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

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ClinicalTrials.gov Identifier: NCT03882463
Recruitment Status : Unknown
Verified December 2019 by CHU de Reims.
Recruitment status was:  Recruiting
First Posted : March 20, 2019
Last Update Posted : December 16, 2019
Sponsor:
Information provided by (Responsible Party):
CHU de Reims

Study Description
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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 .


Condition or disease Intervention/treatment Phase
Diabetes Mellitus, Type 1 Device: Continuous glucose monitoring with the stop insulin pump function Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 32 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Interest of SmartGuard Technology (Predictive System for Stopping Insulin Before Hypoglycemia) in Children With Type 1 Diabetes Treated With Insulin Pump
Actual Study Start Date : April 30, 2019
Estimated Primary Completion Date : June 30, 2020
Estimated Study Completion Date : December 2020

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Arms and Interventions
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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".


Outcome Measures
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Primary Outcome Measures :
  1. Time spent hypoglycemia [ Time Frame: 1 month ]
    average daily time spent in hypoglycemia measured on a one-month data collection


Secondary Outcome Measures :
  1. Number of hypoglycemia [ Time Frame: 1 month ]
    Number of glycemia less than 0.70 g/l measured on a one-month data collection


Eligibility Criteria
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Ages Eligible for Study:   1 Year to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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%
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03882463


Contacts
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Contact: Pierre François SOUCHON 32678433 ext 0033 pfsouchon@chu-reims.fr

Locations
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France
Chu Reims Recruiting
France, Reims, France, 51092
Contact: Damien JOLLY    326788472 ext 33    djolly@chu-reims.fr   
Sponsors and Collaborators
CHU de Reims
More Information
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Responsible Party: CHU de Reims
ClinicalTrials.gov Identifier: NCT03882463    
Other Study ID Numbers: PO19026
First Posted: March 20, 2019    Key Record Dates
Last Update Posted: December 16, 2019
Last Verified: December 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 1
Hypoglycemia
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
 Autoimmune Diseases
Immune System Diseases
Insulin
Hypoglycemic Agents
Physiological Effects of Drugs