Type 2 DiabetesNCT06331338
Effects of Using Decision Cycle for Person-Centered Glycemic Management in Type 2 Diabetes
A study testing Decision Cycle for Person-Centered Glycemic Management and Traditional diabetes self-management education in people with Type 2 Diabetes, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial summary
Decision cycle for person-centered glycemic management is a new diabetes decision making .It is defined as a purposefully designed holistic care intervention .The goal is to improve the self-care behavior of patients with type 2 diabetes, thereby improving glycated hemoglobin levels and delaying the occurrence of… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Type 2 Diabetes
- What is being tested?
- Decision Cycle for Person-Centered Glycemic Management and Traditional diabetes self-management education
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 130 participants
- Where
- 1 siteTaiwan
- Study dates
- 14 Feb 2024to 31 Dec 2025
- 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
- Patients diagnosed with type 2 diabetes by a physician.
- Age: 18 years or above.
- Glycated hemoglobin (HbA1c ) test value: 7.5-9.0 %
- No diabetic oral medications, insulin and glucagon-like peptide-1 were replaced in the outpatient when the case was admitted.
- No pregnancy during the study period.
- After the researcher explains the purpose of the research, the research subjects agree to join this researcher.
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- Those who are conscious and able to take care of themselves.
- There is no diagnostic certificate from the American Psychiatric Association's Diagnostic Manual of Mental Disorders, Fourth Edition (DSM-IV)of all mental illnesses.
- Those who can communicate in Mandarin and Taiwanese.
Who cannot join
- Patients diagnosed with type 1 diabetes by a physician.
- Age: Under 18 years old.
- Glycated hemoglobin test value: less than 7.5 % and greater than 9.0 %
- Those who replaced oral diabetes medications, insulin and glucagon-like peptide- 1 at the outpatient at the time of admission.
- Pregnancy during the study period.
- Those who are unable to take care of themselves and express themselves.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Taiwan1 site, 1 recruiting
- Recruiting
National Taiwan University Hospital
Hsinchu, 302
Chia-Hui Tsai, 886926124093, mtsai0322@gmail.com
About this study
Official title: Research on the Effectiveness of Using Decision Cycle for Person-Centered Glycemic Management on Self-Care Behaviors in Outpatients With Type 2 Diabetes
Decision cycle for person-centered glycemic management is a new diabetes decision making .It is defined as a purposefully designed holistic care intervention .The goal is to improve the self-care behavior of patients with type 2 diabetes, thereby improving glycated hemoglobin levels and delaying the occurrence of complications.
Read the detailed description
The "Decision Cycle for Person-Centered Glycemic management" jointly proposed by the American Diabetes Association (ADA) and the European Association for the Study of Diabetes (EASD) in 2018 , which develops treatment goals and plans based on the patient's personal preferences, values, and goals.
Participants will be divided into two groups(treatment group 、control group).Treatment group will accept the "Decision Cycle for Person-Centered Glycemic Management " .It is a person-centered diabetes decision making. Control group will accept the traditional diabetes self-management education. It content focuses more on teaching relevant knowledge and some skills.It is a educator-centered approach.
Baseline / pre-intervention test (after signing informed consent form) post-intervention test (after finishing intervention) Researchers will compare treatment group and control group to see if treatment group has better performance on self-care Behaviors and glycated hemoglobin levels .
- Conditions
- Type 2 Diabetes
- Being tested
- Decision Cycle for Person-Centered Glycemic Management, Traditional diabetes self-management education
- Keywords
- Decision Cycle for Person-Centered Glycemic Management, Self-Care Behaviors, Type 2 Diabetes
- 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.
Decision Cycle for Person-Centered Glycemic ManagementBehavioural
It is defined as a purposefully designed holistic care intervention that improve self-management .
Traditional diabetes self-management educationOther
Traditional diabetes self-management education content focuses more on teaching relevant knowledge and some skills.
| Study group | Role | What they receive |
|---|---|---|
| New health education:use [Decision Cycle for Person-Centered Glycemic Management ] | Experimental | It is a person-centered approach to care. Treatment goals and plans should be cotreated with people with diabetes based on their individual preferences, values, and goals. Receives: Behavioral: Decision Cycle for Person-Centered Glycemic Management |
| Traditional diabetes self-management education | Active comparator | It is a educator-centered approach to care. Receives: Other: Traditional diabetes self-management education |
What is being measured
The primary outcome is the main question the study is designed to answer.
glycemic control (HbA1c)
The HbA1c level is a marker of the average blood glucose levels over a period of the last 2-3 months.
Measured: Before the task and 3 months post intervention
Secondary outcomes (1)
Diabetes Self-Care Behavior Scale
It is contains 20 likert-scaled (1-5) items, it assessed the frequency with which patients performed the diabetes self-care behaviors, including how often took diabetes medications, exercise, blood glucose monitor, diet . A higher score indicates greater self care behavior .
