NCT03300934

Adolescence and Diabetes:Can an Automated Closed Loop System Improve Control ?

Adolescence and Diabetes: Can an Automated Closed Loop System Improve Control ?

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 16 (actual)
• Sponsor: Centre Hospitalier du Luxembourg · Academic / Other
• Sex: All
• Age: 12 Years – 18 Years
• Healthy volunteers: Not accepted

Summary

This study evaluates the use of the FD2 automated closed loop insulin administration in Adolescents with a poor metabolic control . All youth will be treated in a random order by their usual pump treatment or an Automated system and we will evaluate whether this has an impact on metabolic control and sleep

Detailed description

Achievement of a good metabolic control is very important for all persons with diabetes . In adolescence many changes occur , physically , socially and psychologically .This may influence the metabolic control . This study will evaluate whether the automated closed-loop will facilitate and improve the management of diabetes in youth with a poor metabolic control. It is a single-centre, randomised, two-period crossover study to assess the efficacy /safety and acceptability of the automated closed-loop glucose control (CL) day and night, over 28 days in comparison with continuous subcutaneous insulin infusion (CSII) in the home setting in poorly controlled type 1 diabetes adolescents.

Conditions

• Type1 Diabetes Mellitus

Interventions

Type	Name	Description
DEVICE	closed loop glucose control system	Cross over between Closed loop glucose system with DANA pump, Navigator II CGM and Cambridge AP algorithm FD2A, versus usual CSII pump treatment

Timeline

• Start date: 2017-07-01
• Primary completion: 2018-07-19
• Completion: 2018-07-19
• First posted: 2017-10-04
• Last updated: 2018-07-31

Locations

1 site across 1 country: Luxembourg