Type1 Diabetes Mellitus
Conditions
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.
Interventions
DEVICEclosed 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
Sponsors
University of Cambridge
Luxembourg Institute of Health
Centre Hospitalier du Luxembourg
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
12 Years to 18 Years
Healthy volunteers
No
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 \-
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Time spent in glucose target (%) (3.9 - 10 mmol/l) | 4 week treatment arms | Continuous blinded glucose monitoring during the study period with and without the automated Closed loop on a between arm comparison. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Time spent above glucose target (%) (> 10 mmol/l) | 4 week treatment arms | Continuous blinded glucose monitoring during the study period with and without automated closed loop (%) |
| Severe hypoglycaemic events | 4 week treatment arms | ISPAD Definition of severe hypoglycemia |
| Severe Diabetes ketoacidosis | 4 week treatment arms | ISPAD definition of severe DKA |
| Use of the automated closed loop system (% time) | 4 week treatment arm | % time , the system is used |
| Time spent below glucose target (%) (<3.0mmol/l and < 2,5 mmol/l) | 4 week treatment arms | Continuous blinded glucose monitoring during the study period with and without automated closed loop (%) |
| Quality of life perception in adolescents | 4 week treatment periods | Questionnaire based |
| Family Responsibility perception | 4 week treatment periods | Questionnaire based : Family responsibility scale |
| User experience after the 4 week treatment | 4 week intervention | questionnaire based |
| Use of the CGM during closed loop | 4 week treatment arm | % time , the system is used |
Countries
Luxembourg
Outcome results
None listed