Type 2 Diabetes Mellitus (T2DM)ApplicationNCT07794384
Effects of a Researcher-Designed Diabetes Self-Management App on Self-Management Obstacles, Self-Efficacy, and Physiological Indicators in Type 2 Diabetes
A study testing Researcher-Designed Diabetes Self-Management Application in people with Type 2 Diabetes Mellitus (T2DM) and Self-management, run by Fu Jen Catholic University Hospital.
Trial summary
This study aims to evaluate the effectiveness of a self-developed diabetes self-management mobile application on disease self-management outcomes among individuals with type 2 diabetes. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Type 2 Diabetes Mellitus (T2DM), Self-management
- What is being tested?
- Researcher-Designed Diabetes Self-Management Application
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- No sites listed yet
- Study dates
- 1 Sep 2026to 31 Jul 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosed with type 2 diabetes for more than 6 months and Hemoglobin A1c (HbA1c) > 7.5%.
- Having diabetes self-management obstacles.
- Aged 18 years or older.
- Conscious and able to communicate.
- Having a smartphone with internet access.
- Willing to participate in the study and provide written informed consent.
Who cannot join
- Gestational diabetes mellitus.
- Currently taking steroid medications.
- Having a severe infection requiring hospitalization within the past 6 months.
- Unable to perform self-care independently.
- Having participated in or currently participating in an educational program of a similar nature.
About this study
Official title: Construction and Evaluation of a Self-management APP for Effectiveness in Self-Management, Self-Efficacy, and Metabolic Indicators of Patients With Type 2 Diabetes.
This study aims to evaluate the effectiveness of a self-developed diabetes self-management mobile application on disease self-management outcomes among individuals with type 2 diabetes.
- Conditions
- Type 2 Diabetes Mellitus (T2DM), Self-management
- Being tested
- Researcher-Designed Diabetes Self-Management Application
- Keywords
- Diabetes self-management, Diabetes Obstacles, Self-efficacy, Metabolic indicators
- 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.
Researcher-Designed Diabetes Self-Management ApplicationBehavioural
Participants in the intervention group will receive routine diabetes care and use the enhanced diabetes self-management mobile application. In addition to the basic self-management recording functions, the intervention group will receive video-based health education and multidisciplinary team care through the application. The multidisciplinary team may include healthcare professionals such as physicians, nurses, dietitians, and pharmacists, who provide diabetes-related guidance to support daily self-management, self-efficacy, and metabolic control.
| Study group | Role | What they receive |
|---|---|---|
| Basic self-management mobile application use. | No intervention | Participants in the control group will receive routine diabetes care and use the basic functions of the diabetes self-management mobile application. The basic app functions include self-recording of blood glucose, medication, diet, physical activity, and related health information. Participants in this group will not receive additional video-based health education or multidisciplinary team care through the application. |
| Enhanced diabetes self-management mobile application use. | Experimental | Participants in the intervention group will receive routine diabetes care and access to an enhanced diabetes self-management mobile application, which includes basic self-management recording functions, video-based health education, and multidisciplinary team care to support diabetes self-management. Receives: Behavioral: Researcher-Designed Diabetes Self-Management Application |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diabetes management self-efficacy
- The Chinese version of the Diabetes Management Self-Efficacy Scale(C-DMSES) includes 20 items across four subscales:
- Nutrition: 9 items
- Physical activity and weight control: 4 items
- Medication treatment: 3 items
- Blood glucose and foot care: 4 items
- Scores range from 0 to 10.
- The scale has good reliability, with an overall Cronbach's α of .93.
- Subscale Cronbach's α values range from .77 to .93.
- The scale also has good test-retest reliability, with Pearson's r = .86, p < .01.
Measured: Baseline, 3 months, and 6 months.
Diabetes self-management obstacles
Diabetes self-management obstacles will be measured using the Chinese Version of the Diabetes Obstacles Questionnaire-Short Form (CDOQ-S). Each item is rated on a 5-point Likert scale, ranging from 1 to 5. The items are negatively scored, and higher scores indicate greater obstacles in diabetes self-management.
Measured: Baseline, 3 months, and 6 months.
Secondary outcomes (6)
HbA1c
Glycated hemoglobin (HbA1c) will be measured using laboratory blood tests and reported as a percentage (%)
Measured: Baseline, 3 months, and 6 months
Fasting plasma glucose
Fasting plasma glucose will be measured using laboratory blood tests and reported in milligrams per deciliter (mg/dL).
Measured: Baseline, 3months, and 6months
Triglycerides
Serum triglyceride levels will be measured using laboratory blood tests and reported in milligrams per deciliter (mg/dL).
Measured: Baseline, 3months, and 6 months
Total cholesterol
Serum total cholesterol levels will be measured using laboratory blood tests and reported in milligrams per deciliter (mg/dL).
Measured: Baseline, 3 months, and 6 months.
LDL
Serum low-density lipoprotein cholesterol will be measured using laboratory blood tests and reported in milligrams per deciliter (mg/dL).
Measured: Baseline, 3 months, and 6 months.
HDL
Serum high-density lipoprotein cholesterol will be measured using laboratory blood tests and reported in milligrams per deciliter (mg/dL).
