Growth Hormone Deficiency (GHD)PGTPNCT06830525
Development of a Personalized Growth Hormone Treatment Profile (PGTP) Report for Pediatric Endocrinology
An observational study of Growth Hormone Deficiency (GHD), run by Luis Fernandez Luque at 1 site in Spain.
Trial summary
The goal of this observational study is to learn how to make growth hormone treatment more personalized for children. The main questions it aims to answer are: How can information about treatment adherence and patient experiences help improve care? What insights can help doctors create treatment plans that are more… Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Growth Hormone Deficiency (GHD)
- What is being tested?
- ACDP® and growth hormone treatment
- How many people
- 40 participants
- Where
- 1 siteSpain
- Study dates
- 19 May 2025to 12 Nov 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: The sample of the study (children and their caregivers) will be recruited from the Pediatric Endocrinology unit at the Miguel Servet Children's University Hospital. This public hospital provides pediatric health attention to the regional area of Zaragoza (Spain), which covers a total of 367.110 inhabitants. Families of children undergoing growth hormone therapy and are willing to join a combined intervention.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
The goal of this observational study is to learn how to make growth hormone treatment more personalized for children. The main questions it aims to answer are:
- How can information about treatment adherence and patient experiences help improve care?
- What insights can help doctors create treatment plans that are more tailored to each child?
The study will include 40 families of children who are using a connected injector device for their growth hormone treatment. These devices track how often the treatment is taken, and families will also share their experiences through surveys. The information will be used to develop a new tool, similar to tools used in diabetes care, to help doctors create better, personalized treatment plans for children with growth hormone needs.
- Conditions
- Growth Hormone Deficiency (GHD)
- Being tested
- ACDP® and growth hormone treatment
- Keywords
- Growth Hormone Disorder, Digital health, pediatric endocrinology, Personalized Growth Hormone Treatment Profile
- Medical subject headings
- Dwarfism, Pituitary
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ACDP® and growth hormone treatmentCombination product
A cohort of 40 families of children undergoing growth hormone treatment using a connected injector devices that quantifies treatment adherence will be recruited via the ACDP®, to capture additional data that combine Patient Reported Outcomes and Adherence Data.
| Study group | Role | What they receive |
|---|---|---|
| Families with children undergoing growth hormone treatment | The study targets families of children with growth hormone deficiency (GHD) under growth hormone treatment, using a connected injector device that quantifies treatment adherence. We will recruit 40 families, divided into two groups: one group with adherence rates of <85%, and the other group with adherence rates of >85%. Receives: Combination Product: ACDP® and growth hormone treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Develop a Personalized Growth Hormone Treatment Profile (PGTP)
To develop a Personalized Growth Hormone Treatment Profile (PGTP) standard - analogous to the Ambulatory Glucose Profile (AGP) for diabetes care-, integrating diverse data sources to support personalized treatment strategies in pediatric endocrinology.
Measured: From enrollment to the end of the study at Month 12
Secondary outcomes (13)
Adherence to Treatment Using Connected Injector Devices
Automated tracking of injection times and adherence. Adherence will be quantified through connected injector device data, capturing timestamps of each injection and calculating adherence rates.
Measured: From enrollment to the end of the study at Month 12
Physiological Monitoring via Wearable Devices - Sleep Quality
Unit of Measure:
- Total sleep duration (hours per night). Description: Sleep parameters will be tracked using wearable devices.
Measured: From enrollment to the end of the study at Month 12
Physiological Monitoring via Wearable Devices - Heart Rate
Unit of Measure: Average daily heart rate (beats per minute, bpm). Description: Daily average heart rate recorded through wearable devices.
Measured: From enrollment to the end of the study at Month 12
Physiological Monitoring via Wearable Devices - Physical Activity Metrics
Unit of Measure:
- Total calories burned per day (kilocalories, kcal).
- Total steps per day (steps).
- Total activity time per day (minutes).
