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

NCT ID: NCT03300934

Last Updated: 2018-07-31

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 16 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-07-01
• Study Completion Date: 2018-07-19

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.

Conditions

Type1 Diabetes Mellitus

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

closed loop glucose control system

Closed loop glucose control system

Group Type: EXPERIMENTAL

closed loop glucose control system

Intervention Type: DEVICE

Cross over between Closed loop glucose system with DANA pump, Navigator II CGM and Cambridge AP algorithm FD2A, versus usual CSII pump treatment

CSII Pump treatment

CSII Pump treatment without the integrated algorithm and glucose sensor

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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

Intervention Type: DEVICE

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

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• Minimum Eligible Age: 12 Years
• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Cambridge

OTHER

Sponsor Role: collaborator

Luxembourg Institute of Health

OTHER_GOV

Sponsor Role: collaborator

Centre Hospitalier du Luxembourg

OTHER

Sponsor Role: lead

Responsible Party

Carine de Beaufort

Guest professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Carine de Beaufort, MD PhD

Role: PRINCIPAL_INVESTIGATOR

Centre Hospitalier du Luxembourg

Locations

Clinique des Enfants CHluxembourg

Luxembourg, , Luxembourg

Countries

Luxembourg

Other Identifiers

Spidiman

Identifier Type: -

Identifier Source: org_study_id