Digital Self-Management Education and Support for Young Adults With Type 2 Diabetes (DSMESYAT2DM)
NCT ID: NCT07325838
Last Updated: 2026-01-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
NOT_YET_RECRUITING
NA
72 participants
INTERVENTIONAL
2026-06-16
2027-12-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Young adults with T2DM often have difficulty maintaining good glycemic control and following self-management recommendations. Digital tools and remote education may help support their daily self-care, but there is limited evidence for structured, nurse-led digital programs in this age group.
In this study, 72 young adults aged 18 to 45 years with T2DM will be recruited from the Endocrinology and Metabolism outpatient clinic of Van Regional Training and Research Hospital. Participants who meet the inclusion criteria and provide informed consent will be randomly assigned to either the intervention group or the active control group (36 participants in each group). Randomization will be stratified by baseline HbA1c level.
The intervention group will receive a 12-week nurse-led Digital Diabetes Self-Management Education and Support (DSMES) program delivered via a digital platform. The program will be based on the ADCES7™ self-care behaviors and will include structured educational modules, self-monitoring and goal-setting tools, reminders, motivational messages, and interactive communication with a diabetes nurse and, when needed, other members of the multidisciplinary team.
The active control group will receive usual diabetes care and access to standard digital written education materials (for example, the Ministry of Health Type 2 Diabetes Mellitus patient education brochure in PDF format) via the same platform, as well as basic data entry tools for tracking glucose and related information. However, they will not receive the structured nurse-led DSMES intervention.
Primary outcomes will include changes in diabetes self-management behaviors and glycemic control (for example, HbA1c) from baseline to the end of the 12-week intervention. Secondary outcomes will include changes in diabetes-related distress and user satisfaction and usability of the digital program. Data will be collected using validated questionnaires and clinical laboratory results obtained from the hospital records.
The findings of this study may provide evidence on the effectiveness of a nurse-led digital DSMES program in improving self-management, glycemic control, and distress among young adults with T2DM and may support the integration of digital education and support into routine diabetes care.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Effectiveness of Diabetes Self-management Education on Glycaemic Control in Patients With T2DM
NCT07149311
Game-Based Education and Treatment Adherence in Type 2 Diabetes
NCT07195188
Empowerment Training on Type 2 Diabetes Patients on Empowerment Levels and Clinical Findings
NCT05680207
Digital Diabetes Self Management Education and Support for Patients With Type 2 Diabetes
NCT05026528
Effect of Narrative Education on Glycemic Control in Adults With Type 2 Diabetes in Primary Care
NCT07307430
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
This study is a single-center, parallel-group, randomized controlled trial designed to evaluate the effectiveness of a nurse-led digital DSMES program on self-management behaviors, glycemic control, and diabetes-related distress in young adults with T2DM. The study will be conducted in the Endocrinology and Metabolism outpatient clinic of Van Regional Training and Research Hospital.
A total of 72 participants aged 18 to 45 years with a diagnosis of T2DM will be included. Eligible patients will be literate, have access to the internet and a digital device (such as a smartphone, tablet, or computer), and will not have communication barriers or major physical or mental conditions that prevent participation. Patients with Type 1 diabetes, gestational diabetes, or advanced visual impairment (for example, severe diabetic retinopathy with significant vision loss) will be excluded. After obtaining informed consent, participants will be stratified by baseline HbA1c level (for example, 6.5-9% and \>9%) and then randomly assigned to either the intervention group or the active control group in a 1:1 ratio (36 participants per group). The randomization will be computer-based and performed by a researcher who is not involved in outcome assessment.
The intervention group will receive a 12-week nurse-led digital DSMES program delivered through a web-based and/or mobile digital platform. The content of the program will be structured according to the ADCES7™ self-care behaviors (healthy eating, being active, taking medication, monitoring, reducing risks, healthy coping, and problem solving). The program will include:
digital educational modules presented in text, visual, and/or video formats, tools for self-monitoring of blood glucose and other relevant parameters, individualized goal-setting and progress-tracking features, reminders and motivational messages, interactive communication with a diabetes nurse via messaging or other digital communication functions, and referral or consultation with other members of the multidisciplinary team (such as a dietitian or physician) when necessary.
The nurse will follow a structured protocol for providing education, answering questions, reinforcing self-management behaviors, and supporting problem solving and coping during the 12-week intervention period.
The active control group will receive usual diabetes care provided by the clinic and access to standard digital written diabetes education materials through the same platform. This may include nationally approved patient education brochures for T2DM (for example, the Ministry of Health Type 2 Diabetes Mellitus patient education brochure in PDF format). Control group participants will also be able to enter and view their basic self-monitoring data (such as blood glucose values), but they will not receive the structured, nurse-led DSMES intervention, interactive counseling, or tailored motivational support.