Measured: Baseline, 3 months, and 6 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2026
- Study start1 Sep 2026 (estimated)
- Primary completion31 Jul 2028 (estimated)
- Study completion31 Jul 2028 (estimated)
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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This is a two-arm, parallel-group randomized controlled trial. Participants will be assigned to either the control group or the intervention group. Both groups will use a diabetes self-management mobile application. The intervention group will receive additional video-based health education and multidisciplinary team care through the application.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fu Jen Catholic University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, SZU-YI WANG, Fu Jen Catholic University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07794384
- Sponsor's protocol ID
- FJUH114464
- Acronym
- Application
- Status last verified
- Aug 2026
- First submitted
- 24 Aug 2026
- Last updated
- 31 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Construction and Evaluation of a Self-management APP for Effectiveness in Self-Management, Self-Efficacy, and Metabolic Indicators of Patients With Type 2 Diabetes.
- ClinicalTrials.gov ID
- NCT07794384
- Acronym / sponsor ID
- Application / FJUH114464
- Conditions
- Type 2 Diabetes Mellitus (T2DM), Self-management
- Keywords
- Diabetes self-management, Diabetes Obstacles, Self-efficacy, Metabolic indicators
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Fu Jen Catholic University HospitalUniversity, hospital or other
- Study start
- 1 Sep 2026 (estimated)
- Primary completion
- 31 Jul 2028 (estimated)
- Study completion
- 31 Jul 2028 (estimated)
- First posted
- 31 Aug 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 the effectiveness of a self-developed diabetes self-management mobile application on disease self-management outcomes among individuals with type 2 diabetes.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- This is a two-arm, parallel-group randomized controlled trial. Participants will be assigned to either the control group or the intervention group. Both groups will use a diabetes self-management mobile application. The intervention group will receive additional video-based health education and multidisciplinary team care through the application.
| Arm | Type | Receives |
|---|---|---|
| Basic self-management mobile application use. | No intervention | –Participants in the control group will receive routine diabetes care and use the basic functions of the diabetes self-management mobile application. The basic app functions include self-recording of blood glucose, medication, diet, physical activity, and related health information. Participants in this group will not receive additional video-based health education or multidisciplinary team care through the application. |
| Enhanced diabetes self-management mobile application use. | Experimental | Behavioral: Researcher-Designed Diabetes Self-Management ApplicationParticipants in the intervention group will receive routine diabetes care and access to an enhanced diabetes self-management mobile application, which includes basic self-management recording functions, video-based health education, and multidisciplinary team care to support diabetes self-management. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Diagnosed with type 2 diabetes for more than 6 months and Hemoglobin A1c (HbA1c) > 7.5%.
- Having diabetes self-management obstacles.
- Aged 18 years or older.
- Conscious and able to communicate.
- Having a smartphone with internet access.
Key exclusion criteria (5 listed)
- Gestational diabetes mellitus.
- Currently taking steroid medications.
- Having a severe infection requiring hospitalization within the past 6 months.
- Unable to perform self-care independently.
- Having participated in or currently participating in an educational program of a similar nature.
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 |
|---|---|---|
| Researcher-Designed Diabetes Self-Management ApplicationParticipants in the intervention group will receive routine diabetes care and use the enhanced diabetes self-management mobile application. In addition to the basic self-management recording functions, the intervention group will receive video-based health education and multidisciplinary team care through the application. The multidisciplinary team may include healthcare professionals such as physicians, nurses, dietitians, and pharmacists, who provide diabetes-related guidance to support daily self-management, self-efficacy, and metabolic control. | Behavioural | Enhanced diabetes self-management mobile application use. |
Primary outcome
Diabetes management self-efficacy
Time frame: Baseline, 3 months, and 6 months.
1. The Chinese version of the Diabetes Management Self-Efficacy Scale(C-DMSES) includes 20 items across four subscales: 1. Nutrition: 9 items 2. Physical activity and weight control: 4 items 3. Medication treatment: 3 items 4. Blood glucose and foot care: 4 items 2. Scores range from 0 to 10. 3. The scale has good reliability, with an overall Cronbach's α of .93. 4. Subscale Cronbach's α values range from .77 to .93. 5. The scale also has good test-retest reliability, with Pearson's r = .86, p < .01.
Diabetes self-management obstacles
Time frame: Baseline, 3 months, and 6 months.
Diabetes self-management obstacles will be measured using the Chinese Version of the Diabetes Obstacles Questionnaire-Short Form (CDOQ-S). Each item is rated on a 5-point Likert scale, ranging from 1 to 5. The items are negatively scored, and higher scores indicate greater obstacles in diabetes self-management.
6 secondary outcomes
HbA1c
Time frame: Baseline, 3 months, and 6 months
Fasting plasma glucose
Time frame: Baseline, 3months, and 6months
Triglycerides
Time frame: Baseline, 3months, and 6 months
Total cholesterol
Time frame: Baseline, 3 months, and 6 months.
LDL
Time frame: Baseline, 3 months, and 6 months.
HDL
Time frame: Baseline, 3 months, and 6 months.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Aug 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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Researcher-Designed Diabetes Self-Management Application in people with Type 2 Diabetes Mellitus (T2DM) and Self-management, run by Fu Jen Catholic University Hospital.
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 5 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: opening soon, as of the sponsor's last update on 31 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
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?
Diabetes management self-efficacy (time frame: Baseline, 3 months, and 6 months.). The study lists 2 primary outcomes in all. 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 31 Aug 2026.