Clinical trial NCT03300934: Adolescence and Diabetes:Can an Automated Closed Loop System Improve Control ?
Official title: Adolescence and Diabetes: Can an Automated Closed Loop System Improve Control ?
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Type1 Diabetes Mellitus
Lead sponsor: Centre Hospitalier du Luxembourg
Sponsor class: OTHER
Collaborators: name: University of Cambridge
name: Luxembourg Institute of Health
First posted: 2017-10-04
Enrollment: 16
Sex: ALL
Minimum age (years): 12
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief 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.

Eligibility criteria: Inclusion Criteria:

12- 18 years Type 1 diabetes according to WHO/ISPAD , for at least 1 year CSII treatment for at least 6 month HbA1c ≥ 8,0%, for more than 6 months Informed consent of the patient and parents

Exclusion Criteria:

Non-type 1 diabetes mellitus including those secondary to chronic disease Any other physical or psychological disease or condition likely to interfere with the normal conduct of the study and interpretation of the study results as judged by the investigator.

Current treatment with drugs known to have significant interference with glucose metabolism, such as systemic corticosteroids, as judged by the investigator Known or suspected allergy against insulin Recurrent incidents of severe hypoglycaemia as defined by ISPAD guidelines during the previous 12 months.

More than one episode of diabetic ketoacidosis (DKA) as defined by ISPAD in preceding 12 months

-

Primary outcomes:
measure: Time spent in glucose target (%) (3.9 - 10 mmol/l)
timeFrame: 4 week treatment arms
Secondary outcomes:
measure: Time spent below glucose target (%) (<3.0mmol/l and < 2,5 mmol/l)
timeFrame: 4 week treatment arms
measure: Time spent above glucose target (%) (> 10 mmol/l)
timeFrame: 4 week treatment arms
measure: Severe hypoglycaemic events
timeFrame: 4 week treatment arms
measure: Severe Diabetes ketoacidosis
timeFrame: 4 week treatment arms
measure: Use of the automated closed loop system (% time)
timeFrame: 4 week treatment arm
measure: Use of the CGM during closed loop
timeFrame: 4 week treatment arm
measure: Quality of life perception in adolescents
timeFrame: 4 week treatment periods
measure: Family Responsibility perception
timeFrame: 4 week treatment periods
measure: User experience after the 4 week treatment
timeFrame: 4 week intervention
Other outcomes:
Locations:
city: Luxembourg
country: Luxembourg
facility: Clinique des Enfants CHluxembourg
Study officials:
affiliation: Centre Hospitalier du Luxembourg
name: Carine de Beaufort, MD PhD
role: PRINCIPAL_INVESTIGATOR
References: