Back to results

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

Primary Purpose

Type1 Diabetes Mellitus

Status

Completed

Phase

Not Applicable

Locations

Luxembourg

Study Type

Interventional

Intervention

closed loop glucose control system

About this trial

This is an interventional treatment trial for Type1 Diabetes Mellitus

Eligibility Criteria

12 Years - 18 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Clinique des Enfants CHluxembourg

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

closed loop glucose control system

CSII Pump treatment

Arm Description

Closed loop glucose control system

CSII Pump treatment without the integrated algorithm and glucose sensor

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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 (%)

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

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

Severe hypoglycaemic events

ISPAD Definition of severe hypoglycemia

Severe Diabetes ketoacidosis

ISPAD definition of severe DKA

Use of the automated closed loop system (% time)

% time , the system is used

Use of the CGM during closed loop

% time , the system is used

Quality of life perception in adolescents

Questionnaire based

Family Responsibility perception

Questionnaire based : Family responsibility scale

User experience after the 4 week treatment

questionnaire based

Full Information

NCT ID

NCT03300934

First Posted

September 29, 2017

Last Updated

July 29, 2018

Sponsor

Centre Hospitalier du Luxembourg

Collaborators

University of Cambridge, Luxembourg Institute of Health

1. Study Identification

Unique Protocol Identification Number

NCT03300934

Brief Title

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

Acronym

SPIDIMAN2

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

July 2018

Overall Recruitment Status

Completed

Study Start Date

July 1, 2017 (Actual)

Primary Completion Date

July 19, 2018 (Actual)

Study Completion Date

July 19, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Centre Hospitalier du Luxembourg

Collaborators

University of Cambridge, Luxembourg Institute of Health

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Type1 Diabetes Mellitus

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Crossover Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

16 (Actual)

8. Arms, Groups, and Interventions

Arm Title

closed loop glucose control system

Arm Type

Experimental

Arm Description

Closed loop glucose control system

Arm Title

CSII Pump treatment

Arm Type

No Intervention

Arm Description

CSII Pump treatment without the integrated algorithm and glucose sensor

Intervention Type

Device

Intervention Name(s)

closed loop glucose control system

Intervention Description

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

Primary Outcome Measure Information:

Title

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

Description

Continuous blinded glucose monitoring during the study period with and without the automated Closed loop on a between arm comparison.

Time Frame

4 week treatment arms

Secondary Outcome Measure Information:

Title

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

Description

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

Time Frame

4 week treatment arms

Title

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

Description

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

Time Frame

4 week treatment arms

Title

Severe hypoglycaemic events

Description

ISPAD Definition of severe hypoglycemia

Time Frame

4 week treatment arms

Title

Severe Diabetes ketoacidosis

Description

ISPAD definition of severe DKA

Time Frame

4 week treatment arms

Title

Use of the automated closed loop system (% time)

Description

% time , the system is used

Time Frame

4 week treatment arm

Title

Use of the CGM during closed loop

Description

% time , the system is used

Time Frame

4 week treatment arm

Title

Quality of life perception in adolescents

Description

Questionnaire based

Time Frame

4 week treatment periods

Title

Family Responsibility perception

Description

Questionnaire based : Family responsibility scale

Time Frame

4 week treatment periods

Title

User experience after the 4 week treatment

Description

questionnaire based

Time Frame

4 week intervention

10. Eligibility

Sex

All

Minimum Age & Unit of Time

12 Years

Maximum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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 -

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Carine de Beaufort, MD PhD

Organizational Affiliation

Centre Hospitalier du Luxembourg

Official's Role

Principal Investigator

Facility Information:

Facility Name

Clinique des Enfants CHluxembourg

City

Luxembourg

ZIP/Postal Code

1210

Country

Luxembourg

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

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

We'll reach out to this number within 24 hrs