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

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

Study Overview

• Status: Completed
• Conditions: Type1 Diabetes Mellitus
• Intervention / Treatment: Device: closed loop glucose control system

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 Type: Interventional
• Enrollment (Actual): 16
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Luxembourg
  • Luxembourg, Luxembourg, 1210
    • Clinique des Enfants CHluxembourg

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 12 years to 18 years (ADULT, CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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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Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: CROSSOVER
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: closed loop glucose control system; Closed loop glucose control system	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
NO_INTERVENTION: CSII Pump treatment; CSII Pump treatment without the integrated algorithm and glucose sensor

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

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

Collaborators and Investigators

• Sponsor: Centre Hospitalier du Luxembourg
• Collaborators: University of Cambridge; Luxembourg Institute of Health
• Investigators: Principal Investigator: Carine de Beaufort, MD PhD, Centre Hospitalier du Luxembourg

Study record dates

Study Major Dates

• Study Start (ACTUAL): July 1, 2017
• Primary Completion (ACTUAL): July 19, 2018
• Study Completion (ACTUAL): July 19, 2018

Study Registration Dates

• First Submitted: September 29, 2017
• First Submitted That Met QC Criteria: September 29, 2017
• First Posted (ACTUAL): October 4, 2017

Study Record Updates

• Last Update Posted (ACTUAL): July 31, 2018
• Last Update Submitted That Met QC Criteria: July 29, 2018
• Last Verified: July 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Immune System Diseases; Autoimmune Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 1
• Other Study ID Numbers: Spidiman

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No