Type 1 Diabetes Mellitus (T1DM)NCT07886307
Comprehensive Intervention to Promote Adjustment in Adolescents With Type 1 Diabetes and Their Parents During Transfer of Health Care Responsibility
A study testing CONEXIÓN ADAPTAR - DM1 in people with Type 1 Diabetes Mellitus (T1DM) and Parent, run by Universidad de la Sabana at 2 sites in Colombia.
Trial summary
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… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Type 1 Diabetes Mellitus (T1DM), Parent, Adolescent
- What is being tested?
- CONEXIÓN ADAPTAR - DM1
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 2 sitesColombia
- Study dates
- 1 Mar 2025to 31 Dec 2025
- Phase
- Interventional
- 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
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- -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
Who cannot join
- Adolescents with other endocrine pathologies.
- Adolescents and parents participating in an intervention other than institutional management
- Parents and adolescents with a diagnosis of cognitive disease that prevents them from participating in the study.
Trial locations and contacts
2 sites in 1 country.
Colombia2 sites
Universidad de La Sabana
Chía, Cundinamarca, 250001
Universidad de La Sabana
Chía, 250001
About this study
Official title: 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.
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.
- Conditions
- Type 1 Diabetes Mellitus (T1DM), Parent, Adolescent, Nursing
- Being tested
- CONEXIÓN ADAPTAR - DM1, Usual Care
- Medical subject headings
- Diabetes Mellitus, Type 1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CONEXIÓN ADAPTAR - DM1Behavioural
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 CareOther
Usual care
| Study group | Role | What they receive |
|---|---|---|
| Comprehensive Nursing Intervention Group | Experimental | Comprehensive nursing intervention consisting of 8 sessions delivered over 8 weeks. Receives: Behavioral: CONEXIÓN ADAPTAR - DM1 |
| Standard Usual Care | Active comparator | 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). Receives: Other: Usual Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adolescent Glycated Hemoglobin (HbA1c)
Level of glycated hemoglobin (HbA1c) measured in percentage (%) to evaluate glycemic control in adolescents.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 3 months after baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Oct 2026
- Study start1 Mar 2025
- Primary completion30 Sep 2025
- Study completion31 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 1 Diabetes Mellitus (T1DM)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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- A pilot non-randomized Randomized Clinical Trial is proposed. The intervention group is the one that receives the comprehensive intervention and the comparison group is the one that receives the conventional discharge plan (described later).
- Masking
- None (open label)
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidad de la Sabana
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07886307
- Sponsor's protocol ID
- ENFPHD-24-2024
- Status last verified
- May 2026
- First submitted
- 16 May 2026
- Last updated
- 21 Oct 2026
- 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 21 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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.
- ClinicalTrials.gov ID
- NCT07886307
- Acronym / sponsor ID
- ENFPHD-24-2024
- Conditions
- Type 1 Diabetes Mellitus (T1DM), Parent, Adolescent, Nursing
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- Universidad de la SabanaUniversity, hospital or other
- Study start
- 1 Mar 2025 (actual)
- Primary completion
- 30 Sep 2025 (actual)
- Study completion
- 31 Dec 2025 (actual)
- First posted
- 21 Oct 2026 (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.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- A pilot non-randomized Randomized Clinical Trial is proposed. The intervention group is the one that receives the comprehensive intervention and the comparison group is the one that receives the conventional discharge plan (described later).
| Arm | Type | Receives |
|---|---|---|
| Comprehensive Nursing Intervention Group | Experimental | Behavioral: CONEXIÓN ADAPTAR - DM1Comprehensive nursing intervention consisting of 8 sessions delivered over 8 weeks. |
| Standard Usual Care | Active comparator | Other: Usual CareStandard care consisting of quarterly check-ups with specialists, an annual multidisciplinary assessment, and a 24-hour annual educational program (excluding initial education at diagnosis). |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- -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
Key exclusion criteria (3 listed)
- Adolescents with other endocrine pathologies.
- Adolescents and parents participating in an intervention other than institutional management
- Parents and adolescents with a diagnosis of cognitive disease that prevents them from participating in the study.
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 |
|---|---|---|
| CONEXIÓN ADAPTAR - DM1Intervention 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. | Behavioural | Comprehensive Nursing Intervention Group |
| Usual CareUsual care | Other | Standard Usual Care |
Primary outcome
Adolescent Glycated Hemoglobin (HbA1c)
Time frame: Three months after baseline assessment.
Level of glycated hemoglobin (HbA1c) measured in percentage (%) to evaluate glycemic control in adolescents.
Adolescent Self-Concept Score
Time frame: Baseline, 3 months post-baseline.
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.
Adolescent Health Self-Management
Time frame: Baseline, 3 months post-baseline.
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.
Parental Sleep Quality Score
Time frame: Baseline, 3 months post-baseline.
Sleep quality measured using the Pittsburgh Sleep Quality Index (PSQI). Total scores range from 0 to 21, where lower scores indicate better sleep quality.
Parental Stress Score Assessed by the Parenting Stress Index-Short Form
Time frame: 3 months after baseline
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.
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 21 Oct 2026.
- 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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CONEXIÓN ADAPTAR - DM1 in people with Type 1 Diabetes Mellitus (T1DM) and Parent, run by Universidad de la Sabana at 2 sites in Colombia.
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 3 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 21 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Colombia. 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?
Adolescent Glycated Hemoglobin (HbA1c) (time frame: Three months after baseline assessment.). The study lists 5 primary outcomes in all. 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 21 Oct 2026.