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

Type 1 Diabetes Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05163002
• Other study ID #: Universidade Nova de Lisboa
• Status: Recruiting
• Phase: N/A
• Start date: May 10, 2021
• Est. completion date: July 29, 2022

Study information

• Verified date: December 2021
• Source: Universidade Nova de Lisboa
• Contact: Marta A. Leal, BSc
• Phone: +351969415666
• Email: martaalbuquerqueleal[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 106
• Est. completion date: July 29, 2022
• Est. primary completion date: July 29, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 1
• Type 1 Diabetes

Intervention

Behavioral:
• Nutritional education & carbohydrate counting
Nutrition Education with a multidisciplinary team

Locations

Country	Name	City	State
Portugal	Nova Medical School	Lisboa

Sponsors (1)

Lead Sponsor	Collaborator
Universidade Nova de Lisboa

Country where clinical trial is conducted

Portugal, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Differences between baseline A1c (%) and 90 days after the last educational session.		90 days
Secondary	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
Secondary	Difference in time in range (%) between baseline and 90 days following the last educational session		90 days
Secondary	Difference in the glucose coefficient of variation (%) between baseline and 90 days following the last educational session		90 days
Secondary	Difference in mean glycaemia (mg /dL) between baseline and 90 days following the last educational session		90 days