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

About this trial

Last updated 5 months ago

Study ID

DSMES-2025

Status

Not yet recruiting

Type

Interventional

Phase

N/A

Placebo

Accepting

18 to 45 Years

All Sexes

Trial Timing

Starts in 12 days

What is this trial about?

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.

What are the participation requirements?

Inclusion Criteria

* 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.

Exclusion Criteria

* 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.