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QUality of Control and slEep in Children With diabeteS, Using New Technology

NCT03103867 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 32

Last updated 2018-08-03

No results posted yet for this study

Summary

The study is an open label single centre randomised cross over study to evaluate the impact of a sensor augmented pump (SAP) with a predictive algorithm to suspend temporarily insulin administration (640G® with the Smart Guard feature) versus the use of the same pump for insulin administration with 'only' continuous glucose measurements (not interacting with the pump, Freestyle Libre ® ) on the time in glucose target , in hypo- and hyperglycemia. Exploratory endpoints are the effect on sleep and quality of life in children with type 1 diabetes and their caregivers.

Conditions

  • Diabetes Mellitus, Type 1

Interventions

DEVICE

CGM augmented pump with PLGS ,

5 weeks treatment CGM augmented pump with PLGS compared with 5 weeks treatment with insulin pump with CGM , without integration

DEVICE

Insulin pump with CGM

5 weeks treatment continuous subcutaneous insulin infusion pump with CGM without data integration,

Sponsors & Collaborators

  • Centre Hospitalier du Luxembourg

    lead OTHER

Principal Investigators

  • Carine de Beaufort, MD,PhD · Centre Hospitalier du Luxembourg

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
6 Years
Max Age
14 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-02-23
Primary Completion
2018-05-04
Completion
2018-07-15
FDA Device
Yes

Countries

  • Luxembourg

Study Locations

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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 NCT03103867 on ClinicalTrials.gov