Description: Data will be collected from wearable devices to assess daily physical activity.
Measured: From enrollment to the end of the study at Month 12
Physiological Monitoring via Wearable Devices - Blood Oxygen Levels
Unit of Measure: Daily oxygen saturation percentage (%). Description: Measured through wearable device sensors.
Measured: From enrollment to the end of the study at Month 12
Evaluating Usability of Connected Devices
Outcome Measure: System Usability Scale (SUS) score. Unit of Measure: SUS score (0-100, higher scores indicate better usability). Description: The System Usability Scale (Bangor et al., 2008) is a 10-item scale based on a 5-point Likert scale assessing perceived usability.
Measured: From enrollment to the end of the study at Month 12
Mobile Application Engagement
Outcome Measure: User engagement with the mobile application. Unit of Measure: Frequency of interactions (e.g., number of logins per day/week).
Description: Engagement will be assessed using mobile user logs, including user profiling metrics based on Hors-Fraile et al. (2018).
Measured: From enrollment to the end of the study at Month 12
Distress Assessment 2
Distress Thermometer Unit of Measure: Score on a 0-10 scale (higher scores indicate higher distress).
Description: The Distress Thermometer is a single-item, self-report tool measuring psychological distress on a 0-10 scale.
Measured: From enrollment to the end of the study at Month 12
Distress Assessment 2
Depression, Anxiety, and Stress Scale - 21 Items (DASS-21) Unit of Measure: Score range 0-63 (higher scores indicate greater distress). Description: The DASS-21 is a 21-item scale measuring general affective distress, including depression, anxiety, and stress, over the past week.
Measured: From enrollment to the end of the study at Month 12
Self-Efficacy Assessment
General Self-Efficacy Scale (GSE) Unit of Measure: Score range 10-40 (higher scores indicate greater self-efficacy).
Description: The GSE scale measures an individual's belief in their ability to cope with adversity.
Measured: From enrollment to the end of the study at Month 12
Mood Assessment
Positive and Negative Affect Schedule (PANAS)
Unit of Measure:
- Positive Affect (PA) score range: 10-50 (higher scores indicate greater positive affect).
- Negative Affect (NA) score range: 10-50 (higher scores indicate greater negative affect).
Description: PANAS is a self-report questionnaire measuring two dimensions of mood: positive and negative affect.
Measured: From enrollment to the end of the study at Month 12
Mental Health and Well-Being Assessment
Mental Health Continuum-Short Form (MHC-SF) Unit of Measure: Score range 0-70 (higher scores indicate better mental health).
Description: The MHC-SF is a 14-item scale assessing emotional, social, and psychological well-being as indicators of positive mental health.
Measured: From enrollment to the end of the study at Month 12
Health-Related Quality of Life (HRQoL)
KIDSCREEN-10 Unit of Measure: Score range 10-50 (higher scores indicate better health-related quality of life).
Description: The KIDSCREEN-10 is a health-related quality of life measure for children and adolescents, assessing physical, psychological, and social well-being, autonomy, school environment, and peer and family support.
Measured: From enrollment to the end of the study at Month 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2025
- Study start19 May 2025
- Primary completion12 Nov 2025
- Study completion12 Nov 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Growth Hormone Deficiency (GHD)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Luis Fernandez Luque
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Hospital Miguel Servet
- Responsible party
- Sponsor-investigator, Luis Fernandez Luque, Adhera Health, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06830525
- Sponsor's protocol ID
- PGTP
- Acronym
- PGTP
- Status last verified
- Nov 2025
- First submitted
- 23 Jan 2025
- Last updated
- 1 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development of a Personalized Growth Hormone Treatment Profile (PGTP) Report for Pediatric Endocrinology
- ClinicalTrials.gov ID
- NCT06830525
- Acronym / sponsor ID
- PGTP / PGTP
- Conditions
- Growth Hormone Deficiency (GHD)
- Keywords
- Growth Hormone Disorder, Digital health, pediatric endocrinology, Personalized Growth Hormone Treatment Profile
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Luis Fernandez LuqueIndustry (pharma, biotech, devices)
- Collaborators
- Hospital Miguel Servet
- Study start
- 19 May 2025 (actual)
- Primary completion
- 12 Nov 2025 (actual)
- Study completion
- 12 Nov 2025 (actual)
- First posted
- 17 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this observational study is to learn how to make growth hormone treatment more personalized for children. The main questions it aims to answer are:
- How can information about treatment adherence and patient experiences help improve care?
