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Carbohydrate Counting in Children and Adolescents With Type 1 Diabetes

Primary Purpose

Type 1 Diabetes

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
carbohydrate counting
Sponsored by
Fondation Lenval
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Type 1 Diabetes focused on measuring diabetes, children

Eligibility Criteria

1 Year - 18 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Fondation Lenval

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

carbohydrate counting

Arm Description

patients must fill their logbook during 28 days

Outcomes

Primary Outcome Measures

The individual variation of CHO amount at each main meal : Breakfast, Lunch, Snacks, Dinner
the patients must fill their logbook during 28 days

Secondary Outcome Measures

Full Information

First Posted
January 16, 2015
Last Updated
July 27, 2018
Sponsor
Fondation Lenval
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1. Study Identification

Unique Protocol Identification Number
NCT02350374
Brief Title
Carbohydrate Counting in Children and Adolescents With Type 1 Diabetes
Official 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
Study Type
Interventional

2. Study Status

Record Verification Date
July 2018
Overall Recruitment Status
Completed
Study Start Date
November 17, 2014 (Actual)
Primary Completion Date
May 17, 2016 (Actual)
Study Completion Date
May 17, 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Fondation Lenval

4. Oversight

Data Monitoring Committee
No

5. Study Description

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
Detailed Description
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 1 Diabetes
Keywords
diabetes, children

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
82 (Actual)

8. Arms, Groups, and Interventions

Arm Title
carbohydrate counting
Arm Type
Other
Arm Description
patients must fill their logbook during 28 days
Intervention Type
Other
Intervention Name(s)
carbohydrate counting
Intervention Description
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 Outcome Measure Information:
Title
The individual variation of CHO amount at each main meal : Breakfast, Lunch, Snacks, Dinner
Description
the patients must fill their logbook during 28 days
Time Frame
each day during 28 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
1 Year
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marie HOFLACK, PhD
Organizational Affiliation
Fondation Lenval
Official's Role
Principal Investigator
Facility Information:
Facility Name
Fondation Lenval
City
Nice
ZIP/Postal Code
06200
Country
France

12. IPD Sharing Statement

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Carbohydrate Counting in Children and Adolescents With Type 1 Diabetes

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