ClinicalTrials.Veeva

Menu

Safety and Efficacy of Overnight Closed Loop in Children With Type 1Diabetes Mellitus in Luxembourg

C

Centre Hospitalier du Luxembourg

Status

Completed

Conditions

Type 1 Diabetes Mellitus

Treatments

Device: FLORENCED2

Study type

Interventional

Funder types

Other

Identifiers

NCT02099409
SPIDLUX 4

Details and patient eligibility

About

The purpose of this study is to validate current algorithms and evaluate safety and efficacy of overnight closed loop insulin delivery (FlorenceD2 system) in children with type 1 diabetes between 6 - 12 years of age in Luxembourg .

Enrollment

15 patients

Sex

All

Ages

6 to 12 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Between 6 - ≤12 years
  • With type 1 diabetes for 6 months or more and
  • Pump user for at least 6 months.
  • HbAc1 should be <11 %.
  • No medication or physical or psychological disease should be present, which could interfere with the study.

Exclusion criteria

-None

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

None (Open label)

15 participants in 2 patient groups

Starting with FLORENCED2 followed by open loop
Experimental group
Description:
Start 2 Overnight periods with closed loop through FLORENCED2 Device , followed by 2 overnight periods with open loop.
Treatment:
Device: FLORENCED2
Start open loop followed by FLORENCED2
Experimental group
Description:
Start with 2 overnight periods with open loop , followed by 2 overnight with closed loop FLORENCED2
Treatment:
Device: FLORENCED2

Trial contacts and locations

2

Loading...

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2024 Veeva Systems