The Effect of a Digital Self-Management Education and Support Program on Self-Management, Glycemic Control, and Distress in Young Adults With Type 2 Diabetes Mellitus
Phase: NA
Conditions: Type 2 Diabetes Mellitus (T2DM), Diabetes-related Distress, Diabetes Distress
Sponsor: Recep Turan

Official Title: 
The Effect of a Digital Self-Management Education and Support Program on Self-
Management, Glycemic Control, and Distress in Young Adults With Type 2 Diabetes Mellitus 
 
NCT Number: 
Not yet assigned 
 
Document Title: 
Study Protocol 
 
Date of Document: 
03 January 2026 
 
Sponsor / Responsible Party: 
Recep Turan 
Internal Medicine Nurse, Principal Investigator 
 
Affiliation: 
Antalya Training and Research Hospital 
Akdeniz University, Faculty of Nursing 
(Study Chair: Prof. Dr. Hicran Bektaş) 
 
Note: At the time of document preparation and initial submission to ClinicalTrials.gov, an 
NCT number has not yet been assigned to this study. 
 
 

5. Detailed Description 
Detailed Description: 
Type 2 diabetes mellitus (T2DM) is increasingly being diagnosed in young adults, who often 
face unique psychological, social, and lifestyle challenges that can negatively affect diabetes 
self-management, glycemic control, and quality of life. Inadequate self-management 
behaviors, suboptimal glycemic control, and high levels of diabetes-related distress in this 
age group increase the risk of acute complications and early onset of chronic complications. 
Evidence-based diabetes self-management education and support (DSMES) is essential to 
empower individuals with T2DM to manage their condition effectively. However, traditional 
face-to-face education programs may be limited by accessibility, time constraints, and lack 
of continuity, particularly for young adults who are working, studying, or living in different 
locations. 
Digital health interventions, including mobile and web-based platforms, provide an 
opportunity to deliver flexible, interactive, and personalized DSMES. Nurse-led digital 
interventions can combine clinical expertise with ongoing support, thereby enhancing 
engagement, adherence, and behavior change. This study has been designed to evaluate the 
effect of a comprehensive, nurse-led digital DSMES program on self-management, glycemic 
control, and diabetes distress in young adults with T2DM. 
Study Design 
This study is a single-center, parallel-group, randomized controlled trial with an 
intervention group and an active control group. The trial will be conducted at Van Regional 
Training and Research Hospital, Endocrinology and Metabolism Diseases Outpatient Clinic 
(Van, Türkiye). A total of 72 participants diagnosed with T2DM, aged between 18 and 45 
years, who meet the eligibility criteria and provide informed consent, will be included. The 
planned study duration is 24 months, including preparation, recruitment, intervention, 
follow-up, data analysis, and reporting. The intervention period for each participant is 12 
weeks. 
Participants 
Inclusion criteria include: (1) diagnosis of type 2 diabetes mellitus, (2) age 18–45 years, (3) 
ability to communicate in Turkish, (4) literacy, (5) access to the internet and ability to use a 
smartphone, tablet, or computer, (6) no severe physical or mental health condition that 
would prevent participation, and (7) willingness to provide informed consent and 
participate in digital follow-up. 
Exclusion criteria include: (1) presence of advanced diabetic retinopathy with severe visual 
impairment that prevents use of digital tools, (2) diagnosis of type 1 diabetes or gestational 
diabetes, (3) refusal to share necessary information for the study, and (4) participation in 
another structured DSMES program that could interfere with the intervention. 

