Esther Mueller?Godeffroy|Reinhard Vonthein|C Ludwig-Seibold|Bettina Heidtmann|Claudia Boettcher|M Kramer|Nicole Heßler|Doerte Hilgard|Eggert Lilienthal|Andreas Ziegler|Verena Wagner
Psychosocial benefits of insulin pump therapy in children with diabetes type 1 and their families: The pumpkin multicenter randomized controlled trial
University of Lübeck|University of Lübeck|Landwirtschaftlichen Zentrums Baden-Württemberg?|Katholisches Kinderkrankenhaus Wilhelmstift|University of Giessen|University of Giessen|University of Lübeck|Gemeinschaftskrankenhaus Herdecke|St. Josef-Hospital|Ruhr University Bochum|University of Lübeck|University of KwaZulu-Natal|University of Lübeck|University of Rostock
continuous subcutaneous insulin infusion csii rise among pediatric patients type 1 diabetes mellitus metabolic effects alone cannot explain rising popularity patients perspective main benefits csii may found subjective psychosocial health outcomes patientreported outcomes proin multicenter open randomized controlled trial children adolescents aged 6 to16 years currently treated multiple daily injections mdi randomized 11 stratified center either starting csii immediately baseline interview continuing mdi waiting 6 months transmission csii primary outcomes patientreported diabetesspecific healthrelated quality life dhrqol diabetes burden main caregiver secondary outcomes caregiver stress fear hypoglycemia satisfaction treatment hba1ctwohundred eleven patients randomized february 2011 october 2014 186 caregivers 170 patients analyzed using intentiontotreat principle primary outcomes children 8 11 years csii group reported improved dhrqol followup compared mdi median difference md 95 95 confidence interval ci 36167 p 0004 treatment differences adolescent agegroup 12 16 years md 27 95 ci 3295 p 0353 main caregivers csii group reported significant decline overall diabetes burden followup compared mdi group md 0 95 ci 10 p 0029 secondary pros also favor csiicsii substantial psychosocial benefits pros demonstrate benefits registered nct01338922 clinicaltrialsgov