Diabetes Self-management, Glycemic Control, Type 2 Diabetes Mellitus (T2DM)
Conditions
Keywords
Type 2 Diabetes Mellitus, Diabetes Management, Technology-Based Education, Glycemic Control, Randomized Controlled Trial, Mobile Health, HbA1c, Patient Education, Nurse-led Intervention
Brief summary
This study aims to evaluate whether a nurse-led, technology-based education and follow-up program can improve diabetes management in individuals with type 2 diabetes. Participants were randomly assigned to two groups. The intervention group received structured diabetes education and ongoing support through a digital system (Patient Follow-up and Diabetes Management System) for six months. This system provided regular reminders and guidance related to medication use, healthy eating, and physical activity. The control group received standard clinical care without additional digital support. The main objective of the study is to determine whether this technology-supported approach can improve blood sugar control (HbA1c), self-management behaviors, and other health outcomes compared to usual care.
Detailed description
This study was designed as a parallel-group randomized controlled trial to evaluate the effectiveness of a nurse-led, technology-based education and follow-up intervention in individuals with type 2 diabetes mellitus. Intervention Group (PAS-DM): Participants assigned to the intervention group received a structured diabetes self-management education program delivered by nurses and supported by a technology-based monitoring system (Patient Follow-up and Diabetes Management System). Following the initial training, participants were monitored for six months through the system, which enabled regular delivery of tailored educational messages, reminders, and behavioral support components. The intervention incorporated key behavior change techniques, including self-monitoring, prompts/reminders, and feedback. Participant engagement and intervention fidelity were objectively tracked through system-generated data (e.g., message delivery and interaction logs). Control Group: Participants in the control group received standard clinical care, including routine outpatient follow-up and standard diabetes education provided by the healthcare institution, without any additional digital or structured intervention. Data Collection and Outcomes: Primary and secondary outcomes included metabolic control parameters (HbA1c, blood glucose, lipid profile, blood pressure, and anthropometric measures) and diabetes self-management behaviors. Measurements were obtained at baseline and at the end of the 6-month follow-up period. The study aimed to compare changes in these outcomes between groups to determine the effectiveness of the nurse-led digital intervention.
Interventions
BEHAVIORALTechnology-Based Diabetes Education and Follow-up System (PAS-DM)
A nurse-led, technology-based diabetes education and follow-up intervention delivered through a three-tier mobile health (mHealth) platform (Android application, C#-based web services, and SQL database). The intervention provides 24 weeks of structured, guideline-based educational content across key domains including nutrition, physical activity, medication adherence, and complication management. Participants receive automated, standardized messages every 48 hours, designed to reinforce self-management behaviors through reminders, prompts, and continuous engagement. The system also enables real-time monitoring of participant interaction (e.g., message delivery and engagement logs), allowing objective assessment of intervention fidelity. This integrated approach combines structured education, behavioral support, and digital follow-up to improve diabetes self-management and metabolic outcomes.
Sponsors
Alanya Alaaddin Keykubat University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Intervention model description
This study was designed as a parallel-assignment randomized controlled trial. Participants were randomly allocated to either the intervention group (receiving a nurse-led, technology-based education and follow-up program via the PAS-DM platform) or the control group (receiving standard clinical care). Randomization was performed using a computer-generated allocation sequence with stratification based on age (\<52 vs ≥52 years) and baseline HbA1c levels (\<8.5% vs ≥8.5%), combined with block randomization to ensure balanced group assignment. Allocation concealment was maintained by using an independent researcher responsible for generating the randomization list. Both groups were followed concurrently over a 6-month period. Outcome assessments were conducted at baseline (0 month) and at the end of the 6th month to evaluate changes between the two groups.
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* Aged between 18 and 70 years. * Diagnosed with Type 2 Diabetes Mellitus for at least 6 months. * Minimum of primary school education. * Using a smartphone with an Android operating system and having internet access. * No visual, hearing, cognitive, or psychiatric impairments. * No major comorbid conditions such as cancer, advanced cardiovascular disease, chronic kidney disease, or liver disease.
Exclusion criteria
* Failure to interact with the educational/reminder messages during the intervention period. * Developing a physical condition that hinders participation in physical activity. * Requesting to withdraw from the study during the follow-up period.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in HbA1c (%) from baseline to 6 months | Baseline to 6 months | Glycemic control was assessed using HbA1c levels obtained from hospital laboratory records. HbA1c reflects average blood glucose levels over the past 2-3 months. Lower values indicate better glycemic control |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Diabetes Self-Management Questionnaire (DSMQ) total score from baseline to 6 months | Baseline to 6 months | A validated 16-item questionnaire assessing diabetes self-management across four domains: glucose management, dietary control, physical activity, and healthcare use. Each item is rated on a 4-point Likert scale. Total scores are transformed to a 0-10 scale, with higher scores indicating better self-management. The validated Turkish version was used in this study, demonstrating high internal consistency (Cronbach's alpha = 0.90) |
Countries
Turkey (Türkiye)
Contacts
PRINCIPAL_INVESTIGATORFadime Yel, PhD
Alanya Alaaddin Keykubat University
STUDY_DIRECTORNuray Enç, Prof. Dr.
Istanbul University-Cerrahpasa, Florence Nightingale Faculty of Nursing
Outcome results
None listed