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Adherence in children with growth hormone deficiency treated with r-hGH and the easypod™ device
S Loche1, M Salerno2, P Garofalo3
1SSD of Pediatric Endocrinology, Pediatric Hospital Microcitemico Antonio Cao AOB Cagliari, Via Edward Jenner, 09121, Cagliari, Italy. Sandro.loche@aob.it.
Insights
The easypod device improved adherence to recombinant human growth hormone (r-hGH) therapy in children with growth hormone deficiency (GHD). This electronic injector helps physicians monitor treatment compliance and effectiveness.
Area of Science:
- Pediatric Endocrinology
- Pharmacology
- Medical Device Technology
Background:
- Poor adherence to recombinant human growth hormone (r-hGH) therapy is a significant factor in reduced growth velocity in children diagnosed with growth hormone deficiency (GHD).
- Effective monitoring of patient adherence is crucial for optimizing treatment outcomes in pediatric GHD management.
Purpose of the Study:
- To evaluate the adherence rates of pediatric patients with GHD undergoing r-hGH therapy using the easypod™.
- To assess the efficacy of the easypod™, an automated electronic injection device, in tracking treatment adherence over a twelve-month period.
Main Methods:
- A twelve-month observational study involving 97 prepubertal patients with GHD receiving r-hGH therapy across ten Italian clinical sites.
- Adherence was determined by analyzing data recorded by the easypod™ device, focusing on the proportion of correctly administered injections.
- Secondary endpoints included monitoring serum IGF-1 levels, fasting glucose and insulin, and anthropometric measurements (height, waist circumference, BMI).
Main Results:
- The study found that 56.7% of patients achieved full adherence (≥92%) to their r-hGH treatment throughout the twelve-month study period, as indicated by easypod™ data.
- Treatment with r-hGH demonstrated significant improvements in patient stature and a notable increase in serum IGF-1 levels.
- A non-significant trend towards increased fasting blood glucose and insulin levels was observed.
Conclusions:
- The easypod™ injection-recording system provides valuable data for physicians to monitor patient adherence to r-hGH therapy.
- The electronic tracking capabilities of the easypod™ can potentially enhance clinical management and improve treatment outcomes for children with GHD.
Purpose:
Poor adherence to recombinant human growth hormone (r-hGH) therapy is associated with reduced growth velocity in children with growth hormone deficiency (GHD). This twelve-month observational study was to assess adherence in r-hGH patients treated with the easypod™, an electronic, fully automated injection device designed to track the time, date and dose administered.
Methods:
Ninety-seven prepubertal patients receiving r-hGH therapy were included in the study from ten Italian clinical sites and 88 completed the study. To avoid possible confounding effects, only GHD patients (79/88; 89.7 % of the overall study population) were considered in the final analysis. The primary endpoint-adherence to treatment-was calculated as the proportion of injections correctly administered during the observational period out of the expected total number of injections. The relevant information, tracked by the easypod™, was collected at months 6 (V1) and 12 (V2) after baseline (V0). At study termination, adherence data were partially available from 16 patients and fully available from 53 patients. As secondary endpoints, serum IGF-1 levels, fasting serum glucose and insulin levels and key anthropometric characteristics (height, waist circumference and BMI) were also determined.
Results:
The easypod™ data showed that 56.7 % of the patients were considered to be fully (≥92 %) adherent to their treatment throughout the period V0-V2. Treatment improved stature, significantly increased IGF-1 and produced a non-significant increase in blood glucose and insulin levels.
Conclusions:
The injection-recording system and other characteristics of easypod™ could enhance the ability of physicians to monitor adherence to r-hGH treatment.
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