Type2diabetesNCT05556161
Effects of the General Practitioners and Diabetes Specialists Co-management Model for Patients With Type 2 Diabetes
A study testing General Practitioners and Diabetes Specialists Co-management in people with Type2diabetes, run by Huazhong University of Science and Technology at 1 site in China.
Trial summary
This is a prospective, randomized, parallel, multicenter controlled study to evaluate the effectiveness of the general practitioners and diabetes specialists co-management model for type 2 diabetes. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Type2diabetes
- What is being tested?
- General Practitioners and Diabetes Specialists Co-management
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 609 participants
- Where
- 1 siteChina
- Study dates
- 1 Oct 2021to 30 Jun 2023
- 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 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosed with type 2 diabetes for over 1 year according to the diagnostic criteria of diabetes formulated by the World Health Organization;
- Male or female residents aged 18-85 years;
- HbA1c measured within 6 months before enrollment was 7.0%-10.0%;
- Lived in the catchment and have established health records for at least 6 months, and have no plans to move out at present;
- patients used smartphones;
- Sign the informed consent and participate in the study voluntarily.
Who cannot join
- Patients used insulin within 1year before enrollment;
- patients with type 1 diabetes, Latent autoimmune diabetes of adults(LADA), gestational diabetes, patients with extremely poor islet function (fasting C-peptide < 0.1ng/ml) and patients with special type of diabetes;
- Patients used continuous glucose monitoring (CGM) in the past 3 months;
- Patients with serious complications (such as Stage G5 of diabetic nephropathy, severe loss of vision or blindness due to diabetic retinopathy and patients without self-care ability due to diabetic foot amputation).
- Patients who suffered from serious mental illness or late stage of other serious diseases (such as malignant tumors, acute cardiovascular disease (like stroke, myocardial infarction), serious liver insufficiency, patients with history of diabetic ketoacidosis, patients with alcohol or drug abuse or dependence and patients with a history of cardiac surgery in the last 3 months;
- Patients with cognitive impairment, or patients unable to use mobile phones to answer calls.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of the General Practitioners and Diabetes Specialists Co-management Model for Patients With Type 2 Diabetes in the Community: a Randomized Controlled Trial
This is a prospective, randomized, parallel, multicenter controlled study to evaluate the effectiveness of the general practitioners and diabetes specialists co-management model for type 2 diabetes. Patients with type 2 diabetes will be randomized to participate in the community general practitioners and diabetes specialists management or serve as controls continuing with routine primary health care. The primary outcome is to observe the HbA1c change.
Read the detailed description
Aim: This study constructs a general practitioner and diabetes specialist co-management model for patients with type 2 diabetes in the community based on the integration of prevention and treatment strategies. Also, the effectiveness of the model will be evaluated by a parallel randomized controlled trial design to provide theoretical support and empirical evidence for the development of a comprehensive management strategy for patients with type 2 diabetes.
Hypothesis: Compared to the control group, the intervention group receiving co-management by general practitioners and diabetes specialists has a greater improvement in HbA1c, fasting glucose, blood pressure, lipids, BMI, diabetes self-management ability, depression symptoms, diabetes distress, and diabetes complications-related indicators.
Recruiting: This study will recruit patients with type 2 diabetes who have established electronic health records in 5 community healthcare centers affiliated with the Baoan Central Hospital of Shenzhen. General practitioners at the community healthcare centers screen patients with type 2 diabetes under their care who are eligible for the study based on the inclusion and exclusion criteria. Following face-to-face communication, general practitioners explain the study objectives and procedures to patients and obtain their informed consent.
Before the start of the study, unified training will be conducted for the general practitioners involved in the recruitment so that they can clarify the inclusion and exclusion criteria, screening methods, and precautions regarding the study objects.
Randomization Procedure: Members of the research team served as the grouping scheme controllers of the randomization center. The Proc plan procedure of SAS 9.4 statistical software was used to generate random number sequences and grouping schemes according to a 1:1 assignment. For the patients with type 2 diabetes who met the inclusion and exclusion criteria, general practitioners contacted randomization center staff members by telephone according to the patients' order of arrival at the community healthcare center and informed them of the patient's name and ID number. Then the randomization center staff recorded patient information, numbered the patients, and divided them into an intervention group or control group according to the previously generated random number table. Finally, the randomization center staff informed patients' general practitioners of their grouping results.
Study design: The study includes three phases: baseline, intervention, and follow-up. All participants will be divided into an intervention group and a control group after completing the baseline survey. The implementation phase of the intervention will last 18 months. Patients in the intervention group will have daily blood glucose monitoring with a smart home blood glucose meter. Each patient will be assigned a dedicated general practitioner to track the patient's blood glucose monitoring results. Based on the remote monitoring of blood glucose and HbA1c tests, general practitioners and specialists will jointly carry out management measures including health education, medication adjustment, outpatient consultation, referral, and case discussion for participants.
The control group will be routinely treated and followed up by general practitioners according to Chinese clinical guidelines and national norms for basic public health services.
Data collection and management: baseline and follow-up data were collected using questionnaires and physical examination record forms. The collected data was entered into Epidata software and imported into Statistical Analysis System (SAS) 9.4 for analysis. After the end of the experiment, the data will be stored in the database of our research group for a long time.
- Conditions
- Type2diabetes
- Being tested
- General Practitioners and Diabetes Specialists Co-management
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
General Practitioners and Diabetes Specialists Co-managementBehavioural
Self-monitoring of blood glucose: Participants will monitor blood glucose with a a free intelligent home blood glucose meter. Then, the intelligent blood glucose meter will upload data to the platform.
Glycosylated hemoglobin check:
Cooperative General Practitioner-Specialist Management: Based on the remote monitoring of blood glucose, general practitioners and specialists will jointly carry out management measures including health education, medication adjustment, outpatient consultation, referral, case discussion, etc. for participants.
| Study group | Role | What they receive |
|---|---|---|
| Intervention Group | Experimental | The 12-month general practitioners and diabetes specialists co-management will be received by intervention group participants. Receives: Behavioral: General Practitioners and Diabetes Specialists Co-management |
| Control group | No intervention | Routine primary health care will be received by control group participants during the course of the Study. |
What is being measured
The primary outcome is the main question the study is designed to answer.
HbA1c change
The change of HbA1c during the study. The level of HbA1c in blood measured in %.
Measured: Baseline, 6, and 18 months
Secondary outcomes (11)
Fasting Plasma Glucose
The change of HbA1c during the study.
Measured: Baseline, 6, and 18 months
Total cholesterol
The change of total cholesterol during the study.
Measured: Baseline, 6, and 18 months
Triglycerides
The change of total triglycerides during the study.
Measured: Baseline, 6, and 18 months
LDL-C
The change of LDL-C during the study.
Measured: Baseline, 6, and 18 months
HDL-C
The change of LDL-C during the study.
Measured: Baseline, 6, and 18 months
Blood pressure
The change of blood pressure during the study.
Measured: Baseline, 6, and 18 months
Body Mass Index (BMI)
The change of BMI during the study.
Measured: Baseline, 6, and 18 months
Diabetes self-care activities
Diabetes self-care activities will be measured by the Summary of Diabetes Self-Care Activities (SDSCA) scale. The SDSCA scale measures the frequency of performing diabetes self-care activities, including diet, exercise, blood glucose testing, foot care, and tobacco use over the past 7 days. SDSCA comprises of 11 items and each item's response is rated on 7 point scale ranging from '0' to '7' . A higher score would be the frequency of performing self-care activities.
Measured: Baseline, 6, and 18 months
Diabetes distress
Diabetes distress scores will be measured by the Problem Areas In Diabetes (PAID). The scale ranges from a minimum of 0 (not a problem) to a maximum score of 4 (serious problem). The sum of the five questions provides the participant's score with a score range of minimum score of 0 to a maximum score of 20. A total score of greater than or equal to 8 indicates possible diabetes related emotional distress, with a higher score indicating more significant distress.
Measured: Baseline, 6, and 18 months
Depressive symptoms
Depressive symptoms will be assessed by the Patient Health Questionnaire (PHQ-9). The PHQ-9 is a 9-item scale where respondents indicate how much they are bothered by certain problems on a 4-point scale where 0 = not at all and 3 = nearly every day. Total scores range from 0 to 27 with degree of depression considered minimal for scores between 0-4, mild for scores of 5-9, moderate for scores of 10-14, moderate to severe for scores 15-19, and severe for scores of 20-27.
