Interest of SmartGuard Technology (Predictive System for Stopping Insulin Before Hypoglycemia) in Children With Type 1 Diabetes Treated With Insulin Pump

CHU de Reims

Status: Completed

Conditions: Diabetes Mellitus, Type 1

Treatments: Device: Continuous glucose monitoring with the stop insulin pump function

Study type: Interventional

Funder types: Other

Identifiers

NCT03882463

PO19026*

Details and patient eligibility

About

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 .

Full 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 .

Enrollment: 34 patients

Sex: All

Ages: 1 to 17 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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%

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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34 participants in 1 patient group

insulin pump function

Experimental group

Description:

continuous glucose monitoring and then continuous glucose monitoring with the stop insulin pump function

Treatment:

Device: Continuous glucose monitoring with the stop insulin pump function