ESPEYB16 10. Type 1 Diabetes Mellitus (1) (20 abstracts)
10.3. Psychosocial benefits of insulin pump therapy in children with diabetes type 1 and their families: The pumpkin multicenter randomized controlled trial
Mueller-Godeffroy E , Vonthein R , Ludwig-Seibold C , Heidtmann B , Boettcher C , Kramer M , Hessler N , Hilgard D , Lilienthal E , Ziegler A , Wagner VM & Wagner German Working Group for Pediatric Pump Therapy (agip)
Department of Pediatric and Adolescent Medicine, University of Luebeck, Luebeck, Germany
To read the full abstract: Pediatr Diabetes. 2018;19:1471–1480
It has been debated whether or not new technologies, in particular the combination of insulin pumps and continuous glucose testing, will improve patient satisfaction and quality of life rather than only metabolic control and risk of microvascular complications. Indeed, the use of continuous subcutaneous insulin infusion (CSII) has been increasing among pediatric patients with type 1 diabetes (T1D), particularly in high income countries. Metabolic benefits cannot alone explain this increasing popularity. Therefore, it has been hypothesized that the main benefits of CSII from the patient’s perspective may be related to subjective psychosocial outcomes (patient-reported outcomes [PRO]).
In this multicenter open randomized controlled trial, patients with T1D aged 6–16 years and treated with multiple daily injections (MDI) were randomized either to CSII starting immediately or 6 months later after continuing on multiple daily injections. The primary outcomes were patient-reported diabetes-specific health-related quality of life (DHRQOL) and diabetes burden of the main caregiver (parents or grandparents). Secondary outcomes were family stress, fear of hypoglycemia, and overall satisfaction with treatment. HbA1c levels were assessed additionally.
211 patients were randomized over 4 years, and eventually data from 186 caregivers and 170 patients were included in the intention-to-treat analyses. Children aged 8–11 years in the immediate CSII group reported improved DHRQOL at follow-up compared to MDI (median difference [MD] 9.5, 95% CI: 3.6–16.7, P=0.004). However, there were no group differences in the adolescent age-group 12–16 years (MD 2.7; 95% CI −3.2–9.5; P=0.35). Main caregivers of the CSII group reported a small decline in overall diabetes burden at follow-up compared to the MDI group (MD 0; 95% CI −1–0; P=0.029). Secondary PROs were in favor of CSII.
The authors favour the use of insulin pumps and concluded that CSII can offer substantial psychosocial benefits. However, the data should be seen with great caution since patient satisfaction is related to age, and psychosocial factors are very likely to influence quality of life and also the impact of new technologies on quality of life in a direct way.
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ESPE Yearbook of Paediatric Endocrinology
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