Carbohydrate Counting in Children and Adolescents With Type 1 Diabetes

The total amount of carbohydrates (CHO) at meal consumed strongly predicts the glycemic response in children and adolescents with type 1 diabetes. Carbohydrate counting is a technique to adapt a dose of rapid acting insulin to the carbohydrate content of a meal. Thanks to this flexible insuline therapy, the glycemic control and the quality of life tend to improve. Carbohydrate counting is a recommended technique in the adult diabetic population. There is little data on the use of this methode in youth with diabetes. There are no studies on the change of carbohydrates content at meals in children and adolescents with diabetes practicing counting carbs, while it is the main interest of this technique. The aim of this study is to assess how children and adolescents with type 1 diabetes use the possibility to change their carbohydrate amount at each main meal when they use the counting carb method. The investigators hypothesize that children vary their amount of CHO greatly. This is an argument for using this technique in pediatrics

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Key information

Conditions

Type 1 Diabetes Autoimmune Diseases Diabetes Mellitus Diabetes Mellitus, Type 1 Endocrine System Diseases Glucose Metabolism Disorders Immune System Diseases Metabolic Diseases Nutritional and Metabolic Diseases

Age range

1 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Fondation Lenval

Nice, 06200, France

About this study

The chalenge of the treatment of children and adolescents with type 1 diabetes is to maintain a normoglycemia to prevent the complications of diabetes. The post prandial glycemic control is directly inflenced by the CHO content of the meal and the carbohydrates must represent about 55% of the daily needs. There is a linear relation between carbohydrate intake and insuline need. CHO counting is a technique to match a bolus insuline dose to the total carbohydrate content of the meal. An insulin to carbohydrate ratio is used. The method contrasts with fixed insulin regimen. There is a lack of studies on CHO counting particulary in pediatric population. However, there are currently international recommendations supporting the use of CHO counting in the management of type 1 diabetes because it improves the quality of life, tends to improve the HbA1c and limits hypoglycemia without increasing the BMI. There is no pediatric study on the variation of the amount of CHO at each of the main 4 daily meals.

Aims The investigators hypothesize that children vary greatly their total meal CHO .This is an argument for this technique.

Primary aim :

To assess how children and adolescents (aged 1 to 18) use this possibility to change the amount of CHO at breakfast, at lunch, at snack, at dinner and from day to day.

Secondary aims :

To identify a correlation between the variation of CHO and environnemental factors such as school or disease and medical factors such as glycemic control and BMI.
To compare the total CHO intake of our pediatric population with international recommendations Methods A logbook is given to the patient to detail the amount of carbohydrates in the meal and place and event during these meal.

This self monitoring logbook must be completed over 28 days between two consultations.

The investigators will include 80 patients during 18 months

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Treated for type 1 diabetes with a basal bolus regimen and practicing counting carbohydrates for nine months or more
With autoantibodies positive (anti-gad, anti-ia2, anti-islets ) or HLA typing predisposing to type 1 diabetes
Aged 1 to 18 years
affiliation to a social security scheme
Less than three oversights of bolus insulin in the week prior to inclusion

Exclusion criteria

Aged less than 1 or more than 18 years
Autoantibody negative and HLA does not predispose to type 1 diabetes
No affiliation to a social security scheme
More than two omissions of bolus insulin in the week before the inclusion

Treatment and study plan

carbohydrate counting

Other

patients must fill their logbook with the following data:

cho amount at breakfast, lunch, snack and dinner
insulin amount at breakfast, lunch, snack and dinner

Primary outcomes

The individual variation of CHO amount at each main meal : Breakfast, Lunch, Snacks, Dinner

Time frame: each day during 28 days

the patients must fill their logbook during 28 days

Sponsors and collaborators

Lead sponsor

Fondation Lenval

Other

Registry information

Official study title

Analysis of the Individual Variation of the Carbohydrate Amount at Each Meal in Children and Adolescents With Type 1 Diabetes Using the Carbohydrate Counting Method

Important dates

Study start: 2014
Primary completion: 2016
Study completion: 2016
First posted: Jan 29, 2015
Registry last updated: Jul 30, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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