Measured: Before the task and 3 months post intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2024
- Study start14 Feb 2024
- Primary completion31 Oct 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 DiabetesStudies of the same condition, open and under way.
- More trials run by National Taiwan University HospitalThe sponsor's other registered studies.
- 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
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 130 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Kang-Chih Fan, Principal investigator, National Taiwan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06331338
- Sponsor's protocol ID
- 202310085RIND
- Status last verified
- Feb 2025
- First submitted
- 20 Mar 2024
- Last updated
- 12 Feb 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Research on the Effectiveness of Using Decision Cycle for Person-Centered Glycemic Management on Self-Care Behaviors in Outpatients With Type 2 Diabetes
- ClinicalTrials.gov ID
- NCT06331338
- Acronym / sponsor ID
- 202310085RIND
- Conditions
- Type 2 Diabetes
- Keywords
- Decision Cycle for Person-Centered Glycemic Management, Self-Care Behaviors, Type 2 Diabetes
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 130 participants (estimated)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- 14 Feb 2024 (actual)
- Primary completion
- 31 Oct 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 26 Mar 2024 (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.
Decision cycle for person-centered glycemic management is a new diabetes decision making .It is defined as a purposefully designed holistic care intervention .The goal is to improve the self-care behavior of patients with type 2 diabetes, thereby improving glycated hemoglobin levels and delaying the occurrence of complications.
Detailed description
The "Decision Cycle for Person-Centered Glycemic management" jointly proposed by the American Diabetes Association (ADA) and the European Association for the Study of Diabetes (EASD) in 2018 , which develops treatment goals and plans based on the patient's personal preferences, values, and goals.
Participants will be divided into two groups(treatment group 、control group).Treatment group will accept the "Decision Cycle for Person-Centered Glycemic Management " .It is a person-centered diabetes decision making. Control group will accept the traditional diabetes self-management education. It content focuses more on teaching relevant knowledge and some skills.It is a educator-centered approach.
Baseline / pre-intervention test (after signing informed consent form) post-intervention test (after finishing intervention) Researchers will compare treatment group and control group to see if treatment group has better performance on self-care Behaviors and glycated hemoglobin levels .
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| New health education:use [Decision Cycle for Person-Centered Glycemic Management ] | Experimental | Behavioral: Decision Cycle for Person-Centered Glycemic ManagementIt is a person-centered approach to care. Treatment goals and plans should be cotreated with people with diabetes based on their individual preferences, values, and goals. |
| Traditional diabetes self-management education | Active comparator | Other: Traditional diabetes self-management educationIt is a educator-centered approach to care. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Patients diagnosed with type 2 diabetes by a physician.
- Age: 18 years or above.
- Glycated hemoglobin (HbA1c ) test value: 7.5-9.0 %
- No diabetic oral medications, insulin and glucagon-like peptide-1 were replaced in the outpatient when the case was admitted.
- No pregnancy during the study period.
Key exclusion criteria (6 listed)
- Patients diagnosed with type 1 diabetes by a physician.
- Age: Under 18 years old.
- Glycated hemoglobin test value: less than 7.5 % and greater than 9.0 %
- Those who replaced oral diabetes medications, insulin and glucagon-like peptide- 1 at the outpatient at the time of admission.
- Pregnancy during the study 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 |
|---|---|---|
| Decision Cycle for Person-Centered Glycemic ManagementIt is defined as a purposefully designed holistic care intervention that improve self-management . | Behavioural | New health education:use [Decision Cycle for Person-Centered Glycemic Management ] |
| Traditional diabetes self-management educationTraditional diabetes self-management education content focuses more on teaching relevant knowledge and some skills. | Other | Traditional diabetes self-management education |
Primary outcome
glycemic control (HbA1c)
Time frame: Before the task and 3 months post intervention
The HbA1c level is a marker of the average blood glucose levels over a period of the last 2-3 months.
1 secondary outcome
Diabetes Self-Care Behavior Scale
Time frame: Before the task and 3 months post intervention
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 12 Feb 2025.
- Individual participant dataSharing planned: No
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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.
Kang-Chih Fan principal investigator
National Taiwan University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Decision Cycle for Person-Centered Glycemic Management and Traditional diabetes self-management education in people with Type 2 Diabetes, run by National Taiwan University Hospital at 1 site in Taiwan.
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 9 inclusion and 6 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: looking for participants now, as of the sponsor's last update on 12 Feb 2025. 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 Taiwan. 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?
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?
Contact Chia-Hui Tsai (886926124093, mtsai0322@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
glycemic control (HbA1c) (time frame: Before the task and 3 months post intervention). 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 12 Feb 2025.