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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Type1 Diabetes Mellitus

Intervention / Treatment
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* Device: closed loop glucose control system


Participation Criteria
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Eligibility Criteria
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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 -

Ages Eligible for Study
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Minimum Age: 12 Years
Maximum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: closed loop glucose control system<br>Closed loop glucose control system | Device: closed loop glucose control system<br>* Cross over between Closed loop glucose system with DANA pump, Navigator II CGM and Cambridge AP algorithm FD2A, versus usual CSII pump treatment<br>|
| No Intervention: CSII Pump treatment<br>CSII Pump treatment without the integrated algorithm and glucose sensor | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time spent in glucose target (%) (3.9 - 10 mmol/l) | Continuous blinded glucose monitoring during the study period with and without the automated Closed loop on a between arm comparison. | 4 week treatment arms | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time spent below glucose target (%) (<3.0mmol/l and < 2,5 mmol/l) | Continuous blinded glucose monitoring during the study period with and without automated closed loop (%) | 4 week treatment arms | 
| Time spent above glucose target (%) (> 10 mmol/l) | Continuous blinded glucose monitoring during the study period with and without automated closed loop (%) | 4 week treatment arms | 
| Severe hypoglycaemic events | ISPAD Definition of severe hypoglycemia | 4 week treatment arms | 
| Severe Diabetes ketoacidosis | ISPAD definition of severe DKA | 4 week treatment arms | 
| Use of the automated closed loop system (% time) | % time , the system is used | 4 week treatment arm | 
| Use of the CGM during closed loop | % time , the system is used | 4 week treatment arm | 
| Quality of life perception in adolescents | Questionnaire based | 4 week treatment periods | 
| Family Responsibility perception | Questionnaire based : Family responsibility scale | 4 week treatment periods | 
| User experience after the 4 week treatment | questionnaire based | 4 week intervention |