An interventional study of CONEXIÓN ADAPTAR - DM1 and Usual Care in Type 1 Diabetes Mellitus (T1DM), Parent and Adolescent, sponsored by Universidad de la Sabana. Completed at 2 sites in Colombia. Per ClinicalTrials.gov, last updated 2026-10-21.
Sponsored by Universidad de la Sabana · Not applicable, Interventional, and Supportive care
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.
3,614 studies on the registry are indexed under Diabetes Mellitus, Type 1; 586 are open to participants now.
This study's enrollment of 34 is below the median of 40 across 2,718 interventional studies indexed under Diabetes Mellitus, Type 1.
Browse Diabetes Mellitus, Type 1 studies →Universidad de la Sabana is the lead sponsor of 23 studies on the registry; 8 are open to participants now.
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Exclusion Criteria:
Comprehensive nursing intervention consisting of 8 sessions delivered over 8 weeks.
Behavioral: CONEXIÓN ADAPTAR - DM1
Standard care consisting of quarterly check-ups with specialists, an annual multidisciplinary assessment, and a 24-hour annual educational program (excluding initial education at diagnosis).
Other: Usual Care
Intervention CONEXIÓN ADAPTAR - DM1, consists of 8 sessions for adolescents and parents, the intervention is delivered in person and virtually and seeks to promote adaptation to type 1 Diabetes.
Usual care
Adolescent Glycated Hemoglobin (HbA1c)
Level of glycated hemoglobin (HbA1c) measured in percentage (%) to evaluate glycemic control in adolescents.
Time frame: Three months after baseline assessment.
Adolescent Self-Concept Score
Self-concept score measured using the Visual Analog Scale 4 (EVA-4). Scores range from 0 to 10, where higher scores represent a better self-concept.
Time frame: Baseline, 3 months post-baseline.
Adolescent Health Self-Management
Health self-management measured using the Flinders Living with Diabetes scale. Total scores range from 0 to 84, where higher scores indicate greater self-management ability.
Time frame: Baseline, 3 months post-baseline.
Parental Sleep Quality Score
Sleep quality measured using the Pittsburgh Sleep Quality Index (PSQI). Total scores range from 0 to 21, where lower scores indicate better sleep quality.
Time frame: Baseline, 3 months post-baseline.
Parental Stress Score Assessed by the Parenting Stress Index-Short Form
Parental stress measured using the Parenting Stress Index-Short Form (PSI/SF). Total scores range from 36 to 180, where lower scores represent lower parental stress.
Time frame: 3 months after baseline
Plan to share: No
No publications or documents are linked to this record.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is completed, as verified in May 2026. You cannot join it, but the record below documents what was studied.
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Universidad de la Sabana