Type 2 Diabetes Mellitus (T2DM)PAS-DMNCT07513961
Technology-Based Education and Follow-Up in Type 2 Diabetes Management
A study testing Technology-Based Diabetes Education and Follow-up System (PAS-DM) in people with Type 2 Diabetes Mellitus (T2DM) and Diabetes Self-management, run by Alanya Alaaddin Keykubat University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Type 2 Diabetes Mellitus (T2DM), Diabetes Self-management, Glycemic Control
- What is being tested?
- Technology-Based Diabetes Education and Follow-up System (PAS-DM)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 112 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Mar 2021to 15 Mar 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Alanya Alaaddin Keykubat University Training and Research Hospital, Department of Internal Medicine
Alanya, Antalya, 07400
About this study
Official title: 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.
Read the 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.
- Being tested
- Technology-Based Diabetes Education and Follow-up System (PAS-DM)
- Keywords
- Type 2 Diabetes Mellitus, Diabetes Management, Technology-Based Education, Glycemic Control, Randomized Controlled Trial, Mobile Health, HbA1c, Patient Education, Nurse-led Intervention
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Technology-Based Diabetes Education and Follow-up System (PAS-DM)Behavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| PAS-DM (Technology-Based Diabetes Education and Follow-up System) | Experimental | 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. Receives: Behavioral: Technology-Based Diabetes Education and Follow-up System (PAS-DM) |
| Standard Care | No intervention | 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in HbA1c (%) from 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
Measured: Baseline to 6 months
Secondary outcomes (1)
Change in Diabetes Self-Management Questionnaire (DSMQ) total score from 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)
Measured: Baseline to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Apr 2026
- Study start15 Mar 2021
- Primary completion15 Mar 2022
- Study completion15 Mar 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 Diabetes Mellitus (T2DM)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- None (open label)
- Enrolment
- 112 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alanya Alaaddin Keykubat University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fadime Yel, Alanya Alaaddin Keykubat University
- Investigators
- Fadime Yel, PhD, Principal investigator, Alanya Alaaddin Keykubat UniversityNuray Enç, Prof. Dr., Study director, Istanbul University-Cerrahpasa, Florence Nightingale Faculty of Nursing
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07513961
- Sponsor's protocol ID
- PAS-T2DM-RCT-2022
- Acronym
- PAS-DM
- Status last verified
- Apr 2026
- First submitted
- 28 Mar 2026
- Last updated
- 7 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data (IPD) will not be shared due to institutional data privacy policies and the Turkish Personal Data Protection Law (KVKK). In addition, participants did not provide explicit consent for public sharing of their individual-level data. However, de-identified aggregate data and statistical results supporting the findings of this study will be made available upon reasonable request to the corresponding author.
Study at a glance
From the registry record, last updated by the sponsor on 7 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Technology-Based Education and Follow-Up on Diabetes Management in Individuals With Type 2 Diabetes
- ClinicalTrials.gov ID
- NCT07513961
- Acronym / sponsor ID
- PAS-DM / PAS-T2DM-RCT-2022
- Keywords
- Type 2 Diabetes Mellitus, Diabetes Management, Technology-Based Education, Glycemic Control, Randomized Controlled Trial, Mobile Health, HbA1c, Patient Education
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 112 participants (actual)
- Lead sponsor
- Alanya Alaaddin Keykubat UniversityUniversity, hospital or other
- Study start
- 15 Mar 2021 (actual)
- Primary completion
- 15 Mar 2022 (actual)
- Study completion
- 15 Mar 2022 (actual)
- First posted
- 7 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| PAS-DM (Technology-Based Diabetes Education and Follow-up System) | Experimental | Behavioral: Technology-Based Diabetes Education and Follow-up System (PAS-DM)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. |
| Standard Care | No intervention | –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. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Technology-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. | Behavioural | PAS-DM (Technology-Based Diabetes Education and Follow-up System) |
Primary outcome
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
1 secondary outcome
Change in Diabetes Self-Management Questionnaire (DSMQ) total score from baseline to 6 months
Time frame: Baseline to 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Apr 2026.
- Individual participant dataSharing planned: No. Individual participant data (IPD) will not be shared due to institutional data privacy policies and the Turkish Personal Data Protection Law (KVKK). In addition, participants did not provide explicit consent for public sharing of their individual-level data. However, de-identified aggregate data and statistical results supporting the findings of this study will be made available upon reasonable request to the corresponding author.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Fadime Yel, PhD principal investigator
Alanya Alaaddin Keykubat University
Nuray Enç, Prof. Dr. study director
Istanbul University-Cerrahpasa, Florence Nightingale Faculty of Nursing
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Technology-Based Diabetes Education and Follow-up System (PAS-DM) in people with Type 2 Diabetes Mellitus (T2DM) and Diabetes Self-management, run by Alanya Alaaddin Keykubat University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in HbA1c (%) from baseline to 6 months (time frame: Baseline to 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Apr 2026.