Type 2 Diabetes Mellitus (T2DM)NCT07366775
A Telenursing Program to Support Diabetes Self-Management
A study testing Telenursing-Based Diabetes Self-Management Education and Support in people with Type 2 Diabetes Mellitus (T2DM), run by Chiang Mai University at 1 site in Thailand.
Trial summary
This randomized controlled trial aims to develop and evaluate a telenursing-based Diabetes Self-Management Education and Support (DSMES) program with uncontrolled type 2 diabetes mellitus in Thailand. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Type 2 Diabetes Mellitus (T2DM)
- What is being tested?
- Telenursing-Based Diabetes Self-Management Education and Support
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 128 participants
- Where
- 1 siteThailand
- Study dates
- 25 Feb 2026to 8 Jun 2026
- 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 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- People with T2DM
- Adults (age 20-64) and older adults (65 and above)
- Uncontrolled diabetes, as determined by physician based on the diagnostic criteria of HbA1C > 7%
- Can read and write
- Own a smartphone
- Having internet connectivity
- Able to receive a video call or with assistance from a caregiver
Who cannot join
- Insulin-dependent patients
- Cognitive or mobility impairments , as assessed by the Thai Mental State Examination (TMSE). A TMSE score below 24 was considered indicative of cognitive impairment (The Nurse Association of Thailand, 2025).
- Requiring special nursing care, such as patients with severe diabetic complications or those who are bedridden.
- Previous extensive DSMES exposure
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Development of Telenursing for Diabetes Self-Management Education and Support (DSMES) Among Patients With Type 2 Diabetes Mellitus in Thailand: A Randomized Controlled Trial
This randomized controlled trial aims to develop and evaluate a telenursing-based Diabetes Self-Management Education and Support (DSMES) program with uncontrolled type 2 diabetes mellitus in Thailand. The program is designed to improve diabetes self-management through nurse-led education, behavioral support, and regular follow-up delivered via telecommunication technologies.
Participants with type 2 diabetes and poor glycemic control will be randomly assigned to either an intervention group receiving a 12-week telenursing DSMES program or a control group receiving usual care. The intervention includes an initial in-person education session followed by structured video call follow-ups provided by nurse.
The primary outcome of this study is the feasibility of implementing telenursing for DSMES in Thailand. Secondary outcomes include changes in glycemic control (HbA1C , FBG), blood pressure, body mass index, diabetes knowledge, self-care behaviors, coping behaviors, quality of life, healthcare costs, and frequency of acute care use. The findings from this study are expected to provide evidence to support the use of telenursing as an accessible and sustainable approach for diabetes self-management in the Thai healthcare context.
- Conditions
- Type 2 Diabetes Mellitus (T2DM)
- Being tested
- Telenursing-Based Diabetes Self-Management Education and Support
- 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.
Telenursing-Based Diabetes Self-Management Education and SupportBehavioural
This intervention is a nurse-led, telenursing-based Diabetes Self-Management Education and Support (DSMES) program delivered over a 12-week period. It includes an initial face-to-face diabetes education session followed by scheduled follow-up sessions conducted via video calls. The program focuses on improving diabetes self-management through education, behavioral support, goal setting, problem-solving, and ongoing monitoring tailored to individual patient needs.
| Study group | Role | What they receive |
|---|---|---|
| Telenursing-Based DSMES Program | Experimental | Not described Receives: Behavioral: Telenursing-Based Diabetes Self-Management Education and Support |
| Usual care | No intervention | control group : receive usual care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility of telenursing for diabetes self-management education and support (DSMES)
Feasibility outcomes, including participation rate, completion rate, and adherence level, were analyzed using descriptive statistics under the per-protocol (PP) approach, which included only participants who completed all study assessments.
Measured: at 12-week follow-up period after enrollment
Secondary outcomes (11)
Glycated hemoglobin (HbA1c) level
HbA1c (%) will be measured using standard laboratory methods obtained from medical records at baseline and 12 weeks after enrollment to assess changes over time.
