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

Not Applicable

• Conditions: Type 1 Diabetes

• Registration Number: NCT05163002
• Lead Sponsor: Universidade Nova de Lisboa

Brief Summary

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

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 Timeline

• Study Start: 2021-05-10
• Status Verified: 2021-12
• Study First Submitted: 2021-12-06
• Study First Submitted QC: 2021-12-06
• Last Update Submitted: 2021-12-06
• Study First Posted: 2021-12-20
• Last Update Posted: 2021-12-20
• Primary Completion: 2022-07-29
• Study Completion: 2022-07-29

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 106

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Differences between baseline A1c (%) and 90 days after the last educational session.	90 days

Secondary Outcome Measures

Name	Time	Method
Difference in the level of knowledge on nutrition and carbohydrate counting, assessed through a questionnaire collected at baseline and in the last educational session	90 days
Difference in time in range (%) between baseline and 90 days following the last educational session	90 days
Difference in the glucose coefficient of variation (%) between baseline and 90 days following the last educational session	90 days
Difference in mean glycaemia (mg /dL) between baseline and 90 days following the last educational session	90 days

Trial Locations

Locations (1)

Nova Medical School; 🇵🇹 Lisboa, Portugal