Esther Mueller-Godeffroy1, Reinhard Vonthein2,3, Carmen Ludwig-Seibold4, Bettina Heidtmann5, Claudia Boettcher6, Miriam Kramer6, Nicole Hessler2, Doerte Hilgard7,8, Eggert Lilienthal9, Andreas Ziegler2,3,10, Verena M Wagner1,11. 1. Department of Pediatric and Adolescent Medicine, University of Luebeck, Luebeck, Germany. 2. Institute of Medical Biometry and Statistics, University of Luebeck, University Medical Center Schleswig-Holstein, Luebeck, Germany. 3. Center for Clinical Trials, University of Luebeck, Luebeck, Germany. 4. Department of Pediatrics, Oberschwabenklinik GmbH, Wangen, Germany. 5. Catholic Children's Hospital, Wilhelmstift gGmbH, Department of Endocrinology and Diabetology, Hamburg, Germany. 6. Division of Pediatric Endocrinology and Diabeteology, Center of Child and Adolescent Medicine, Justus Liebig University Giessen, Frankfurt, Germany. 7. Department of Pediatrics, Gemeinschaftskrankenhaus Herdecke gGmbH, Herdecke, Germany. 8. Pediatric and Adolescent Medical Practice, Witten, Germany. 9. Department of Pediatrics, St. Josef-Hospital, Ruhr-University Bochum, Bochum, Germany. 10. School of Mathematics, Statistics and Computer Science, University of KwaZulu-Natal, Pietermaritzburg, South Africa. 11. Pediatric and Adolescent Medical Practice, 18055 Rostock, Germany.
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 withmultiple 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.
RCT Entities:
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.
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