Type 1 DiabetesNCT02350374
Carbohydrate Counting in Children and Adolescents With Type 1 Diabetes
A study testing carbohydrate counting in people with Type 1 Diabetes, run by Fondation Lenval at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 1 year to 18 years
- Conditions the study is for
- Type 1 Diabetes
- What is being tested?
- carbohydrate counting
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 82 participants
- Where
- 1 siteFrance
- Study dates
- 17 Nov 2014to 17 May 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 year to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
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
Read the 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
- Conditions
- Type 1 Diabetes
- Being tested
- carbohydrate counting
- Keywords
- diabetes, children
- Medical subject headings
- Diabetes Mellitus, Type 1, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
carbohydrate countingOther
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
| Study group | Role | What they receive |
|---|---|---|
| carbohydrate counting | Other | patients must fill their logbook during 28 days Receives: Other: carbohydrate counting |
What is being measured
The primary outcome is the main question the study is designed to answer.
The individual variation of CHO amount at each main meal : Breakfast, Lunch, Snacks, Dinner
the patients must fill their logbook during 28 days
Measured: each day during 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jan 2015 (estimated)
- Study start17 Nov 2014
- Primary completion17 May 2016
- Study completion17 May 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 1 DiabetesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 82 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fondation Lenval
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Marie HOFLACK, PhD, Principal investigator, Fondation Lenval
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02350374
- Sponsor's protocol ID
- 14-HPNCL-05
- Status last verified
- Jul 2018
- First submitted
- 16 Jan 2015
- Last updated
- 30 Jul 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02350374
- Acronym / sponsor ID
- 14-HPNCL-05
- Conditions
- Type 1 Diabetes
- Keywords
- diabetes, children
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 82 participants (actual)
- Lead sponsor
- Fondation LenvalUniversity, hospital or other
- Study start
- 17 Nov 2014 (actual)
- Primary completion
- 17 May 2016 (actual)
- Study completion
- 17 May 2016 (actual)
- First posted
- 29 Jan 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| carbohydrate counting | Other | Other: carbohydrate countingpatients must fill their logbook during 28 days |
Who may qualify
- Ages
- 1 year to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| carbohydrate countingpatients must fill their logbook with the following data: * cho amount at breakfast, lunch, snack and dinner * insulin amount at breakfast, lunch, snack and dinner | Other | carbohydrate counting |
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jul 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marie HOFLACK, PhD principal investigator
Fondation Lenval
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing carbohydrate counting in people with Type 1 Diabetes, run by Fondation Lenval at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The individual variation of CHO amount at each main meal : Breakfast, Lunch, Snacks, Dinner (time frame: each day during 28 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jul 2018.