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Technology-Based Education and Follow-Up in Type 2 Diabetes Management (PAS-DM)

A

Alanya Alaaddin Keykubat University

Status

Completed

Conditions

Glycemic Control
Diabetes Self-management
Type 2 Diabetes Mellitus (T2DM)

Treatments

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

Study type

Interventional

Funder types

Other

Identifiers

NCT07513961
PAS-T2DM-RCT-2022

Details and patient eligibility

About

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.

Full 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.

Enrollment

112 patients

Sex

All

Ages

18 to 70 years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Supportive Care

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

112 participants in 2 patient groups

PAS-DM (Technology-Based Diabetes Education and Follow-up System)
Experimental group
Description:
Participants in this arm received a 24-week nurse-led intervention delivered via the Patient Alert System for Diabetes Mellitus (PAS-DM), a technology-based education and follow-up platform. The intervention included structured diabetes education covering five thematic areas: nutrition, physical activity, medication adherence, complication management, and general health monitoring. Participants received automated, standardized educational and reminder messages (maximum 160 characters) every 48 hours between 10:00 and 11:00 AM. The system also enabled continuous remote monitoring, including digital tracking of patient engagement and message interaction through system logs. The intervention was designed to support self-management behaviors through regular prompts, reinforcement, and follow-up.
Treatment:
Behavioral: Technology-Based Diabetes Education and Follow-up System (PAS-DM)
Standard Care
No Intervention group
Description:
Participants in this arm received standard clinical care and routine follow-up provided by the hospital's internal medicine outpatient clinic. This included usual physician consultations, routine monitoring, and standard diabetes management practices. Participants in this group did not receive any technology-based intervention, had no access to the PAS-DM platform, and did not receive structured digital education, reminders, or follow-up messages during the 6-month study period.

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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