Diabetes Mellitus, Type 1NCT06185348
Body Mass Index and Growth Parameters Evolution in Children Treated With Hybrid Closed Loop System for Type 1 Diabetes
An observational study of Diabetes Mellitus, Type 1 and Obesity, run by Central Hospital, Nancy, France.
Trial summary
Overweigth and obesity are commonly diagnosed in children with type 1 diabetes, and frequently an increase of wiegth and BMI is observed after diagnoses. Hybrid cloosed loop system are new system where insulin is continually adapted to glycemia (using an algorythme). Read more about this study
- Who is it for?
- Ages 6 to 18 years
- Conditions the study is for
- Diabetes Mellitus, Type 1, Obesity, Overweight
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2024to 1 Nov 2025
- Phase
- Observational
- 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 6 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: children with type 1 diabetes follow up in Hospital of Nancy with HCL since 6 months minimum
Who may be able to join
- children between 6 and 18 years at the beginning of treatment with HCL
- type 1 diabetes
- follow up in University Hospital of Nancy between 01/01/2021 - 31/12/2023
- treatement with HCL since 6 months
Who cannot join
- parental opposition for the study
- pregnancy
Trial locations and contacts
No sites are listed yet.
About this study
Overweigth and obesity are commonly diagnosed in children with type 1 diabetes, and frequently an increase of wiegth and BMI is observed after diagnoses. Hybrid cloosed loop system are new system where insulin is continually adapted to glycemia (using an algorythme). The weight and growth trajectory of children treated with this system is poorly described.
Read the detailed description
Unlike type 2 diabetes, which is a frequent metabolic complication of obesity, type 1 diabetes is not a consequence of overweight or obesity, or of an excessively sweet or unbalanced diet.
However, more and more studies are linking type 1 diabetes to obesity. An international study with 23 026 children suffering from type 1 diabtes has shown that 22.3% of boys and 27.2% of children have overweight, and 6.8% and 6.3% respectively obesity . Several hypothesis are made to explain this trend : a consequence of intensive insulinotherapy, the fear of hypoglycemia with unnecessary glucose intake, the increase of caloric intake and the decrease of physcial activity. Moreover, subcutaneous insulinotherapy leads to modification in body composition with a increase in fat mass . Nevertheless, some studies highlights a possible role of obesity in the type 1 diabetes development( familial history of type 2 diabetes more common in children with type 1 diabetes , inverse relation with age at diagnosis and BMI suggesting that children with higher BMI will be diagnosed early in age .
Hybrid closed-loop systems, in which the insulin flow rate is adjusted almost instantaneously to the blood glucose level by using an algorithm with a CSII and a CGM, are new systems that have gradually been used in current practice . These systems are significantly associated with an improvement in glycemic control (HbA1C and TIR)[17], a reduction in the time spent in hypoglycemic states , and with an improvement in quality of life.
Nevertheless, the impact of this new treatment on weight evolution has been poorly described. A previous study with 50 children included did not show a BMI modification after 1 year of treatment. Individually, some patients following in our center have shown a reduction of BMI after treatment of type 1 diabetes with with hybrid closed loop system.
This leads us to perform an observational study in order to describe the trajectory of BMI and growth parameters of children suffering from type 1 diabetes (expressed in standard deviations (SDS) after 6 months, 1 year and 2 years of treatment with hybrid closed loop system in the university hospital of Nancy. The second objective is to identify potential factors associated with the positive evolution of BMI at 6 months, 1 year and 2 years.
- Conditions
- Diabetes Mellitus, Type 1, Obesity, Overweight, Child Obesity
- Medical subject headings
- Diabetes Mellitus, Type 1, Obesity, Overweight, Pediatric Obesity
What is being measured
The primary outcome is the main question the study is designed to answer.
Body mass index (BMI) variation after 6 months of treatment with hybrid closed loop (HCL)
variation of BMI expressed in standard deviations after 6 months with HCL
Measured: 6 months
Secondary outcomes (8)
Body mass index (BMI) variation after 12 months of treatment with hybrid closed loop (HCL)
variation of BMI expressed in standard deviations after 12 months with HCL
Measured: 12 months
Body mass index (BMI) variation after 24 months of treatment with hybrid closed loop (HCL)
variation of BMI expressed in standard deviations after 24 months with HCL
Measured: 24 months
Growth velocity variation after 6 months of treatment with hybrid closed loop (HCL)
variation of Growth velocity expressed in standard deviations after 6 months with HCL
Measured: 6 months
Growth velocity variation after 12 months of treatment with hybrid closed loop (HCL)
variation of Growth velocity expressed in standard deviations after 12 months with HCL
Measured: 12 months
Growth velocity variation after 24 months of treatment with hybrid closed loop (HCL)
variation of Growth velocity expressed in standard deviations after 24 months with HCL
Measured: 24 months
description of metabolic parameters at 6 months
HbA1C at 6 months
Measured: 6 months
description of metabolic parameters at 12 months
HbA1C at 12 months
Measured: 12 months
description of metabolic parameters at 24 months
HbA1C at 24months
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Dec 2023
- Study start1 Jan 2024 (estimated)
- Primary completion1 Nov 2024 (estimated)
- Study completion1 Nov 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes Mellitus, Type 1Studies of the same condition, open and under way.
