Study Stopped
Recruitment difficulties
Effectiveness of Nutrition Education in Carbohydrate Counting in People With Type 1 Diabetic
1 other identifier
interventional
N/A
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
Started May 2021
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 10, 2021
CompletedFirst Submitted
Initial submission to the registry
December 6, 2021
CompletedFirst Posted
Study publicly available on registry
December 20, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 31, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
April 30, 2023
CompletedFebruary 12, 2026
February 1, 2026
1.7 years
December 6, 2021
February 9, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
Differences between baseline A1c (%) and 90 days after the last educational session.
The outcome will be assessed through blood exams
90 days
Secondary Outcomes (4)
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).
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
Study Arms (1)
Intervention
EXPERIMENTALIntervention arm, uncontrolled
Interventions
Nutrition Education with a multidisciplinary team
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- None
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Nova Medical School
Lisbon, 1169-056, Portugal
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 6, 2021
First Posted
December 20, 2021
Study Start
May 10, 2021
Primary Completion
January 31, 2023
Study Completion
April 30, 2023
Last Updated
February 12, 2026
Record last verified: 2026-02