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

Diabetes Mellitus, Type 1 Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03882463
• Other study ID #: PO19026*
• Status: Completed
• Phase: N/A
• Start date: April 30, 2019
• Est. completion date: December 31, 2021

Study information

• Verified date: May 2022
• Source: CHU de Reims
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 .

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 .

Recruitment information / eligibility

• Status: Completed
• Enrollment: 34
• Est. completion date: December 31, 2021
• Est. primary completion date: April 18, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 1 Year to 17 Years

Eligibility

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%

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 1
• Hypoglycemia

Intervention

Device:
• Continuous 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".

Locations

Country	Name	City	State
France	Chu Reims	Reims

Sponsors (1)

Lead Sponsor	Collaborator
CHU de Reims

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time spent hypoglycemia	average daily time spent in hypoglycemia measured on a one-month data collection	1 month
Secondary	Number of hypoglycemia	Number of glycemia less than 0.70 g/l measured on a one-month data collection	1 month