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.
