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

Not Applicable

Completed

• Conditions: Type1 Diabetes Mellitus

• Registration Number: NCT03300934
• Lead Sponsor: Centre Hospitalier du Luxembourg

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.

Study Timeline

• Study Start: 2017-07-01
• Study First Submitted: 2017-09-29
• Study First Submitted QC: 2017-09-29
• Study First Posted: 2017-10-04
• Status Verified: 2018-07
• Primary Completion: 2018-07-19
• Study Completion: 2018-07-19
• Last Update Submitted: 2018-07-29
• Last Update Posted: 2018-07-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 16

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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 (%)
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 (%)
Use of the CGM during closed loop	4 week treatment arm	% time , the system is used
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

Trial Locations

Locations (1)

Clinique des Enfants CHluxembourg; 🇱🇺 Luxembourg, Luxembourg