Diabetes Mellitus, Type 1, Pediatric ALL
Conditions
Brief summary
More than half of type 1 diabetes (DT1) children are under CSII (Continuous Subcutaneous Insulin Infusion). Several studies showed that despite a patients' follow-up mostly by hospital-based paediatricians, there are still some concerns on long-term glycaemic control with inconstant results on glycaemic control either due to CSII adherence or nutrition management issues. Consequently, this real life study aims to compare two monitoring methods (standard versus intensive) in children initiating a CSII treatment and assess the impact on glycaemic control after one year.
Detailed description
As CSII becomes more and more the gold standard therapy in children with type 1 diabetes, there have been some questions regarding the long-term effect of these treatments with some concerns on the inconstant results on glycaemic control either due to CSII adherence or nutrition management issues. The DCCT (Diabetes Control and Complications Trial) study has already shown in diabetic adults that intensification of treatment and follow-up could result in significative improvement of glycaemic control. This study aims to test this hypothesis of significant improvement after one year following CSII initiation on glycaemic control. Two parallel arms will be compared in real life conditions; one with standard recommendations-based follow-up by both diabetologists/pediatricians and service provider and the other with intensive follow-up with higher frequency of provider's nurses visits and personalization of patient status transferred to the physician for each diabetologists/pediatricians visit. Thus, investigators could determine after one year if the glycaemic control is better with one or the other of these follow-up procedures. Glycaemic control will be assessed both by the evolution of HbA1c during the study period and its last level at the end of the study. Its evaluation will be completed by counting of all symptomatic hypoglycemia occurence during the study.
Interventions
BEHAVIORALMonitoring of the patients
Follow-up of the patients during the 12 months study periods including : * visits with the diabetologist/pediatrician * contacts with the service provider (nurses' visits) (more in intensive group) * personalized monitoring of glycemic data transferred to the diabetologist/pediatrician for each visit (only in intensive group)
Sponsors
ISIS Diabete Service
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Intervention model description
Prospective randomized parallel groups open study
Eligibility
Sex/Gender
ALL
Age
12 Months to 17 Years
Healthy volunteers
No
Inclusion criteria
* Children (\<18 yo) with not controlled type 1 diabetes seen by diabetologists/paediatricians immediately following the initiation of CSII. * Children for whom it is the first initiation of CSII. * Children (or their parents if necessary) having read the information note and having dated and signed the informed consent form.
Exclusion criteria
* Children with a history of diabetes less than 12 months. * Children with HbA1c values below 7.5 or above 10 before CSII initiation. * Children treated by CSII for more than 3 months.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Impact on glycaemic control one year after CSII initiation | HbA1c values at inclusion and last known measurement at the 12 months last visit | Evolution of HbA1c measurement between last measure before CSII initiation and 12 months after. |
| Impact on glycaemic control all along the study | Assessment and counting of all unplanned hospitalizations during the 12 months period | Unplanned hospitalization rate during the study Severe hypoglycemia during the study period |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Impact on glycaemic control upon age classes | HbA1c values at inclusion and last known measurement at the 12 months last visit | sub-groups based one age (\<7 years old \[yo\], 7-12 yo, 13-17 yo) |
Countries
France
Contacts
Primary ContactArnaud Jerome, PhD
Backup ContactAlix Geissler, PhD
Outcome results
None listed