Diabetes Mellitus, Type 2SDMNCT07810647
Effectiveness of Shared Decision Making（SDM）on Patients With Poor Control Type 2 Diabetes
A study testing SDM in people with Diabetes Mellitus, Type 2, run by Fooyin University at 1 site in Taiwan.
Trial summary
The study is a pilot study, using a convenient sampling method, targeting at outpatient patients with type 2 diabetes who participate in the diabetes co-care program and poor blood sugar control as the research subjects, and randomly assigned. The number of samples is expected to receive 30 patients in each group. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Diabetes Mellitus, Type 2
- What is being tested?
- SDM
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteTaiwan
- Study dates
- 12 May 2020to 30 Jun 2021
- 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
- Aged>20y/o
- Diagnosed by a physician as type 2 diabetes
- The Diabetes Participated in the Diabetes Shared Care Network
- Glycosylated hemoglobin (A1C)> 7.5%
- Can communicate in Chinese or Taiwanese.
Who cannot join
- People with mental or cognitive impairment who cannot communicate
- Health Literacy score lower than 6 points
Trial locations and contacts
1 site in 1 country.
About this study
The study is a pilot study, using a convenient sampling method, targeting at outpatient patients with type 2 diabetes who participate in the diabetes co-care program and poor blood sugar control as the research subjects, and randomly assigned. The number of samples is expected to receive 30 patients in each group. The attrition rate estimates about 20%, so there should be 76 people in total, and 38 people in each group. The experimental group was involved in SDM health education; the control group was involved in routine health education. After the implementation of the measures, the self-efficacy and health promotion behavior changes of the two groups and the effectiveness of disease control (glycated hemoglobin, body mass index, waist circumference) were tracked.
Read the detailed description
Background Diabetes and hyperglycemia not only increase the risk of complications of cardiovascular disease and lead to a situation involving exposure to danger of death. Meanwhile, the patient's self-management is one of the key factors affecting the quality control of blood sugar. Thereby, Shared Decision Making (SDM) is a patient-centered medical implementation method that healthcare professionals and patients jointly participate in treatment decision-making to reach a consensus, which can stimulate the health care ability of participants to achieve treatment goals.
Purpose： This research aims to implement the SDM model based on self-efficacy theory through individualized decision-making to strengthen the behavioral motivation of diabetic patients and finally, to improve the patient's health promotion behavior and the effectiveness of blood sugar control.
Method： Study Type: Interventional Actual Enrollment:76 participants Allocation:Randomized Intervention Model:Parallel Assignment Masking:Single(Participant)
Expected results:
It is hoped that the implementation of SDM model will be used to strengthen the behavioral motivation of diabetic patients through individualized decision-making, and to confirm whether it can effectively improve the patient's health behavior and the effectiveness of disease control.
- Conditions
- Diabetes Mellitus, Type 2
- Being tested
- SDM
- 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.
SDMBehavioural
The experimental group received the intervention of SDM 3times/month for 3months, then follow the health promotion behavior compliance by phone once a month.
| Study group | Role | What they receive |
|---|---|---|
| Control group:as usual care | No intervention | The control group received as usual care. |
| Experimental group:The intervention of SDM | Experimental | The experimental group received the intervention of SDM 3 times for 3 months, Receives: Behavioral: SDM |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diabetes self-efficacy scale
assesses the confidence of diabetes patients in their ability to manage their diet, blood sugar, and physical exercise
Measured: Pre-test (baseline)
Diabetes self-efficacy scale
assesses the confidence of diabetes patients in their ability to manage their diet, blood sugar, and physical exercise
Measured: 1 months after intervnetion
Diabetes self-efficacy scale
assesses the confidence of diabetes patients in their ability to manage their diet, blood sugar, and physical exercise
Measured: 3 months after intervnetion
Diabetes health literacy scale
A disease-specific scale to measure functional, communicative and critical health literacy in primary care
Measured: Pre-test (baseline)
Diabetes health literacy scale
A disease-specific scale to measure functional, communicative and critical health literacy in primary care
Measured: 3 months after intervnetion
Diabetes health promotion scale
A self-report study instrument that includes the health profile, and Diabetes Health Promotion Scale
Measured: Pre-test (baseline)
Diabetes health promotion scale
A self-report study instrument that includes the health profile, and Diabetes Health Promotion Scale
Measured: 1 months after intervnetion
Diabetes health promotion scale
A self-report study instrument that includes the health profile, and Diabetes Health Promotion Scale
Measured: 3 months after intervnetion
Hemoglobin A1C (HbA1c) Test
An HbA1c test shows what the average amount of glucose attached to hemoglobin has been over the past three months.
