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

Type1 Diabetes Mellitus Clinical Trial

— SPIDIMAN2  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03300934
• Other study ID #: Spidiman
• Status: Completed
• Phase: N/A
• Start date: July 1, 2017
• Est. completion date: July 19, 2018

Study information

• Verified date: July 2018
• Source: Centre Hospitalier du Luxembourg
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 16
• Est. completion date: July 19, 2018
• Est. primary completion date: July 19, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Years to 18 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 1
• Type1 Diabetes Mellitus

Intervention

Device:
• closed 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

Locations

Country	Name	City	State
Luxembourg	Clinique des Enfants CHluxembourg	Luxembourg

Sponsors (3)

Lead Sponsor	Collaborator
Centre Hospitalier du Luxembourg	Luxembourg Institute of Health, University of Cambridge

Country where clinical trial is conducted

Luxembourg, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	Severe hypoglycaemic events	ISPAD Definition of severe hypoglycemia	4 week treatment arms
Secondary	Severe Diabetes ketoacidosis	ISPAD definition of severe DKA	4 week treatment arms
Secondary	Use of the automated closed loop system (% time)	% time , the system is used	4 week treatment arm
Secondary	Use of the CGM during closed loop	% time , the system is used	4 week treatment arm
Secondary	Quality of life perception in adolescents	Questionnaire based	4 week treatment periods
Secondary	Family Responsibility perception	Questionnaire based : Family responsibility scale	4 week treatment periods
Secondary	User experience after the 4 week treatment	questionnaire based	4 week intervention