

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Carbohydrates are the nutrient in the diet with the greatest impact on blood glucose. Inadequate carbohydrate counts are associated with higher A1c and greater variations in postprandial blood glucose. Clinical guidelines for the nutritional treatment of diabetes recommend that patients with DM1 learn carbohydrate counting or some similar systematic strategy that allows for better metabolic control. However, despite the recommendations, this is still not a reality for most healthcare services treating individuals diagnosed with DM1.

Detailed Description

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The study aims to assess the impact of a structured nutrition education programme for nutritional education and carbohydrate counting, in group sessions, on glycemic control and nutritional literacy in people with DM1. This will be achieved by evaluating the glycaemic control through A1c and daily glycaemic variability (time on target, mean glycaemia), as well as the level of knowledge before and after the intervention.

Conditions

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Type 1 Diabetes

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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Nutritional education & carbohydrate counting

Nutrition Education with a multidisciplinary team

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* Adults aged ≥18 years old who have been diagnosed with type 1 diabetes or parents of children and adolescents (\< 18 years old) who have been diagnosed with type 1 diabetes;
* To be under intensive insulin therapy (basal/bolus system);
* To regularly use a continuous glucose monitoring system as primary method for glycaemic control;
* To be able to read and write.

Exclusion Criteria

* None
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Universidade Nova de Lisboa

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Nova Medical School

Lisbon, , Portugal

Site Status RECRUITING

Countries

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Portugal

Central Contacts

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Marta A. Leal, BSc

Role: CONTACT

Phone: +351969415666

Email: [email protected]

Facility Contacts

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Marta A. Leal, BSc

Role: primary

Other Identifiers

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Universidade Nova de Lisboa

Identifier Type: -

Identifier Source: org_study_id