This study is to compare metabolic control, treatment satisfaction, and quality of life during continuous subcutaneous insulin infusion (CSII ) therapy with a new insulin pump system with multiple daily injections (MDI) therapy. Furthermore, this study will add clinical data originating from clinical investigation in a special population, i.e. children and adolescents of ages 2 - 17 years , to the existing clinical data of the ACCU-CHEK Insight insulin pump.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Enrollment
43
Continuous subcutaneous insulin infusion pump
Medical University Graz
Graz, Austria
Universitatsklinik fur PadiatrieI, Padiatrische Diabetologie und Endokrinologie
Innsbruck, Austria
Medical University of Vienna-Dept of Pediatrics
Vienna, Austria
Kinderkrankenhaus auf der Bult
Percentage of Children and Adolescents of Ages 2 to 17 Years Reaching an HbA1c target of <7.5%
This HbA1c target of \<7.5% proportion is statistically tested against a proportion of 25%, composed of the anticipated population proportion of 15% of children and adolescents using multiple daily insulin injections plus a safety margin of 10%.
Time frame: 26 weeks
Score on Insulin Pump Questionnaire
Time frame: 26 weeks
Score on Diabetes Treatment Satisfaction Questionnaire (DTSQ)
Time frame: 26 weeks
Score on Pediatric Quality of Life Inventory (PedsQL)
Time frame: 26 weeks
Change from Baseline in HbA1c
Time frame: 26 weeks
Change from Baseline in Blood Glucose
Time frame: 26 weeks
Number of Subjects, Who Report a Diabetes-Related Adverse Event (i.e., Symptomatic Hypoglycemia, Severe Hypoglycemia, Diabetic Ketoacidosis)
Time frame: 26 weeks
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Hanover, Germany
Gemeinschaftspraxis für Kinder- und Jugendmedizin
Herford, Germany
Practice for Pediatric and Adolescent Diabetology
Münster, Germany
Universitatsklinikum Tubingen
Tübingen, Germany
Birmingham Children's Hospital Foundation Trust
Birmingham, United Kingdom
St. James's University Hospital
Leeds, United Kingdom