Measured: From baseline to 12 weeks after enrollment
Fasting Blood Glucose (FBG)
FBG (mg/dl) will be measured using standard laboratory methods obtained from medical records at baseline and 12 weeks after enrollment to assess changes over time.
Measured: From baseline to 12 weeks after enrollment
Blood pressure (BP)
Blood pressure will be obtained from health assessment record at baseline and 12 weeks after enrollment to assess changes over time.
Measured: From baseline to 12 weeks after enrollment
Body Mass Index (BMI)
Body mass index (kg/m²) will be calculated from measured weight and height obtained from health assessment record at baseline and 12 weeks after enrollment to assess changes over time.
Measured: From baseline to 12 weeks after enrollment
Diabetes knowledge
Diabetes knowledge will be assessed using the Thai version of the Diabetes Knowledge Scale (DIAKS), consisting of 21 items with true, false, or don't know response options. Total scores will be calculated based on the number of correct responses. Assessments will be conducted at baseline, 6 weeks, and 12 weeks after enrollment to assess changes over time.
Measured: From baseline to 6 weeks and 12 weeks after enrollment
Self-care behavior
Self-care behavior will be assessed using the Thai Diabetes Self-Management Questionnaire-Revised (T-DSMQ-R). Total scores will be calculated according to standard scoring procedures, with higher scores indicating better diabetes self-management. Assessments will be conducted at baseline, 6 weeks, and 12 weeks after enrollment to assess changes over time.
Measured: From baseline to 6 weeks and 12 weeks after enrollment
Positive coping behavior
Positive coping behavior will be assessed using the Short Thai Stress Test (ST-5), a five-item questionnaire rated on a 0-3 Likert scale. Total scores range from 0 to 15, with higher scores indicating greater stress severity. Assessments will be conducted at baseline, 6 weeks, and 12 weeks after enrollment to assess changes over time.
Measured: From baseline to 6 weeks and 12 weeks after enrollment
Quality of life (QoL)
Quality of life will be assessed using the Thai version of the Audit of Diabetes-Dependent Quality of Life (ADDQoL19). The average weighted impact (AWI) score will be calculated, with scores ranging from -9 to +3. Assessments will be conducted at baseline, 6 weeks, and 12 weeks after enrollment to assess changes over time.
Measured: From baseline to 6 weeks and 12 weeks after enrollment
Healthcare costs
Healthcare costs will be assessed through review of medical and financial records, including outpatient visits, inpatient admissions, medications, laboratory tests, and other diabetes-related expenses. Total healthcare costs per participant will be summarized for the 12-week follow-up period.
Measured: at 12-week follow-up period after enrollment
Frequency of acute care use
Frequency of acute care use will be assessed using hospital records, including emergency department visits and hospital admissions. The total number of acute care events per participant will be recorded during the follow-up period.
Measured: at 12-week follow-up period after enrollment
All-cause mortality
All-cause mortality will be assessed using hospital follow-up records. Mortality status will be recorded for each participant during the follow-up period.
Measured: at 12-week follow-up period after enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2026
- Study start25 Feb 2026
- Primary completion8 Jun 2026
- Study completion8 Jun 2026
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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 128 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chiang Mai University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ramida Subpaiboonkit, Chiang Mai University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07366775
- Sponsor's protocol ID
- 2568-EXP092
- Status last verified
- Jun 2026
- First submitted
- 7 Jan 2026
- Last updated
- 26 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development of Telenursing for Diabetes Self-Management Education and Support (DSMES) Among Patients With Type 2 Diabetes Mellitus in Thailand: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07366775
- Acronym / sponsor ID
- 2568-EXP092
- Conditions
- Type 2 Diabetes Mellitus (T2DM)
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 128 participants (actual)
- Lead sponsor
- Chiang Mai UniversityUniversity, hospital or other
- Study start
- 25 Feb 2026 (actual)
- Primary completion
- 8 Jun 2026 (actual)
- Study completion
- 8 Jun 2026 (actual)
- First posted
- 26 Jan 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 randomized controlled trial aims to develop and evaluate a telenursing-based Diabetes Self-Management Education and Support (DSMES) program with uncontrolled type 2 diabetes mellitus in Thailand. The program is designed to improve diabetes self-management through nurse-led education, behavioral support, and regular follow-up delivered via telecommunication technologies.
