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Impact of the Use of a Closed-loop Insulin Therapy on the Burden of the Diabetes and the Quality of Life

NCT04939766 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 250

Last updated 2021-06-25

No results posted yet for this study

Summary

The use by diabetes patients of real-time Continuous Glucose Monitoring (CGM) system is becoming widespread and has changed diabetic practice. Automated closed-loop (CL) insulin therapy has come of age. This major technological advance is expected to significantly improve the quality of care for adults, adolescents and children with type 1 diabetes.

Questions remain about patients' perception and acceptance on this automatisation of the management of their glycemic variability.

Thus this study is built to evaluate the impact of the activation of the closed-loop on quality of life and burden of their diabetes in patients with type 1 diabetes under CSII.

Conditions

  • Quality of Life
  • Burden, Dependency

Interventions

DEVICE

Activation of a closed loop device in an insulin pump device with GCM

After a run-in period of 20 days to co,firm eligibility, the closed loop is activated and patients are followed for 6 months by their diabetologists.

Sponsors & Collaborators

  • VitalAire

    lead INDUSTRY

Principal Investigators

  • Yves Reznik, MD PHD · University Hospital, Caen

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
13 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-06-30
Primary Completion
2022-09-30
Completion
2022-12-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04939766 on ClinicalTrials.gov