Treatment Burden of Weekly Somatrogon vs Daily Somatropin in Children With Growth Hormone Deficiency: A Randomized Study

Context: Somatrogon is a long-acting recombinant human growth hormone treatment developed as a once-weekly treatment for pediatric patients with growth hormone deficiency (GHD). / Objective: Evaluate patient and caregiver perceptions of the treatment burden associated with the once-weekly somatrogon injection regimen vs a once-daily Somatropin injection regimen. / Methods: Pediatric patients (≥3 to <18 years) with GHD receiving once-daily somatropin at enrollment were randomized 1:1 to Sequence 1 (12 weeks of once-daily Somatropin, then 12 weeks of once-weekly somatrogon) or Sequence 2 (12 weeks of once-weekly somatrogon, then 12 weeks of once-daily Somatropin). Treatment burden was assessed using validated questionnaires completed by patients and caregivers. The primary endpoint was the difference in mean overall life interference (LI) total scores after each 12-week treatment period (somatrogon vs Somatropin), as assessed by questionnaires. / Results: Of 87 patients randomized to Sequence 1 (n = 43) or 2 (n = 44), 85 completed the study. Once-weekly somatrogon had a significantly lower treatment burden than once-daily Somatropin, based on mean overall LI total scores after somatrogon (8.63) vs Somatropin (24.13) treatment (mean difference -15.49; 2-sided 95% CI -19.71, -11.27; P < .0001). Once-weekly somatrogon was associated with greater convenience, higher satisfaction with treatment experience, and less LI. The incidence of treatment-emergent adverse events (TEAEs) for Somatropin and somatrogon was 44.2% and 54.0%, respectively. No severe or serious AEs were reported. / Conclusion: In pediatric patients with GHD, once-weekly somatrogon had a lower treatment burden and was associated with a more favorable treatment experience than once-daily Somatropin

Missed insulin meal boluses and elevated hemoglobin A1c levels in children receiving insulin pump therapy.

OBJECTIVE: To identify possible causes of suboptimal glycemic control (ascertained by hemoglobin A1c [HbA1c] level) in youths using insulin pump therapy. METHODS: Forty-eight youths who were receiving insulin pump therapy for \u3e or =6 months, and who were using insulin pumps and blood glucose meters with data that could be downloaded at our facility, are included in this cross-sectional study. Possible causes of suboptimal glycemic control were evaluated by using 4 information sources: 1) insulin pump data downloads; 2) glucose meter data downloads; 3) patient/family questionnaire about insulin bolusing habits, eating habits, exercise, and blood glucose testing habits; and 4) a physician questionnaire. Physicians completed the questionnaire during the patient interview after reviewing the downloaded information and discussing these results with the patient/family. RESULTS: The mean (+/- standard deviation) age of participants was 15.3 (+/-3.0) years (range: 7-20 years), and the mean (+/- standard deviation) duration of type 1 diabetes and continuous subcutaneous insulin infusion was 8.2 (+/-4.0) and 1.9 (+/-1.0) years, respectively. Patients who missed(95% confidence interval) HbA1c level of 8.0% (7.7, 8.3), whereas those who missed \u3e or =1 mealtime boluses per week had a mean HbA1c level (95% confidence interval) of 8.8% (8.6, 9.1). No significant relationships were found between HbA1c levels in males and females, the amount of exercise per week, or bolusing before insulin pump disconnection for exercise. Although not significant, a trend was found for those who missed(r =.414) and mean blood glucose levels (r =.70). CONCLUSION: Missed mealtime insulin boluses seem to be the major cause of suboptimal glycemic control in youths with diabetes receiving continuous subcutaneous insulin infusion therapy

Plain language summary for the manuscript: Understanding the burden of weekly somatrogon injections compared with daily somatropin injections in children with growth hormone deficiency

This is a plain language summary (PLS) of an article published in a peer-reviewed scientific journal. This PLS is not peer-reviewed. The publisher of the original manuscript was not involved in the preparation of this PLS and has neither reviewed nor approved its content.</p