Measured: 3 months after intervnetion
Hemoglobin A1C (HbA1c) Test
An HbA1c test shows what the average amount of glucose attached to hemoglobin has been over the past three months
Measured: Pre-test (baseline)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2026
- Study start12 May 2020
- Primary completion30 Oct 2020
- Study completion30 Jun 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes Mellitus, Type 2Studies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fooyin University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07810647
- Sponsor's protocol ID
- FooyinU
- Acronym
- SDM
- Status last verified
- Sep 2021
- First submitted
- 14 Mar 2022
- Last updated
- 9 Sep 2026
- Results posted
- No
- Data monitoring committee
- 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 9 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Shared Decision Making（SDM）on Patients With Poor Control Type 2 Diabetes
- ClinicalTrials.gov ID
- NCT07810647
- Acronym / sponsor ID
- SDM / FooyinU
- Conditions
- Diabetes Mellitus, Type 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Fooyin UniversityUniversity, hospital or other
- Study start
- 12 May 2020 (actual)
- Primary completion
- 30 Oct 2020 (actual)
- Study completion
- 30 Jun 2021 (actual)
- First posted
- 9 Sep 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.
The study is a pilot study, using a convenient sampling method, targeting at outpatient patients with type 2 diabetes who participate in the diabetes co-care program and poor blood sugar control as the research subjects, and randomly assigned. The number of samples is expected to receive 30 patients in each group. The attrition rate estimates about 20%, so there should be 76 people in total, and 38 people in each group. The experimental group was involved in SDM health education; the control group was involved in routine health education. After the implementation of the measures, the self-efficacy and health promotion behavior changes of the two groups and the effectiveness of disease control (glycated hemoglobin, body mass index, waist circumference) were tracked.
Detailed description
Background Diabetes and hyperglycemia not only increase the risk of complications of cardiovascular disease and lead to a situation involving exposure to danger of death. Meanwhile, the patient's self-management is one of the key factors affecting the quality control of blood sugar. Thereby, Shared Decision Making (SDM) is a patient-centered medical implementation method that healthcare professionals and patients jointly participate in treatment decision-making to reach a consensus, which can stimulate the health care ability of participants to achieve treatment goals.
Purpose： This research aims to implement the SDM model based on self-efficacy theory through individualized decision-making to strengthen the behavioral motivation of diabetic patients and finally, to improve the patient's health promotion behavior and the effectiveness of blood sugar control.
Method： Study Type: Interventional Actual Enrollment:76 participants Allocation:Randomized Intervention Model:Parallel Assignment Masking:Single(Participant)
Expected results:
It is hoped that the implementation of SDM model will be used to strengthen the behavioral motivation of diabetic patients through individualized decision-making, and to confirm whether it can effectively improve the patient's health behavior and the effectiveness of disease control.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control group:as usual care | No intervention | –The control group received as usual care. |
| Experimental group:The intervention of SDM | Experimental | Behavioral: SDMThe experimental group received the intervention of SDM 3 times for 3 months, |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Aged>20y/o
- Diagnosed by a physician as type 2 diabetes
- The Diabetes Participated in the Diabetes Shared Care Network
- Glycosylated hemoglobin (A1C)> 7.5%
- Can communicate in Chinese or Taiwanese.
Key exclusion criteria (2 listed)
- People with mental or cognitive impairment who cannot communicate
- Health Literacy score lower than 6 points
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 |
|---|---|---|
| SDMThe experimental group received the intervention of SDM 3times/month for 3months, then follow the health promotion behavior compliance by phone once a month. | Behavioural | Experimental group:The intervention of SDM |
Primary outcome
Diabetes self-efficacy scale
Time frame: Pre-test (baseline)
assesses the confidence of diabetes patients in their ability to manage their diet, blood sugar, and physical exercise
Diabetes self-efficacy scale
Time frame: 1 months after intervnetion
assesses the confidence of diabetes patients in their ability to manage their diet, blood sugar, and physical exercise
Diabetes self-efficacy scale
Time frame: 3 months after intervnetion
assesses the confidence of diabetes patients in their ability to manage their diet, blood sugar, and physical exercise
Diabetes health literacy scale
Time frame: Pre-test (baseline)
A disease-specific scale to measure functional, communicative and critical health literacy in primary care
Diabetes health literacy scale
Time frame: 3 months after intervnetion
A disease-specific scale to measure functional, communicative and critical health literacy in primary care
Diabetes health promotion scale
Time frame: Pre-test (baseline)
A self-report study instrument that includes the health profile, and Diabetes Health Promotion Scale
Diabetes health promotion scale
Time frame: 1 months after intervnetion
A self-report study instrument that includes the health profile, and Diabetes Health Promotion Scale
Diabetes health promotion scale
Time frame: 3 months after intervnetion
A self-report study instrument that includes the health profile, and Diabetes Health Promotion Scale
Hemoglobin A1C (HbA1c) Test
Time frame: 3 months after intervnetion
An HbA1c test shows what the average amount of glucose attached to hemoglobin has been over the past three months.
Hemoglobin A1C (HbA1c) Test
Time frame: Pre-test (baseline)
An HbA1c test shows what the average amount of glucose attached to hemoglobin has been over the past three 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 9 Sep 2026.
- 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. 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 SDM in people with Diabetes Mellitus, Type 2, run by Fooyin University 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 5 inclusion and 2 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 9 Sep 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 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?
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?
Diabetes self-efficacy scale (time frame: Pre-test (baseline)). The study lists 10 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 9 Sep 2026; AzTrials last refreshed its copy on 31 Oct 2026.