Participants with type 2 diabetes and poor glycemic control will be randomly assigned to either an intervention group receiving a 12-week telenursing DSMES program or a control group receiving usual care. The intervention includes an initial in-person education session followed by structured video call follow-ups provided by nurse.
The primary outcome of this study is the feasibility of implementing telenursing for DSMES in Thailand. Secondary outcomes include changes in glycemic control (HbA1C , FBG), blood pressure, body mass index, diabetes knowledge, self-care behaviors, coping behaviors, quality of life, healthcare costs, and frequency of acute care use. The findings from this study are expected to provide evidence to support the use of telenursing as an accessible and sustainable approach for diabetes self-management in the Thai healthcare context.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Telenursing-Based DSMES Program | Experimental | Behavioral: Telenursing-Based Diabetes Self-Management Education and Support |
| Usual care | No intervention | –control group : receive usual care |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- People with T2DM
- Adults (age 20-64) and older adults (65 and above)
- Uncontrolled diabetes, as determined by physician based on the diagnostic criteria of HbA1C > 7%
- Can read and write
- Own a smartphone
Key exclusion criteria (4 listed)
- Insulin-dependent patients
- Cognitive or mobility impairments , as assessed by the Thai Mental State Examination (TMSE). A TMSE score below 24 was considered indicative of cognitive impairment (The Nurse Association of Thailand, 2025).
- Requiring special nursing care, such as patients with severe diabetic complications or those who are bedridden.
- Previous extensive DSMES exposure
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 |
|---|---|---|
| Telenursing-Based Diabetes Self-Management Education and SupportThis intervention is a nurse-led, telenursing-based Diabetes Self-Management Education and Support (DSMES) program delivered over a 12-week period. It includes an initial face-to-face diabetes education session followed by scheduled follow-up sessions conducted via video calls. The program focuses on improving diabetes self-management through education, behavioral support, goal setting, problem-solving, and ongoing monitoring tailored to individual patient needs. | Behavioural | Telenursing-Based DSMES Program |
Primary outcome
Feasibility of telenursing for diabetes self-management education and support (DSMES)
Time frame: at 12-week follow-up period after enrollment
Feasibility outcomes, including participation rate, completion rate, and adherence level, were analyzed using descriptive statistics under the per-protocol (PP) approach, which included only participants who completed all study assessments.
11 secondary outcomes
Glycated hemoglobin (HbA1c) level
Time frame: From baseline to 12 weeks after enrollment
Fasting Blood Glucose (FBG)
Time frame: From baseline to 12 weeks after enrollment
Blood pressure (BP)
Time frame: From baseline to 12 weeks after enrollment
Body Mass Index (BMI)
Time frame: From baseline to 12 weeks after enrollment
Diabetes knowledge
Time frame: From baseline to 6 weeks and 12 weeks after enrollment
Self-care behavior
Time frame: From baseline to 6 weeks and 12 weeks after enrollment
Positive coping behavior
Time frame: From baseline to 6 weeks and 12 weeks after enrollment
Quality of life (QoL)
Time frame: From baseline to 6 weeks and 12 weeks after enrollment
Healthcare costs
Time frame: at 12-week follow-up period after enrollment
Frequency of acute care use
Time frame: at 12-week follow-up period after enrollment
All-cause mortality
Time frame: at 12-week follow-up period after enrollment
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 26 Jun 2026.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Telenursing-Based Diabetes Self-Management Education and Support in people with Type 2 Diabetes Mellitus (T2DM), run by Chiang Mai University at 1 site in Thailand.
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 7 inclusion and 4 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 26 Jun 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 Thailand. 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?
Feasibility of telenursing for diabetes self-management education and support (DSMES) (time frame: at 12-week follow-up period after enrollment). 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 26 Jun 2026.