Body Mass Index and Growth Parameters Evolution in Children Treated With Hybrid Closed Loop System for Type 1 Diabetes

December 14, 2023 updated by: RENARD Emeline, Central Hospital, Nancy, France
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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
60

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Child
  • Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

children with type 1 diabetes follow up in Hospital of Nancy with HCL since 6 months minimum

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • parental opposition for the study
  • pregnancy

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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
6 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Body mass index (BMI) variation after 12 months of treatment with hybrid closed loop (HCL)
Time Frame: 12 months
variation of BMI expressed in standard deviations after 12 months with HCL
12 months
Body mass index (BMI) variation after 24 months of treatment with hybrid closed loop (HCL)
Time Frame: 24 months
variation of BMI expressed in standard deviations after 24 months with HCL
24 months
Growth velocity variation after 6 months of treatment with hybrid closed loop (HCL)
Time Frame: 6 months
variation of Growth velocity expressed in standard deviations after 6 months with HCL
6 months
Growth velocity variation after 12 months of treatment with hybrid closed loop (HCL)
Time Frame: 12 months
variation of Growth velocity expressed in standard deviations after 12 months with HCL
12 months
Growth velocity variation after 24 months of treatment with hybrid closed loop (HCL)
Time Frame: 24 months
variation of Growth velocity expressed in standard deviations after 24 months with HCL
24 months
description of metabolic parameters at 6 months
Time Frame: 6 months
HbA1C at 6 months
6 months
description of metabolic parameters at 12 months
Time Frame: 12 months
HbA1C at 12 months
12 months
description of metabolic parameters at 24 months
Time Frame: 24 months
HbA1C at 24months
24 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Central Hospital, Nancy, France

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 1, 2024

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 1, 2024

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 1, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 12, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 14, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 29, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 29, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 14, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2023PI142

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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