Accu-Chek Insight Pump System
DeviceContinuous subcutaneous insulin infusion pump
NCT Number: NCT02403375
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.
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Notify Me2 year–17 year
All sexes
Interventional
Not applicable
Medical University Graz, Graz, Austria
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Continuous subcutaneous insulin infusion pump
Time frame: 26 weeks
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
Time frame: 26 weeks
Time frame: 26 weeks
Time frame: 26 weeks
Time frame: 26 weeks
Time frame: 26 weeks
Hoffmann-La Roche
Industry
Insight Kids Study: Reaching HbA1c Targets in Children and Adolescents With Type 1 Diabetes
Acronym: Insight Kids
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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