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

NCT03882463 | Completed

• 1 other identifier: PO19026*
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

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 .

Conditions

Diabetes Mellitus, Type 1

Outcome Measures

Primary Outcomes (1)

• Time spent hypoglycemia

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

  1 month

Secondary Outcomes (1)

• Number of hypoglycemia

  1 month

Study Arms (1)

insulin pump function

EXPERIMENTAL

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

Device: Continuous glucose monitoring with the stop insulin pump function

Interventions

Continuous glucose monitoring with the stop insulin pump function DEVICE

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".

insulin pump function

Eligibility Criteria

• Age: 1 Year - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• children aged between 1 and 17 years
• type 1 diabetes
• Duration of type 1 diabetes \> 1 year
• insulin pump therapy \> 3 months

You may not qualify if:

• Other diseases predisposing to hypoglycemia
• Oral glycemic medications
• have used continuous glucose monitoring during the last 3 months
• HbA1c \>10%

Sponsors & Collaborators

• CHU de Reims: lead

Study Sites (1)

Chu Reims

Reims, 51092, France

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Interventions

Continuous Glucose Monitoring

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Blood Chemical Analysis; Clinical Chemistry Tests; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Diagnostic Techniques, Endocrine; Monitoring, Physiologic; Investigative Techniques

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 18, 2019
• First Posted: March 20, 2019
• Study Start: April 30, 2019
• Primary Completion: April 18, 2021
• Study Completion: December 31, 2021
• Last Updated: May 23, 2022

Record last verified: 2022-05

Locations

FR (1)