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

May 20, 2022 updated by: CHU de Reims

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 .

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 .

Study Type

Interventional

Enrollment (Actual)

34

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Reims, France, 51092
        • CHU Reims

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 year to 17 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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%

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: insulin pump function
continuous glucose monitoring and then continuous glucose monitoring with the stop insulin pump function
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".

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time spent hypoglycemia
Time Frame: 1 month
average daily time spent in hypoglycemia measured on a one-month data collection
1 month

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of hypoglycemia
Time Frame: 1 month
Number of glycemia less than 0.70 g/l measured on a one-month data collection
1 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

CHU de Reims

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 30, 2019

Primary Completion (Actual)

April 18, 2021

Study Completion (Actual)

December 31, 2021

Study Registration Dates

First Submitted

March 18, 2019

First Submitted That Met QC Criteria

March 18, 2019

First Posted (Actual)

March 20, 2019

Study Record Updates

Last Update Posted (Actual)

May 23, 2022

Last Update Submitted That Met QC Criteria

May 20, 2022

Last Verified

May 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PO19026*

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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