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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT06185348
Other study ID # 2023PI142
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
Start date January 1, 2024
Est. completion date November 1, 2025

Study information

Verified date December 2023
Source Central Hospital, Nancy, France
Contact RENARD Emeline, PhD MD
Phone 0627647129
Email e_renard@hotmail.fr
Is FDA regulated No
Health authority
Study type Observational

Clinical 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). The weight and growth trajectory of children treated with this system is poorly described.


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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 60
Est. completion date November 1, 2025
Est. primary completion date November 1, 2024
Accepts healthy volunteers No
Gender All
Age group 6 Years to 18 Years
Eligibility 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 Design


Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Central Hospital, Nancy, France

Outcome

Type Measure Description Time frame Safety issue
Primary 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 6 months
Secondary 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 12 months
Secondary 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 24 months
Secondary 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 6 months
Secondary 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 12 months
Secondary 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 24 months
Secondary description of metabolic parameters at 6 months HbA1C at 6 months 6 months
Secondary description of metabolic parameters at 12 months HbA1C at 12 months 12 months
Secondary description of metabolic parameters at 24 months HbA1C at 24months 24 months
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