Digital Self-Management Education and Support for Young Adults With Type 2 Diabetes (DSMESYAT2DM)

NCT07325838 | Not Yet Recruiting

• 2 other identifiers: DSMES-2025TBAEK-1079
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 1

Brief Summary

This randomized controlled trial will evaluate the effect of a nurse-led digital self-management education and support program on self-management behaviors, glycemic control, and diabetes-related distress in young adults with Type 2 Diabetes Mellitus (T2DM). 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.

Conditions

Type 2 Diabetes Mellitus (T2DM); Diabetes-related Distress; Diabetes Distress

Keywords

Type 2 Diabetes Mellitus; Young Adults; Diabetes Self-Management; Self-Management Education; Digital Health; eHealth; mHealth; Telehealth; Nurse-Led Intervention; Diabetes Distress; Glycemic Control; HbA1c; DSMES (Diabetes Self-Management Education and Support); Diabetes Education; Randomized Controlled Trial; Behavioral Intervention

Outcome Measures

Primary Outcomes (3)

• Change in Diabetes Self-Management Behaviors

  Diabetes self-management behaviors will be assessed using a validated Type 2 Diabetes self-management scale and the ADCES7™ self-care behavior assessment forms. The primary outcome is the change in total self-management score from baseline to the end of the 12-week intervention, comparing the intervention and active control groups.

  Baseline and at 12 weeks after the start of the intervention

• Change in HbA1c

  Glycemic control will be evaluated using glycated hemoglobin (HbA1c) values obtained from hospital laboratory records. The primary outcome is the change in HbA1c (%) from baseline to 12 weeks, comparing the intervention and active control groups.

  Baseline and at 12 weeks after the start of the intervention

• Change in Diabetes Distress

  Diabetes-related distress will be assessed using a validated Diabetes Distress Scale (DDS). The primary outcome is the change in total diabetes distress score from baseline to 12 weeks, comparing the intervention group receiving the digital nurse-led DSMES program with the active control group receiving usual care plus standard digital education.

  Baseline and at 12 weeks after the start of the intervention

Study Arms (2)

Nurse-Led Digital DSMES Program

EXPERIMENTAL

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.

Behavioral: Digital Nurse-Led DSMES Program

Usual Care Plus Standard Digital Education

ACTIVE COMPARATOR

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.

Behavioral: Usual Care Plus Standard Digital Education

Interventions

Digital Nurse-Led DSMES Program BEHAVIORAL

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.

Also known as: Digital DSMES

Nurse-Led Digital DSMES Program

Usual Care Plus Standard Digital Education BEHAVIORAL

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.

Usual Care Plus Standard Digital Education

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Age between 18 and 45 years.
• 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.

You may not qualify if:

• Diagnosis of Type 1 Diabetes Mellitus or gestational diabetes.
• 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.

Sponsors & Collaborators

• Recep Turan: lead

Study Sites (1)

Van Regional Training and Research Hospital, Endocrinology and Metabolism Clinic

Van, 65150, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• HİCRAN BEKTAŞ, PROF. DR.

  Akdeniz University Faculty of Nursing

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Participants will be blinded to their group assignment and will be informed only that they are taking part in a study comparing two types of digital support for Type 2 Diabetes Mellitus. The investigator responsible for statistical analysis and the outcomes assessor will receive de-identified data with coded group labels and will remain unaware of the actual group allocation until all primary analyses are completed.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Internal Medicine Nurse, Principal Investigator

Model Details: A single-center, parallel-group, randomized controlled trial with two arms (intervention and active control). Eligible young adults with Type 2 Diabetes Mellitus will be randomized in a 1:1 ratio, stratified by baseline HbA1c level, to receive either a 12-week nurse-led digital DSMES program or usual care with access to standard digital education materials.

Study Record Dates

• First Submitted: December 18, 2025
• First Posted: January 8, 2026
• Study Start (Estimated): June 16, 2026
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2027
• Last Updated: January 8, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)