Carbohydrate Counting in Children and Adolescents With Type 1 Diabetes
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
1 other identifier
interventional
82
1 country
1
Brief Summary
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Nov 2014
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
November 17, 2014
CompletedFirst Submitted
Initial submission to the registry
January 16, 2015
CompletedFirst Posted
Study publicly available on registry
January 29, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 17, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
May 17, 2016
CompletedJuly 30, 2018
July 1, 2018
1.5 years
January 16, 2015
July 27, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
The individual variation of CHO amount at each main meal : Breakfast, Lunch, Snacks, Dinner
the patients must fill their logbook during 28 days
each day during 28 days
Study Arms (1)
carbohydrate counting
OTHERpatients must fill their logbook during 28 days
Interventions
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
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Fondation Lenvallead
Study Sites (1)
Fondation Lenval
Nice, 06200, France
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Marie HOFLACK, PhD
Fondation Lenval
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- OTHER
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 16, 2015
First Posted
January 29, 2015
Study Start
November 17, 2014
Primary Completion
May 17, 2016
Study Completion
May 17, 2016
Last Updated
July 30, 2018
Record last verified: 2018-07