- More trials run by Central Hospital, Nancy, FranceThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Central Hospital, Nancy, France
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, RENARD Emeline, Central Hospital, Nancy, France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06185348
- Sponsor's protocol ID
- 2023PI142
- Status last verified
- Dec 2023
- First submitted
- 12 Oct 2023
- Last updated
- 29 Dec 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Body Mass Index and Growth Parameters Evolution in Children Treated With Hybrid Closed Loop System for Type 1 Diabetes
- ClinicalTrials.gov ID
- NCT06185348
- Acronym / sponsor ID
- 2023PI142
- Conditions
- Diabetes Mellitus, Type 1, Obesity, Overweight, Child Obesity
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Central Hospital, Nancy, FranceUniversity, hospital or other
- Study start
- 1 Jan 2024 (estimated)
- Primary completion
- 1 Nov 2024 (estimated)
- Study completion
- 1 Nov 2025 (estimated)
- First posted
- 29 Dec 2023 (actual)
- 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.
Overweigth and obesity are commonly diagnosed in children with type 1 diabetes, and frequently an increase of wiegth and BMI is observed after diagnoses. Hybrid cloosed loop system are new system where insulin is continually adapted to glycemia (using an algorythme). The weight and growth trajectory of children treated with this system is poorly described.
Detailed description
Unlike type 2 diabetes, which is a frequent metabolic complication of obesity, type 1 diabetes is not a consequence of overweight or obesity, or of an excessively sweet or unbalanced diet.
However, more and more studies are linking type 1 diabetes to obesity. An international study with 23 026 children suffering from type 1 diabtes has shown that 22.3% of boys and 27.2% of children have overweight, and 6.8% and 6.3% respectively obesity . Several hypothesis are made to explain this trend : a consequence of intensive insulinotherapy, the fear of hypoglycemia with unnecessary glucose intake, the increase of caloric intake and the decrease of physcial activity. Moreover, subcutaneous insulinotherapy leads to modification in body composition with a increase in fat mass . Nevertheless, some studies highlights a possible role of obesity in the type 1 diabetes development( familial history of type 2 diabetes more common in children with type 1 diabetes , inverse relation with age at diagnosis and BMI suggesting that children with higher BMI will be diagnosed early in age .
Hybrid closed-loop systems, in which the insulin flow rate is adjusted almost instantaneously to the blood glucose level by using an algorithm with a CSII and a CGM, are new systems that have gradually been used in current practice . These systems are significantly associated with an improvement in glycemic control (HbA1C and TIR)[17], a reduction in the time spent in hypoglycemic states , and with an improvement in quality of life.
Nevertheless, the impact of this new treatment on weight evolution has been poorly described. A previous study with 50 children included did not show a BMI modification after 1 year of treatment. Individually, some patients following in our center have shown a reduction of BMI after treatment of type 1 diabetes with with hybrid closed loop system.
This leads us to perform an observational study in order to describe the trajectory of BMI and growth parameters of children suffering from type 1 diabetes (expressed in standard deviations (SDS) after 6 months, 1 year and 2 years of treatment with hybrid closed loop system in the university hospital of Nancy. The second objective is to identify potential factors associated with the positive evolution of BMI at 6 months, 1 year and 2 years.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 6 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- children with type 1 diabetes follow up in Hospital of Nancy with HCL since 6 months minimum
Key inclusion criteria (4 listed)
- children between 6 and 18 years at the beginning of treatment with HCL
- type 1 diabetes
- follow up in University Hospital of Nancy between 01/01/2021 - 31/12/2023
- treatement with HCL since 6 months
Key exclusion criteria (2 listed)
- parental opposition for the study
- pregnancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Body mass index (BMI) variation after 6 months of treatment with hybrid closed loop (HCL)
Time frame: 6 months
variation of BMI expressed in standard deviations after 6 months with HCL
8 secondary outcomes
Body mass index (BMI) variation after 12 months of treatment with hybrid closed loop (HCL)
Time frame: 12 months
Body mass index (BMI) variation after 24 months of treatment with hybrid closed loop (HCL)
Time frame: 24 months
Growth velocity variation after 6 months of treatment with hybrid closed loop (HCL)
Time frame: 6 months
Growth velocity variation after 12 months of treatment with hybrid closed loop (HCL)
Time frame: 12 months
Growth velocity variation after 24 months of treatment with hybrid closed loop (HCL)
Time frame: 24 months
description of metabolic parameters at 6 months
Time frame: 6 months
description of metabolic parameters at 12 months
Time frame: 12 months
description of metabolic parameters at 24 months
Time frame: 24 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Dec 2023.
- Individual participant dataSharing planned: No
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of Diabetes Mellitus, Type 1 and Obesity, run by Central Hospital, Nancy, 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 4 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 29 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact RENARD Emeline, PhD MD (0627647129, e_renard@hotmail.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Body mass index (BMI) variation after 6 months of treatment with hybrid closed loop (HCL) (time frame: 6 months). 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 29 Dec 2023.