Measured: Baseline, 6, and 18 months
Self-Efficacy
Participants' self-efficacy level will be measured by the Diabetes Empowerment Scale (DES-SF). The scale consists of 10 items and reports in a 5-points Likert scale. An item checked "strongly agree" receives 5 points; "agree" - 4 points; "neutral" - 3 points; "disagree" - 2 points; and "strongly disagree" receives 1 points. Minimum score is 8, max is 40. Higher scores indicate greater sense of empowerment to self-manage condition.
Measured: Baseline, 6, and 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Sep 2022
- Study start1 Oct 2021
- Primary completion30 May 2023
- Study completion30 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type2diabetesStudies of the same condition, open and under way.
- More trials run by Huazhong University of Science and TechnologyThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- In parallel arm design, subjects are randomized to one or more study arms and each study arm will be allocated a different intervention. After randomization each subject stays in their assigned treatment arm for the duration of the study. Subjects receive the same treatment throughout the trial. The results are then compared.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 609 participants (actual)
Sponsor and investigators
- Lead sponsor
- Huazhong University of Science and Technology
- Sponsor type
- University, hospital or other
- Collaborators
- Baoan Central Hospital of Shenzhen
- Responsible party
- Principal investigator, Xiaoxv Yin, PhD, Huazhong University of Science and Technology
- Investigators
- Xiaoxv Yin, Study director, Huazhong University of Science and Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05556161
- Sponsor's protocol ID
- GPDSCM-T2DM
- Status last verified
- Jun 2023
- First submitted
- 22 Sep 2022
- Last updated
- 30 Apr 2025
- 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 30 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of the General Practitioners and Diabetes Specialists Co-management Model for Patients With Type 2 Diabetes in the Community: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05556161
- Acronym / sponsor ID
- GPDSCM-T2DM
- Conditions
- Type2diabetes
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 609 participants (actual)
- Lead sponsor
- Huazhong University of Science and TechnologyUniversity, hospital or other
- Collaborators
- Baoan Central Hospital of Shenzhen
- Study start
- 1 Oct 2021 (actual)
- Primary completion
- 30 May 2023 (actual)
- Study completion
- 30 Jun 2023 (actual)
- First posted
- 27 Sep 2022 (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 is a prospective, randomized, parallel, multicenter controlled study to evaluate the effectiveness of the general practitioners and diabetes specialists co-management model for type 2 diabetes. Patients with type 2 diabetes will be randomized to participate in the community general practitioners and diabetes specialists management or serve as controls continuing with routine primary health care. The primary outcome is to observe the HbA1c change.
Detailed description
Aim: This study constructs a general practitioner and diabetes specialist co-management model for patients with type 2 diabetes in the community based on the integration of prevention and treatment strategies. Also, the effectiveness of the model will be evaluated by a parallel randomized controlled trial design to provide theoretical support and empirical evidence for the development of a comprehensive management strategy for patients with type 2 diabetes.
Hypothesis: Compared to the control group, the intervention group receiving co-management by general practitioners and diabetes specialists has a greater improvement in HbA1c, fasting glucose, blood pressure, lipids, BMI, diabetes self-management ability, depression symptoms, diabetes distress, and diabetes complications-related indicators.
Recruiting: This study will recruit patients with type 2 diabetes who have established electronic health records in 5 community healthcare centers affiliated with the Baoan Central Hospital of Shenzhen. General practitioners at the community healthcare centers screen patients with type 2 diabetes under their care who are eligible for the study based on the inclusion and exclusion criteria. Following face-to-face communication, general practitioners explain the study objectives and procedures to patients and obtain their informed consent.
Before the start of the study, unified training will be conducted for the general practitioners involved in the recruitment so that they can clarify the inclusion and exclusion criteria, screening methods, and precautions regarding the study objects.
Randomization Procedure: Members of the research team served as the grouping scheme controllers of the randomization center. The Proc plan procedure of SAS 9.4 statistical software was used to generate random number sequences and grouping schemes according to a 1:1 assignment. For the patients with type 2 diabetes who met the inclusion and exclusion criteria, general practitioners contacted randomization center staff members by telephone according to the patients' order of arrival at the community healthcare center and informed them of the patient's name and ID number. Then the randomization center staff recorded patient information, numbered the patients, and divided them into an intervention group or control group according to the previously generated random number table. Finally, the randomization center staff informed patients' general practitioners of their grouping results.