Outcome assessments will be conducted at baseline and at the end of the 12-week intervention period. Primary outcomes will include changes in diabetes self-management behaviors and glycemic control, assessed using a validated Type 2 diabetes self-management scale and laboratory measures such as HbA1c and blood glucose values obtained from hospital records. Secondary outcomes will include changes in diabetes-related distress, measured with a validated diabetes distress scale, and user experience with the digital program, assessed with a mobile or digital application usability scale. Sociodemographic and clinical data will also be collected using standardized forms.
The study is planned as a single-blind design, in which participants are not informed of the specific group allocation (intervention versus active control), although they may recognize differences in the intensity of the digital support they receive. Data analysis will follow the principles of randomized controlled trials, and appropriate statistical methods will be used to compare changes in outcomes between groups, controlling for baseline values.
The findings of this study are expected to contribute to the evidence base on digital, nurse-led DSMES interventions for young adults with T2DM. If effective, the program may inform future integration of structured digital education and support into routine diabetes care and may help improve clinical and psychosocial outcomes in this vulnerable age group.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Nurse-Led Digital DSMES Program
A 12-week nurse-led digital Diabetes Self-Management Education and Support (DSMES) program delivered via a digital platform. The program is structured according to the ADCES7™ self-care behaviors and includes educational modules, self-monitoring and goal-setting tools, reminders, motivational messages, and interactive communication with a diabetes nurse and, when needed, other members of the multidisciplinary team.
Digital Nurse-Led DSMES Program
A 12-week nurse-led digital Diabetes Self-Management Education and Support (DSMES) intervention delivered via a web-based and/or mobile platform. The intervention includes structured educational content based on ADCES7™ self-care behaviors, digital tools for self-monitoring and goal setting, automated reminders, motivational messages, and two-way communication with a diabetes nurse, with referral to other team members (e.g., dietitian, physician) when needed.
Usual Care Plus Standard Digital Education
Participants will receive usual diabetes care provided in the endocrinology clinic together with access to standard digital written diabetes education materials (for example, a nationally approved Type 2 Diabetes Mellitus patient education brochure in PDF format) via the same digital platform. Participants will be able to enter and view basic self-monitoring data but will not receive the structured nurse-led DSMES intervention or interactive counseling.
Usual Care Plus Standard Digital Education
Usual diabetes care provided at the endocrinology clinic along with access to standard digital written Type 2 Diabetes Mellitus patient education materials (e.g., a nationally approved T2DM patient education brochure in PDF format) on the digital platform. Participants can enter and view basic self-monitoring data but do not receive the structured nurse-led DSMES or individualized digital counseling.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Digital Nurse-Led DSMES Program
A 12-week nurse-led digital Diabetes Self-Management Education and Support (DSMES) intervention delivered via a web-based and/or mobile platform. The intervention includes structured educational content based on ADCES7™ self-care behaviors, digital tools for self-monitoring and goal setting, automated reminders, motivational messages, and two-way communication with a diabetes nurse, with referral to other team members (e.g., dietitian, physician) when needed.
Usual Care Plus Standard Digital Education
Usual diabetes care provided at the endocrinology clinic along with access to standard digital written Type 2 Diabetes Mellitus patient education materials (e.g., a nationally approved T2DM patient education brochure in PDF format) on the digital platform. Participants can enter and view basic self-monitoring data but do not receive the structured nurse-led DSMES or individualized digital counseling.
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Diagnosis of Type 2 Diabetes Mellitus.
* Able to read and write in the study language.
* Has access to the internet and to a digital device (such as a smartphone, tablet, or computer).
* No communication barriers (e.g., hearing, speech, or severe cognitive impairment that would prevent understanding of the intervention and questionnaires).
* No physical or mental health condition that, in the opinion of the investigators, would prevent participation in the digital intervention and follow-up.
* Willing and able to use a digital platform/application for diabetes self-management education and support.
* Provides informed consent to participate in the study.
Exclusion Criteria
* Advanced diabetic retinopathy or other severe visual impairment that significantly limits the ability to use digital devices or read educational materials.
* Severe psychiatric disorder or cognitive impairment that would interfere with participation in the intervention or completion of study assessments.
* Any condition that the investigators judge to make the person unsuitable for participation (e.g., severe acute illness, terminal condition).
* Unwillingness or inability to use the digital platform or to share necessary clinical data for the purposes of the study.
18 Years
45 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Recep Turan
OTHER_GOV
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Recep Turan
Internal Medicine Nurse, Principal Investigator
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
HİCRAN BEKTAŞ, PROF. DR.
Role: STUDY_CHAIR
Akdeniz University Faculty of Nursing
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Van Regional Training and Research Hospital, Endocrinology and Metabolism Clinic
Van, , Turkey (Türkiye)
Countries
Review the countries where the study has at least one active or historical site.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Provided Documents
Download supplemental materials such as informed consent forms, study protocols, or participant manuals.
Document Type: Study Protocol
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
TBAEK-1079
Identifier Type: OTHER
Identifier Source: secondary_id
DSMES-2025
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.