Withdrawal criteria include: (1) participant request to withdraw at any time, (2) inability to 
complete follow-up assessments, (3) interruption of internet access or digital 
communication for more than two weeks, (4) failure to start the program within four weeks 
after enrollment or participation in less than 50% of the planned intervention, (5) initiation 
of GLP-1 receptor agonist therapy during the study period, and (6) any new health 
condition deemed by the investigator to make continued participation inappropriate. 
Randomization and Blinding 
After baseline assessment, participants will be randomized in a 1:1 ratio to the intervention 
or active control group using stratified block randomization. Stratification will be based on 
baseline HbA1c levels (6.5–9% and > 9%) to ensure balanced glycemic status across groups. 
The randomization list will be generated by an independent researcher. Participants will 
not be explicitly informed of their group allocation (single-blind design); however, due to 
the nature of the intervention, the research team delivering the DSMES program cannot be 
blinded. 
Intervention Group: Nurse-Led Digital DSMES Program 
Participants in the intervention group will receive a 12-week nurse-led digital DSMES 
program delivered through a dedicated digital platform. The program is structured 
according to the ADCES7™ self-care behavior framework (healthy coping, healthy eating, 
being active, monitoring, taking medication, problem solving, and reducing risks). Key 
components of the program include: 
1. Structured Digital Education Modules: Educational content on T2DM pathophysiology, 
treatment, self-monitoring, nutrition, physical activity, medication adherence, complication 
prevention, and psychosocial coping strategies, presented in user-friendly language with 
visual aids. 
2. Interactive Self-Monitoring Tools: Digital forms and tracking cards that allow participants 
to record glycemic values (fasting and postprandial glucose), HbA1c (when available), blood 
pressure (if applicable), and self-care behaviors related to the ADCES7™ domains. 
Participants will receive automated reminders to encourage regular data entry. 
3. Nurse-Led Individualized Counseling and Support: Regularly scheduled synchronous and 
asynchronous communications (such as messaging or calls) with a nurse trained in diabetes 
education. The nurse will review participants’ data, provide tailored feedback, reinforce 
educational messages, support goal-setting and problem solving, and offer motivational 
encouragement. 
4. Digital Support and Chatbot: A chatbot or FAQ component to provide quick answers to 
common questions about diabetes management, medication use, hypoglycemia 
management, and lifestyle behaviors, supplementing nurse support. 

5. Multidisciplinary Collaboration (as needed): When necessary, participants may be guided 
to consult their physician, dietitian, or psychologist for issues identified during the digital 
follow-up. The nurse will facilitate communication and encourage participants to seek 
appropriate in-person or telehealth services. 
Participants in the intervention group will be encouraged to engage with the platform 
regularly, follow the educational modules according to the suggested schedule, record their 
data, and communicate with the nurse as needed. 
Active Control Group: Standard Digital Education 
Participants in the active control group will be provided with access to the standard Type 2 
Diabetes Education Brochure prepared by the Turkish Ministry of Health in PDF format via 
the digital platform. They will also be able to enter their basic glycemic data into the system. 
However, they will not receive individualized nurse-led digital counseling, structured 
DSMES modules based on ADCES7™, or chatbot-based interactive support. This design 
allows comparison of the comprehensive nurse-led digital DSMES program with standard 
digitally delivered education materials. 
Outcome Measures 
Primary and secondary outcomes will be assessed at baseline (pre-intervention) and at the 
end of the 12-week intervention. 
Primary Outcomes: 
1. Self-Management: Assessed using the Type 2 Diabetes Self-Management Scale, which 
evaluates 
key 
aspects 
of 
diabetes 
self-care 
behaviors. 
2. Glycemic Control: Assessed by HbA1c levels obtained from laboratory records. 
Secondary 
Outcomes: 
1. 
Diabetes 
Distress: 
Measured 
using 
the 
Diabetes 
Distress 
Scale. 
2. Additional Glycemic Parameters: Fasting plasma glucose and postprandial plasma glucose 
values. 
3. Self-Management Behaviors: Assessed using the ADCES7™ Self-Management Behaviors 
Assessment Form and the Type 2 Diabetes Personal Behavior Goal Tracking Card. 
4. Metabolic Parameters: Documented with the Type 2 Diabetes Metabolic Parameter 
Tracking 
Form 
and 
Metabolic 
Parameter 
Goal 
Tracking 
Card. 
5. Usability and Acceptability of the Digital DSMES Program: Assessed using the Mobile 
Application Usability Scale (MAUS) among participants in the intervention group. 
Ethical Considerations 
The study protocol has been reviewed and approved by the Akdeniz University Faculty of 
Medicine Clinical Research Ethics Committee (Approval No: TBAEK-1079) and by the 
relevant institutional authorities at Van Regional Training and Research Hospital. All 
participants will be informed about the purpose, procedures, potential risks, and benefits of 

the study and will provide informed consent before enrollment. Participation is voluntary, 
and participants may withdraw from the study at any time without any impact on their 
routine medical care. 
Data confidentiality and privacy will be strictly protected. Personal data and clinical 
information will be stored securely and used only for research purposes in accordance with 
applicable ethical and legal regulations. The study involves a behavioral and educational 
intervention considered to be low risk. Adverse events related to the intervention are not 
expected; however, any unexpected problems will be documented and managed according 
to institutional policies. 
Expected Contribution 
It is anticipated that the nurse-led digital DSMES program will significantly improve 
diabetes self-management behaviors, enhance glycemic control, and reduce diabetes-
related distress in young adults with T2DM compared with standard digital education alone. 
The results of this study may provide evidence to support the integration of nurse-led 
digital DSMES into routine care for young adults with T2DM, contribute to the development 
of innovative education models in diabetes nursing, and inform health policy and clinical 
practice regarding the use of digital health technologies in chronic disease management.