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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

Primary Purpose

Diabetes Mellitus, Type 1

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Continuous glucose monitoring with the stop insulin pump function
Sponsored by
CHU de Reims
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diabetes Mellitus, Type 1

Eligibility Criteria

1 Year - 17 Years (Child)All SexesDoes not accept healthy volunteers

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%

Sites / Locations

  • Chu Reims

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

insulin pump function

Arm Description

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Number of hypoglycemia
Number of glycemia less than 0.70 g/l measured on a one-month data collection

Full Information

First Posted
March 18, 2019
Last Updated
May 20, 2022
Sponsor
CHU de Reims
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1. Study Identification

Unique Protocol Identification Number
NCT03882463
Brief Title
Interest of SmartGuard Technology (Predictive System for Stopping Insulin Before Hypoglycemia) in Children With Type 1 Diabetes Treated With Insulin Pump
Official Title
Interest of SmartGuard Technology (Predictive System for Stopping Insulin Before Hypoglycemia) in Children With Type 1 Diabetes Treated With Insulin Pump
Study Type
Interventional

2. Study Status

Record Verification Date
May 2022
Overall Recruitment Status
Completed
Study Start Date
April 30, 2019 (Actual)
Primary Completion Date
April 18, 2021 (Actual)
Study Completion Date
December 31, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
CHU de Reims

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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 .

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus, Type 1

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
34 (Actual)

8. Arms, Groups, and Interventions

Arm Title
insulin pump function
Arm Type
Experimental
Arm Description
continuous glucose monitoring and then continuous glucose monitoring with the stop insulin pump function
Intervention Type
Device
Intervention Name(s)
Continuous glucose monitoring with the stop insulin pump function
Intervention Description
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".
Primary Outcome Measure Information:
Title
Time spent hypoglycemia
Description
average daily time spent in hypoglycemia measured on a one-month data collection
Time Frame
1 month
Secondary Outcome Measure Information:
Title
Number of hypoglycemia
Description
Number of glycemia less than 0.70 g/l measured on a one-month data collection
Time Frame
1 month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
1 Year
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
Eligibility 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%
Facility Information:
Facility Name
Chu Reims
City
Reims
ZIP/Postal Code
51092
Country
France

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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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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