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Clinical Trials/NCT03882463
NCT03882463
Completed
Not Applicable

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

CHU de Reims1 site in 1 country34 target enrollmentApril 30, 2019

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Diabetes Mellitus, Type 1
Sponsor
CHU de Reims
Enrollment
34
Locations
1
Primary Endpoint
Time spent hypoglycemia
Status
Completed
Last Updated
3 years ago

Overview

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 .

Registry
clinicaltrials.gov
Start Date
April 30, 2019
End Date
December 31, 2021
Last Updated
3 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Not provided

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

Time spent hypoglycemia

Time Frame: 1 month

average daily time spent in hypoglycemia measured on a one-month data collection

Secondary Outcomes

  • Number of hypoglycemia(1 month)

Study Sites (1)

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