Type1 Diabetes Mellitus Clinical Trial
— SPIDIMAN2Official title:
Adolescence and Diabetes: Can an Automated Closed Loop System Improve Control ?
NCT number | NCT03300934 |
Other study ID # | Spidiman |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | July 1, 2017 |
Est. completion date | July 19, 2018 |
Verified date | July 2018 |
Source | Centre Hospitalier du Luxembourg |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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
Status | Completed |
Enrollment | 16 |
Est. completion date | July 19, 2018 |
Est. primary completion date | July 19, 2018 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 12 Years to 18 Years |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
Luxembourg | Clinique des Enfants CHluxembourg | Luxembourg |
Lead Sponsor | Collaborator |
---|---|
Centre Hospitalier du Luxembourg | Luxembourg Institute of Health, University of Cambridge |
Luxembourg,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | 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 | |
Secondary | 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 | |
Secondary | Severe hypoglycaemic events | ISPAD Definition of severe hypoglycemia | 4 week treatment arms | |
Secondary | Severe Diabetes ketoacidosis | ISPAD definition of severe DKA | 4 week treatment arms | |
Secondary | Use of the automated closed loop system (% time) | % time , the system is used | 4 week treatment arm | |
Secondary | Use of the CGM during closed loop | % time , the system is used | 4 week treatment arm | |
Secondary | Quality of life perception in adolescents | Questionnaire based | 4 week treatment periods | |
Secondary | Family Responsibility perception | Questionnaire based : Family responsibility scale | 4 week treatment periods | |
Secondary | User experience after the 4 week treatment | questionnaire based | 4 week intervention |
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