Viewing Study NCT06185348



Ignite Creation Date: 2024-05-06 @ 7:56 PM
Last Modification Date: 2024-10-26 @ 3:16 PM
Study NCT ID: NCT06185348
Status: NOT_YET_RECRUITING
Last Update Posted: 2023-12-29
First Post: 2023-10-12

Brief Title: Body Mass Index and Growth Parameters Evolution in Children Treated With Hybrid Closed Loop System for Type 1 Diabetes
Sponsor: Central Hospital Nancy France
Organization: Central Hospital Nancy France

Study Overview

Official Title: Body Mass Index and Growth Parameters Evolution in Children Treated With Hybrid Closed Loop System for Type 1 Diabetes
Status: NOT_YET_RECRUITING
Status Verified Date: 2023-12
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
Brief 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 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 223 of boys and 272 of children have overweight and 68 and 63 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 TIR17 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 Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: False
Is a FDA Regulated Device?: False
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None