Among young patients with type 1 diabetes, insulin pump therapy, compared with insulin injection therapy, was associated with lower risks of severe hypoglycemia and diabetic ketoacidosis and with better glycemic control during the most recent year of therapy. These findings provide evidence for improved clinical outcomes associated with insulin pump therapy compared with injection therapy in children, adolescents, and young adults with type 1 diabetes.
Using a trajectory approach, we determined five distinct longitudinal patterns of glycemic control from childhood to early adulthood. Diabetes self-care, treatment differences, and demographics were related to different HbA courses.
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 http://clinicaltrials.gov
Our study suggests that poor sleep quality is associated with increased HbA1c in adolescents with type 1 diabetes and that higher levels of circadian misalignment are associated with increased insulin requirements. If replicated, our results indicate a clinical relevance of sleep habits in adolescents with type 1 diabetes.
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