NCT07886307Completed
Comprehensive Intervention to Promote Adjustment in Adolescents With Type 1 Diabetes and Their Parents During Transfer of Health Care Responsibility
Comprehensive Intervention to Promote Adjustment in Adolescents With Type 1 Diabetes Mellitus and Their Parents During Transfer of Health Care Responsibility: Feasibility, Acceptability, and Preliminary Efficacy.
Source: ClinicalTrials.gov · Last updated 21 Oct 2026
Brief summary (registry, in English)
Introduction: Type 1 diabetes mellitus is a health condition that produces physical and psychosocial alterations in both the person the person with diabetes mellitus and his or her family, that is why interventions should be designed that make a comprehensive approach to the physiological and psychological aspects of adolescents and parents in order to achieve adaptation to a new normality in the framework of this health condition. Objective: To establish the preliminary efficacy of a comprehensive intervention to promote adaptation in adolescents with type 1 diabetes mellitus and their parents during the transfer of health care responsibility in Bogota, Colombia 2023-2025. Materials and methods: we propose to conduct a pilot study that will develop and evaluate a comprehensive intervention to promote adaptation in adolescents with DM1 and their parents. In the qualitative phase, the needs of adolescents with type 1 diabetes mellitus and their parents will be explored through focus groups. In the quantitative phase, the intervention will be designed and its feasibility, acceptability and preliminary efficacy will be evaluated. A content analysis will be performed on the qualitative data and descriptive and inferential statistical tools will be used for the quantitative data, considering the behavior of the data. Expected results: It is expected to evaluate the preliminary efficacy of a comprehensive intervention to promote adaptation in adolescents with diabetes.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 34 (actual)
- First submitted
- 16 May 2026
- Start date
- Mar 2025
- Primary completion date
- Sept 2025
- Lead sponsor
- Universidad de la Sabana
- Diseases
- Type 1 diabetes
- NCT number
- NCT07886307
What you commit to
- Study type: Interventional
- Participants enrolled: 34
- From Mar 2025 to the primary completion date, Sept 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Parents and adolescents with a diagnosis of cognitive disease that prevents them from participating in the study.
Other
- Adolescents with other endocrine pathologies.
- Adolescents and parents participating in an intervention other than institutional management
Who the study is looking for
- -Adolescents aged 12 to 16 years with a diagnosis of DM1.
- Adolescents diagnosed with DM1 for at least 12 months prior to study enrollment
- Parents of adolescents aged 12 to 16 years with DM1
Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Universidad de La Sabana Coordinator of this site? Confirm its status | Chía | Colombia | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.