Study design: The study includes three phases: baseline, intervention, and follow-up. All participants will be divided into an intervention group and a control group after completing the baseline survey. The implementation phase of the intervention will last 18 months. Patients in the intervention group will have daily blood glucose monitoring with a smart home blood glucose meter. Each patient will be assigned a dedicated general practitioner to track the patient's blood glucose monitoring results. Based on the remote monitoring of blood glucose and HbA1c tests, general practitioners and specialists will jointly carry out management measures including health education, medication adjustment, outpatient consultation, referral, and case discussion for participants.
The control group will be routinely treated and followed up by general practitioners according to Chinese clinical guidelines and national norms for basic public health services.
Data collection and management: baseline and follow-up data were collected using questionnaires and physical examination record forms. The collected data was entered into Epidata software and imported into Statistical Analysis System (SAS) 9.4 for analysis. After the end of the experiment, the data will be stored in the database of our research group for a long time.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- In parallel arm design, subjects are randomized to one or more study arms and each study arm will be allocated a different intervention. After randomization each subject stays in their assigned treatment arm for the duration of the study. Subjects receive the same treatment throughout the trial. The results are then compared.
| Arm | Type | Receives |
|---|---|---|
| Intervention Group | Experimental | Behavioral: General Practitioners and Diabetes Specialists Co-managementThe 12-month general practitioners and diabetes specialists co-management will be received by intervention group participants. |
| Control group | No intervention | –Routine primary health care will be received by control group participants during the course of the Study. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Diagnosed with type 2 diabetes for over 1 year according to the diagnostic criteria of diabetes formulated by the World Health Organization;
- Male or female residents aged 18-85 years;
- HbA1c measured within 6 months before enrollment was 7.0%-10.0%;
- Lived in the catchment and have established health records for at least 6 months, and have no plans to move out at present;
- patients used smartphones;
Key exclusion criteria (6 listed)
- Patients used insulin within 1year before enrollment;
- patients with type 1 diabetes, Latent autoimmune diabetes of adults(LADA), gestational diabetes, patients with extremely poor islet function (fasting C-peptide < 0.1ng/ml) and patients with special type of diabetes;
- Patients used continuous glucose monitoring (CGM) in the past 3 months;
- Patients with serious complications (such as Stage G5 of diabetic nephropathy, severe loss of vision or blindness due to diabetic retinopathy and patients without self-care ability due to diabetic foot amputation).
- Patients who suffered from serious mental illness or late stage of other serious diseases (such as malignant tumors, acute cardiovascular disease (like stroke, myocardial infarction), serious liver insufficiency, patients with history of diabetic ketoacidosis, patients with alcohol or drug abuse or dependence and patients with a history of cardiac surgery in the last 3 months;
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 |
|---|---|---|
| General Practitioners and Diabetes Specialists Co-managementSelf-monitoring of blood glucose: Participants will monitor blood glucose with a a free intelligent home blood glucose meter. Then, the intelligent blood glucose meter will upload data to the platform. Glycosylated hemoglobin check: Cooperative General Practitioner-Specialist Management: Based on the remote monitoring of blood glucose, general practitioners and specialists will jointly carry out management measures including health education, medication adjustment, outpatient consultation, referral, case discussion, etc. for participants. | Behavioural | Intervention Group |
Primary outcome
HbA1c change
Time frame: Baseline, 6, and 18 months
The change of HbA1c during the study. The level of HbA1c in blood measured in %.
11 secondary outcomes
Fasting Plasma Glucose
Time frame: Baseline, 6, and 18 months
Total cholesterol
Time frame: Baseline, 6, and 18 months
Triglycerides
Time frame: Baseline, 6, and 18 months
LDL-C
Time frame: Baseline, 6, and 18 months
HDL-C
Time frame: Baseline, 6, and 18 months
Blood pressure
Time frame: Baseline, 6, and 18 months
Body Mass Index (BMI)
Time frame: Baseline, 6, and 18 months
Diabetes self-care activities
Time frame: Baseline, 6, and 18 months
Diabetes distress
Time frame: Baseline, 6, and 18 months
Depressive symptoms
Time frame: Baseline, 6, and 18 months
Self-Efficacy
Time frame: Baseline, 6, and 18 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 30 Apr 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. This study is not recruiting at the moment.
Xiaoxv Yin study director
Huazhong University of Science and Technology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing General Practitioners and Diabetes Specialists Co-management in people with Type2diabetes, run by Huazhong University of Science and Technology at 1 site in China.
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 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: finished, as of the sponsor's last update on 30 Apr 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 China. 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?
HbA1c change (time frame: Baseline, 6, and 18 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 30 Apr 2025.