Effectiveness of Nutrition Education in Carbohydrate Counting in People With Type 1 Diabetic
Primary Purpose
Type 1 Diabetes
Status
Recruiting
Phase
Not Applicable
Locations
Portugal
Study Type
Interventional
Intervention
Nutritional education & carbohydrate counting
Sponsored by
About this trial
This is an interventional treatment trial for Type 1 Diabetes
Eligibility Criteria
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
Sites / Locations
- Nova Medical SchoolRecruiting
Outcomes
Primary Outcome Measures
Differences between baseline A1c (%) and 90 days after the last educational session.
Secondary Outcome Measures
Difference in the level of knowledge on nutrition and carbohydrate counting, assessed through a questionnaire collected at baseline and in the last educational session
Difference in time in range (%) between baseline and 90 days following the last educational session
Difference in the glucose coefficient of variation (%) between baseline and 90 days following the last educational session
Difference in mean glycaemia (mg /dL) between baseline and 90 days following the last educational session
Full Information
NCT ID
NCT05163002
First Posted
December 6, 2021
Last Updated
December 6, 2021
Sponsor
Universidade Nova de Lisboa
1. Study Identification
Unique Protocol Identification Number
NCT05163002
Brief Title
Effectiveness of Nutrition Education in Carbohydrate Counting in People With Type 1 Diabetic
Official Title
Effectiveness of Nutrition Education in Carbohydrate Counting, in a Group Context, on Glycemic Control in People With Type 1 Diabetic
Study Type
Interventional
2. Study Status
Record Verification Date
December 2021
Overall Recruitment Status
Recruiting
Study Start Date
May 10, 2021 (Actual)
Primary Completion Date
July 29, 2022 (Anticipated)
Study Completion Date
July 29, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Universidade Nova de Lisboa
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 1 Diabetes
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
106 (Anticipated)
8. Arms, Groups, and Interventions
Intervention Type
Behavioral
Intervention Name(s)
Nutritional education & carbohydrate counting
Intervention Description
Nutrition Education with a multidisciplinary team
Primary Outcome Measure Information:
Title
Differences between baseline A1c (%) and 90 days after the last educational session.
Time Frame
90 days
Secondary Outcome Measure Information:
Title
Difference in the level of knowledge on nutrition and carbohydrate counting, assessed through a questionnaire collected at baseline and in the last educational session
Time Frame
90 days
Title
Difference in time in range (%) between baseline and 90 days following the last educational session
Time Frame
90 days
Title
Difference in the glucose coefficient of variation (%) between baseline and 90 days following the last educational session
Time Frame
90 days
Title
Difference in mean glycaemia (mg /dL) between baseline and 90 days following the last educational session
Time Frame
90 days
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Marta A. Leal, BSc
Phone
+351969415666
Email
martaalbuquerqueleal@gmail.com
Facility Information:
Facility Name
Nova Medical School
City
Lisboa
ZIP/Postal Code
1169-056
Country
Portugal
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Marta A. Leal, BSc
Phone
+351 969415666
Email
martaalbuquerqueleal@gmail.com
12. IPD Sharing Statement
Learn more about this trial
Effectiveness of Nutrition Education in Carbohydrate Counting in People With Type 1 Diabetic
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