1. Psychosocial benefits of insulin pump therapy in children with diabetes type 1 and their families: The pumpkin multicenter randomized controlled trial
- Author
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Eggert Lilienthal, Mario W. Kramer, Claudia Boettcher, C Ludwig-Seibold, Doerte Hilgard, Esther Mueller-Godeffroy, Andreas Ziegler, Bettina Heidtmann, Verena M. Wagner, Reinhard Vonthein, and Nicole Hessler
- Subjects
Male ,Insulin pump ,Pediatrics ,medicine.medical_specialty ,Adolescent ,Endocrinology, Diabetes and Metabolism ,Psychology, Adolescent ,030209 endocrinology & metabolism ,Hypoglycemia ,law.invention ,03 medical and health sciences ,0302 clinical medicine ,Insulin Infusion Systems ,Cost of Illness ,Quality of life ,Randomized controlled trial ,law ,Germany ,Diabetes mellitus ,Internal Medicine ,medicine ,Humans ,Insulin ,Family ,030212 general & internal medicine ,Patient Reported Outcome Measures ,Child ,Type 1 diabetes ,business.industry ,medicine.disease ,Diabetes Mellitus, Type 1 ,Treatment Outcome ,Patient Satisfaction ,Pediatrics, Perinatology and Child Health ,Quality of Life ,Caregiver stress ,Female ,business ,Psychosocial - Abstract
Objective Continuous subcutaneous insulin infusion (CSII) is on the rise among pediatric patients with type 1 diabetes mellitus. Metabolic effects alone cannot explain this rising popularity. From the patient's perspective, the main benefits of CSII may be found in subjective psychosocial health outcomes (patient-reported outcomes [PRO]). Subjects and methods In a multicenter open randomized controlled trial, children and adolescents aged 6 to16 years currently treated with multiple daily injections (MDI) were randomized 1:1, stratified by center, to either starting with CSII immediately after the baseline interview or to continuing MDI while waiting 6 months for transmission to CSII. The primary outcomes were patient-reported diabetes-specific health-related quality of life (DHRQOL) and diabetes burden of the main caregiver. Secondary outcomes were caregiver stress, fear of hypoglycemia, satisfaction with treatment, and HbA1c. Results Two-hundred and eleven patients were randomized between February 2011 and October 2014, and 186 caregivers and 170 patients were analyzed using the intention-to-treat principle for primary outcomes. Children 8 to 11 years in the CSII group reported improved DHRQOL at follow-up compared to MDI (median difference [MD] 9.5, 95% confidence interval [CI] 3.6-16.7, P = 0.004). There were no treatment differences in the adolescent age-group 12 to 16 years (MD 2.7; 95% CI -3.2-9.5; P = 0.353). The main caregivers of the CSII group reported a significant decline of overall diabetes burden at follow-up compared to the MDI group (MD 0; 95% CI -1-0; P = 0.029). Secondary PROs also were in favor of CSII. Conclusions CSII has substantial psychosocial benefits. PROs demonstrate these benefits. Registered as NCT01338922 at clinicaltrials.gov.
- Published
- 2019
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