- What insights can help doctors create treatment plans that are more tailored to each child?
The study will include 40 families of children who are using a connected injector device for their growth hormone treatment. These devices track how often the treatment is taken, and families will also share their experiences through surveys. The information will be used to develop a new tool, similar to tools used in diabetes care, to help doctors create better, personalized treatment plans for children with growth hormone needs.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Families with children undergoing growth hormone treatment | – | Combination Product: ACDP® and growth hormone treatmentThe study targets families of children with growth hormone deficiency (GHD) under growth hormone treatment, using a connected injector device that quantifies treatment adherence. We will recruit 40 families, divided into two groups: one group with adherence rates of <85%, and the other group with adherence rates of >85%. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- The sample of the study (children and their caregivers) will be recruited from the Pediatric Endocrinology unit at the Miguel Servet Children's University Hospital. This public hospital provides pediatric health attention to the regional area of Zaragoza (Spain), which covers a total of 367.110 inhabitants. Families of children undergoing growth hormone therapy and are willing to join a combined intervention.
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ACDP® and growth hormone treatmentA cohort of 40 families of children undergoing growth hormone treatment using a connected injector devices that quantifies treatment adherence will be recruited via the ACDP®, to capture additional data that combine Patient Reported Outcomes and Adherence Data. | Combination product | Families with children undergoing growth hormone treatment |
Primary outcome
Develop a Personalized Growth Hormone Treatment Profile (PGTP)
Time frame: From enrollment to the end of the study at Month 12
To develop a Personalized Growth Hormone Treatment Profile (PGTP) standard - analogous to the Ambulatory Glucose Profile (AGP) for diabetes care-, integrating diverse data sources to support personalized treatment strategies in pediatric endocrinology.
13 secondary outcomes
Adherence to Treatment Using Connected Injector Devices
Time frame: From enrollment to the end of the study at Month 12
Physiological Monitoring via Wearable Devices - Sleep Quality
Time frame: From enrollment to the end of the study at Month 12
Physiological Monitoring via Wearable Devices - Heart Rate
Time frame: From enrollment to the end of the study at Month 12
Physiological Monitoring via Wearable Devices - Physical Activity Metrics
Time frame: From enrollment to the end of the study at Month 12
Physiological Monitoring via Wearable Devices - Blood Oxygen Levels
Time frame: From enrollment to the end of the study at Month 12
Evaluating Usability of Connected Devices
Time frame: From enrollment to the end of the study at Month 12
Mobile Application Engagement
Time frame: From enrollment to the end of the study at Month 12
Distress Assessment 2
Time frame: From enrollment to the end of the study at Month 12
Distress Assessment 2
Time frame: From enrollment to the end of the study at Month 12
Self-Efficacy Assessment
Time frame: From enrollment to the end of the study at Month 12
Mood Assessment
Time frame: From enrollment to the end of the study at Month 12
Mental Health and Well-Being Assessment
Time frame: From enrollment to the end of the study at Month 12
Health-Related Quality of Life (HRQoL)
Time frame: From enrollment to the end of the study at Month 12
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Dec 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Growth Hormone Deficiency (GHD), run by Luis Fernandez Luque at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Develop a Personalized Growth Hormone Treatment Profile (PGTP) (time frame: From enrollment to the end of the study at Month 12). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Dec 2025.