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

February 9, 2026 updated by: Universidade Nova de Lisboa

Effectiveness of Nutrition Education in Carbohydrate Counting, in a Group Context, on Glycemic Control in People With Type 1 Diabetic

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.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Portugal
      • Lisbon, Portugal, 1169-056
        • NOVA Medical School

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intervention
Intervention arm, uncontrolled
Behavioral: Nutritional education & carbohydrate counting
Nutrition Education with a multidisciplinary team

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Differences between baseline A1c (%) and 90 days after the last educational session.
Time Frame: 90 days
The outcome will be assessed through blood exams
90 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Difference in the level of nutritional knowledge assessed through a questionnaire "Nutrition knowledge" collected at baseline and in the last educational session (scale 0 to 23, where 23 is the highest).
Time Frame: 90 days
The level of knowledge will be measure in a likert scale from 0 (minimum) to 23 (maximum), where a higher score is better than a lower one
90 days
Difference in time in range (%) between baseline and 90 days following the last educational session
Time Frame: 90 days
The outcome will be assessed through data from participants' continuous glucose monitoring system
90 days
Difference in the glucose coefficient of variation (%) between baseline and 90 days following the last educational session
Time Frame: 90 days
The outcome will be assessed through data from participants' continuous glucose monitoring system
90 days
Difference in mean glycaemia (mg /dL) between baseline and 90 days following the last educational session
Time Frame: 90 days
The outcome will be assessed through data from participants' continuous glucose monitoring system
90 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Universidade Nova de Lisboa

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 10, 2021

Primary Completion (Estimated)

January 31, 2023

Study Completion (Estimated)

April 30, 2023

Study Registration Dates

First Submitted

December 6, 2021

First Submitted That Met QC Criteria

December 6, 2021

First Posted (Actual)

December 20, 2021

Study Record Updates

Last Update Posted (Actual)

February 12, 2026

Last Update Submitted That Met QC Criteria

February 9, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Universidade Nova de Lisboa

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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