Development of a Personalized Growth Hormone Treatment Profile (PGTP) Report for Pediatric Endocrinology

Launched by LUIS FERNANDEZ LUQUE · Feb 14, 2025

Keywords

ClinConnect Summary

This clinical trial, called the Development of a Personalized Growth Hormone Treatment Profile (PGTP) Report for Pediatric Endocrinology, aims to improve growth hormone treatment for children with Growth Hormone Deficiency (GHD). The study will involve 40 families whose children are currently receiving growth hormone therapy. It will explore how tracking treatment usage and gathering feedback from families can help doctors create more personalized treatment plans that better meet each child’s needs. Participants will use a special connected injector device that monitors how often the treatment is taken, and they will also complete surveys to share their experiences.

To be eligible for this study, children must be diagnosed with growth hormone deficiency and be under 18 years old. They should either be starting treatment or already receiving it. Families should be willing to use the connected injector device and provide regular feedback about their child's treatment. It’s important to note that families participating in other studies or those with significant medical conditions that could affect the treatment are not eligible. Through this study, families can help shape the future of growth hormone therapy by providing valuable insights that can lead to better care for their children.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Pediatric patients (up to 18 years old) diagnosed with growth hormone deficiency or disorders requiring growth hormone treatment.
• • Patients are currently undergoing growth hormone therapy. Includes both naive patients (those newly starting weekly treatment) and those already on treatment.
• • Families willing to use connected injector devices and participate in mobile-based psychometrics for the study duration.
• • Families are able and willing to regularly provide patient-reported outcomes (PROs) and adherence data through the Adhera®️ Caring Digital Program.
• • Participants willing to sign the informed consent form, confirming their understanding of the essential aspects of the study, including the potential risks, benefits and rights as participants.
• Exclusion Criteria:
• • Families/patients already enrolled in other study protocols, including the use of connected injector devices and participation in mobile-based psychometrics.
• • Patients with other significant medical conditions that could interfere with growth hormone treatment or the study's data collection processes.
• • Inability to understand or communicate in the language used for data collection and study participation, unless appropriate translation services are available and can be consistently utilized.