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Adolescence and Diabetes:Can an Automated Closed Loop System Improve Control ? (SPIDIMAN2)

This study is currently recruiting participants.
Verified September 2017 by Carine de Beaufort, Centre Hospitalier du Luxembourg
Sponsor:
ClinicalTrials.gov Identifier:
NCT03300934
First Posted: October 4, 2017
Last Update Posted: October 4, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Collaborators:
University of Cambridge
Luxembourg Institute of Health
Information provided by (Responsible Party):
Carine de Beaufort, Centre Hospitalier du Luxembourg
  Purpose
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

Condition Intervention
Type1 Diabetes Mellitus Device: automated closed loop glucose control

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Adolescence and Diabetes: Can an Automated Closed Loop System Improve Control ?

Resource links provided by NLM:


Further study details as provided by Carine de Beaufort, Centre Hospitalier du Luxembourg:

Primary Outcome Measures:
  • 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 Outcome Measures:
  • 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 (%)

  • 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 (%)

  • Severe hypoglycaemic events [ Time Frame: 4 week treatment arms ]
    ISPAD Definition of severe hypoglycemia

  • Severe Diabetes ketoacidosis [ Time Frame: 4 week treatment arms ]
    ISPAD definition of severe DKA

  • Use of the automated closed loop system (% time) [ Time Frame: 4 week treatment arm ]
    % time , the system is used

  • Use of the CGM during closed loop [ Time Frame: 4 week treatment arm ]
    % time , the system is used

  • Quality of life perception in adolescents [ Time Frame: before and after both 4 week treatment periods ]
    Questionnaire based

  • Family Responsibility perception [ Time Frame: before and after both 4 week treatment periods ]
    Questionnaire based : Family responsibility scale

  • User experience after the 4 week treatment [ Time Frame: after 4 week intervention ]
    questionnaire based


Estimated Enrollment: 14
Actual Study Start Date: July 1, 2017
Estimated Study Completion Date: September 1, 2018
Estimated Primary Completion Date: July 1, 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: automated closed-loop glucose control
FreeStyle Navigator II® Continuous Glucose Monitoring (CGM) System (Abbott Diabetes Care, Alameda, CA, USA), DANA Diabecare R subcutaneous insulin pump (SOOIL Development co, Seoul, Korea) and a MPC-based glucose control algorithm running on a smartphone as developed by the Cambridge team ( Pr R Hovorka)
Device: automated closed loop glucose control
FreeStyle Navigator II® Continuous Glucose Monitoring (CGM) System (Abbott Diabetes Care, Alameda, CA, USA), DANA Diabecare R subcutaneous insulin pump (SOOIL Development co, Seoul, Korea) and a MPC-based glucose control algorithm running on a smartphone as developed by the Cambridge team ( Pr R Hovorka)
No Intervention: Continuous subcutaneous insulin infusion
Usual pump treatment

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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   12 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03300934


Contacts
Contact: Ulrike de schierloh, MD +35244113173 schierloh.ulrike@chl.lu
Contact: Muriel Fichelle, nurse +35244113173 Fichelle.muriel@chl.lu

Locations
Luxembourg
Clinique des Enfants CHluxembourg Recruiting
Luxembourg, Luxembourg, 1210
Contact: Ulrike Schierloh, MD    +3524411 ext 3173    schierloh.ulrike@chl.lu   
Contact: Muriel Fichelle, nurse    +3524411 ext 3173    Fichelle.muriel@chl.lu   
Sponsors and Collaborators
Centre Hospitalier du Luxembourg
University of Cambridge
Luxembourg Institute of Health
Investigators
Principal Investigator: Carine de Beaufort, MD PhD Centre Hospitalier du Luxembourg
  More Information

Responsible Party: Carine de Beaufort, MD , PhD, Centre Hospitalier du Luxembourg
ClinicalTrials.gov Identifier: NCT03300934     History of Changes
Other Study ID Numbers: Spidiman
First Submitted: September 29, 2017
First Posted: October 4, 2017
Last Update Posted: October 4, 2017
Last Verified: September 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases
Insulin
Hypoglycemic Agents
Physiological Effects of Drugs