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Completed

NCT Number: NCT03300934

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

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

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Key information

Conditions

Type1 Diabetes Mellitus

Age range

12 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Clinique des Enfants CHluxembourg

Luxembourg, 1210

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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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Treatment and study plan

closed loop glucose control system

Device

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

Primary outcomes

  1. Time spent in glucose target (%) (3.9 - 10 mmol/l)

    Time frame: 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 outcomes

  1. Time spent below glucose target (%) (<3.0mmol/l and < 2,5 mmol/l)

    Time frame: 4 week treatment arms

    Continuous blinded glucose monitoring during the study period with and without automated closed loop (%)

  2. Time spent above glucose target (%) (> 10 mmol/l)

    Time frame: 4 week treatment arms

    Continuous blinded glucose monitoring during the study period with and without automated closed loop (%)

  3. Severe hypoglycaemic events

    Time frame: 4 week treatment arms

    ISPAD Definition of severe hypoglycemia

  4. Severe Diabetes ketoacidosis

    Time frame: 4 week treatment arms

    ISPAD definition of severe DKA

  5. Use of the automated closed loop system (% time)

    Time frame: 4 week treatment arm

    % time , the system is used

  6. Use of the CGM during closed loop

    Time frame: 4 week treatment arm

    % time , the system is used

  7. Quality of life perception in adolescents

    Time frame: 4 week treatment periods

    Questionnaire based

  8. Family Responsibility perception

    Time frame: 4 week treatment periods

    Questionnaire based : Family responsibility scale

  9. User experience after the 4 week treatment

    Time frame: 4 week intervention

    questionnaire based

Sponsors and collaborators

Lead sponsor

Centre Hospitalier du Luxembourg

Other

Collaborators

  • Luxembourg Institute of Health
  • University of Cambridge

Registry information

Official study title

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

Acronym: SPIDIMAN2

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Oct 4, 2017
Registry last updated
Jul 31, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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