This is a Swedish, Multicentre, Observational Registry to study Adherence and Long Term Outcomes of Therapy in paediatric subjects using Easypod™ electromechanical device for growth hormone treatment to assess the level of adherence of subject receiving SAIZEN® via Easypod™.
Subjects will be enrolled in a multicenter longitudinal observational registry. Parents/subjects will provide their Informed Consent/assent to upload their data for population-based analyses and optionally to adhere to a patient adherence support program designed to improve their adherence and, ultimately, clinical outcomes. Adherence data will be primarily derived from the Easypod™ device combined with physician data entry of outcome measures. Data will be collected retrospectively and prospectively. This will allow the establishment of adherence profiles and explore the hypothesis that patient adherence support programs improve adherence and subsequent clinical outcomes. Collected data will be also analyzed in a multinational pooled analysis of comparable national studies. Primary Objective: • To assess the level of adherence of subjects receiving SAIZEN® via Easypod™ Secondary Objectives: * To describe the impact of adherence on clinical outcomes for subject receiving SAIZEN® via Easypod™ * To identify adherence subject profiling based on age, gender, self injection or not, time on treatment, medical history at time of enrollment * To assess the impact of adherence on Insulin-like Growth Factor 1 (IGF1) (i.e. above, below or within normal ranges) Other Objectives: • To assess the impact of adherence on average blood glucose (HbA1C)
Study Type
OBSERVATIONAL
Enrollment
152
Saizen (Somatotropin) as per Summary of Product Characteristics administered by easypod™
Merck Serono Research Site
Gothenburg, Sweden
Merck Serono Research Site
Solna, Sweden
Merck Serono Research Site
Uppsala, Sweden
Mean percent of daily recorded adherence
Time frame: At least 6 months and up to 5 years
Correlation of adherence and growth outcome (change in height velocity (HV), height velocity-standard deviation score (HV-SDS), height, height-standard deviation score(height SDS) after each year of SAIZEN® treatment with Easypod™
Time frame: At least 6 months and up to 5 years
Subject adherence profile based on age, gender, indication, self-injection or not, time on treatment
Time frame: At least 6 months and up to 5 years
Correlation of adherence with current IGF-1 status (i.e. above, below or within normal ranges)
Time frame: At least 6 months and up to 5 years
Correlation of adherence and HbA1C
Time frame: At least 6 months and up to 5 years
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