Diabetes Mellitus, Type 1
Conditions
Brief summary
Management of children and adolescents with type 1 diabetes is essentially insulin therapy using insulin pump, allowing the improvement of the glycemic balance. However, the risk of hypoglycaemia inherent to the treatment persists. Hypoglycemia is an acute complication in the management of diabetes. It can be manifested by warning signs (tremors, sweats, feelings of hunger ...) but also occur during sleep and be ignored. It can be responsible for asthenia, difficulty concentrating and attention and memory problems. In order to decrease time spent in hypoglycemia, insulin pump therapy can be coupled with a continuous glucose measurement system with a stop insulin pump function in case of hypoglycemia. The aim of the study is to evaluate efficacy of the predictive system for stopping before hypoglycaemia medtronic Minimed with SmartGuard technology in type 1 diabetic children, especially on the time spent in hypoglycemia .
Detailed description
Management of children and adolescents with type 1 diabetes is essentially insulin therapy using insulin pump, allowing the improvement of the glycemic balance. However, the risk of hypoglycaemia inherent to the treatment persists. Hypoglycemia is an acute complication in the management of diabetes. It can be manifested by warning signs (tremors, sweats, feelings of hunger ...) but also occur during sleep and be ignored. It can be responsible for asthenia, difficulty concentrating and attention and memory problems. In order to decrease time spent in hypoglycemia, insulin pump therapy can be coupled with a continuous glucose measurement system with a stop insulin pump function in case of hypoglycemia. The aim of the study is to evaluate efficacy of the predictive system for stopping before hypoglycaemia medtronic Minimed with SmartGuard technology in type 1 diabetic children, especially on the time spent in hypoglycemia .
Interventions
DEVICEContinuous glucose monitoring with the stop insulin pump function
Children with type 1 diabetes using insulin pump and continuous glucose monitoring without the stop insulin pump functionare then using the predictive system for stopping before hypoglycaemia medtronic Minimed with SmartGuard technology.
Sponsors
CHU de Reims
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
1 Years to 17 Years
Healthy volunteers
No
Inclusion criteria
: * children aged between 1 and 17 years * type 1 diabetes * Duration of type 1 diabetes \> 1 year * insulin pump therapy \> 3 months
Exclusion criteria
: * Other diseases predisposing to hypoglycemia * Oral glycemic medications * have used continuous glucose monitoring during the last 3 months * HbA1c \>10%
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Time spent hypoglycemia | 1 month | average daily time spent in hypoglycemia measured on a one-month data collection |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of hypoglycemia | 1 month | Number of glycemia less than 0.70 g/l measured on a one-month data collection |
Countries
France
Outcome results
None listed