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

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

Status
Withdrawn
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05163002
Enrollment
0
Registered
2021-12-20
Start date
2021-05-10
Completion date
2023-04-30
Last updated
2026-02-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Type 1 Diabetes

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.

Interventions

BEHAVIORALNutritional education & carbohydrate counting

Nutrition Education with a multidisciplinary team

Sponsors

Universidade Nova de Lisboa
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Differences between baseline A1c (%) and 90 days after the last educational session.90 daysThe outcome will be assessed through blood exams

Secondary

MeasureTime frameDescription
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 daysThe 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
Difference in time in range (%) between baseline and 90 days following the last educational session90 daysThe outcome will be assessed through data from participants' continuous glucose monitoring system
Difference in the glucose coefficient of variation (%) between baseline and 90 days following the last educational session90 daysThe outcome will be assessed through data from participants' continuous glucose monitoring system
Difference in mean glycaemia (mg /dL) between baseline and 90 days following the last educational session90 daysThe outcome will be assessed through data from participants' continuous glucose monitoring system

Countries

Portugal

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 13, 2026