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Completed

NCT Number: NCT07513961

Technology-Based Education and Follow-Up in Type 2 Diabetes Management

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.

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Key information

Conditions

Type 2 Diabetes Mellitus (T2DM) Diabetes Mellitus Diabetes Mellitus, Type 2 Diabetes Self-Management Endocrine System Diseases Glucose Metabolism Disorders Glycemic Control Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Alanya Alaaddin Keykubat University Training and Research Hospital, Department of Internal Medicine

Alanya, Antalya, 07400, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Technology-Based Diabetes Education and Follow-up System (PAS-DM)

Behavioral

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.

Primary outcomes

  1. Change in HbA1c (%) from baseline to 6 months

    Time frame: 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 outcomes

  1. Change in Diabetes Self-Management Questionnaire (DSMQ) total score from baseline to 6 months

    Time frame: 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)

Other outcomes

  1. Change in total cholesterol from baseline to 6 months

    Time frame: Baseline to 6 months

    Total cholesterol levels were measured using standard laboratory methods to assess changes in lipid profile.

  2. Change in HDL cholesterol from baseline to 6 months

    Time frame: Baseline to 6 months

    High-density lipoprotein (HDL) cholesterol levels were measured using standard laboratory methods.

  3. Change in LDL cholesterol from baseline to 6 months

    Time frame: Baseline to 6 months

    Low-density lipoprotein (LDL) cholesterol levels were measured using standard laboratory methods.

  4. Change in triglycerides from baseline to 6 months

    Time frame: Baseline to 6 months

    Triglyceride levels were measured using standard laboratory methods.

  5. Change in blood glucose from baseline to 6 months

    Time frame: Baseline to 6 months

    Blood glucose levels were measured using standard laboratory procedures. Measurements were not restricted to fasting conditions.

  6. Change in systolic blood pressure from baseline to 6 months

    Time frame: Baseline to 6 months

    Systolic blood pressure was measured using standardized procedures.

  7. Change in diastolic blood pressure from baseline to 6 months

    Time frame: Baseline to 6 months

    Diastolic blood pressure was measured using standardized procedures.

  8. Change in body mass index (BMI) from baseline to 6 months

    Time frame: Baseline to 6 months

    Body mass index (BMI) was calculated as weight in kilograms divided by height in meters squared (kg/m²) and used to assess changes in body composition.

  9. Change in waist circumference from baseline to 6 months

    Time frame: Baseline to 6 months

    Waist circumference was measured using a standardized method to assess central adiposity.

Sponsors and collaborators

Lead sponsor

Alanya Alaaddin Keykubat University

Other

Registry information

Official study title

The Effect of Technology-Based Education and Follow-Up on Diabetes Management in Individuals With Type 2 Diabetes

Acronym: PAS-DM

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Apr 7, 2026
Registry last updated
Apr 7, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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