Technology-Based Education and Follow-Up in Type 2 Diabetes Management (PAS-DM)
The Effect of Technology-Based Education and Follow-Up on Diabetes Management in Individuals With Type 2 Diabetes
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.
Study Overview
Status
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Antalya
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Alanya, Antalya, Turkey (Türkiye), 07400
- Alanya Alaaddin Keykubat University Training and Research Hospital, Department of Internal Medicine
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Experimental: PAS-DM (Technology-Based Diabetes Education and Follow-up System)
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.
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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.
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No Intervention: Standard Care
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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Change in HbA1c (%) from baseline to 6 months
Time Frame: Baseline to 6 months
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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
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Baseline to 6 months
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in Diabetes Self-Management Questionnaire (DSMQ) total score from baseline to 6 months
Time Frame: Baseline to 6 months
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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)
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Baseline to 6 months
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Change in total cholesterol from baseline to 6 months
Time Frame: Baseline to 6 months
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Total cholesterol levels were measured using standard laboratory methods to assess changes in lipid profile.
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Baseline to 6 months
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Change in HDL cholesterol from baseline to 6 months
Time Frame: Baseline to 6 months
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High-density lipoprotein (HDL) cholesterol levels were measured using standard laboratory methods.
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Baseline to 6 months
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Change in LDL cholesterol from baseline to 6 months
Time Frame: Baseline to 6 months
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Low-density lipoprotein (LDL) cholesterol levels were measured using standard laboratory methods.
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Baseline to 6 months
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Change in triglycerides from baseline to 6 months
Time Frame: Baseline to 6 months
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Triglyceride levels were measured using standard laboratory methods.
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Baseline to 6 months
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Change in blood glucose from baseline to 6 months
Time Frame: Baseline to 6 months
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Blood glucose levels were measured using standard laboratory procedures.
Measurements were not restricted to fasting conditions.
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Baseline to 6 months
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Change in systolic blood pressure from baseline to 6 months
Time Frame: Baseline to 6 months
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Systolic blood pressure was measured using standardized procedures.
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Baseline to 6 months
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Change in diastolic blood pressure from baseline to 6 months
Time Frame: Baseline to 6 months
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Diastolic blood pressure was measured using standardized procedures.
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Baseline to 6 months
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Change in body mass index (BMI) from baseline to 6 months
Time Frame: Baseline to 6 months
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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.
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Baseline to 6 months
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Change in waist circumference from baseline to 6 months
Time Frame: Baseline to 6 months
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Waist circumference was measured using a standardized method to assess central adiposity.
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Baseline to 6 months
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Collaborators and Investigators
Investigators
- Principal Investigator: Fadime Yel, PhD, Alanya Alaaddin Keykubat University
- Study Director: Nuray Enç, Prof. Dr., Istanbul University-Cerrahpasa, Florence Nightingale Faculty of Nursing
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- PAS-T2DM-RCT-2022
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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