Clinical trial NCT05556161: Effects of the General Practitioners and Diabetes Specialists Co-management Model for Patients With Type 2 Diabetes
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Type2diabetes
Lead sponsor: Huazhong University of Science and Technology
Sponsor class: OTHER
Collaborators: name: Baoan Central Hospital of Shenzhen
First posted: 2022-09-27
Enrollment: 609
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: TREATMENT

Brief 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. 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.

Eligibility criteria: Inclusion Criteria:

1. Diagnosed with type 2 diabetes for over 1 year according to the diagnostic criteria of diabetes formulated by the World Health Organization;
2. Male or female residents aged 18-85 years;
3. HbA1c measured within 6 months before enrollment was 7.0%-10.0%;
4. Lived in the catchment and have established health records for at least 6 months, and have no plans to move out at present;
5. patients used smartphones;
6. Sign the informed consent and participate in the study voluntarily.

Exclusion Criteria:

1. Patients used insulin within 1year before enrollment;
2. 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;
3. Patients used continuous glucose monitoring (CGM) in the past 3 months;
4. 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).
5. 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;
6. Patients with cognitive impairment, or patients unable to use mobile phones to answer calls.

Primary outcomes:
measure: HbA1c change
timeFrame: Baseline, 6, and 18 months
Secondary outcomes:
measure: Fasting Plasma Glucose
timeFrame: Baseline, 6, and 18 months
measure: Total cholesterol
timeFrame: Baseline, 6, and 18 months
measure: Triglycerides
timeFrame: Baseline, 6, and 18 months
measure: LDL-C
timeFrame: Baseline, 6, and 18 months
measure: HDL-C
timeFrame: Baseline, 6, and 18 months
measure: Blood pressure
timeFrame: Baseline, 6, and 18 months
measure: Body Mass Index (BMI)
timeFrame: Baseline, 6, and 18 months
measure: Diabetes self-care activities
timeFrame: Baseline, 6, and 18 months
measure: Diabetes distress
timeFrame: Baseline, 6, and 18 months
measure: Depressive symptoms
timeFrame: Baseline, 6, and 18 months
measure: Self-Efficacy
timeFrame: Baseline, 6, and 18 months
Other outcomes:
Locations:
city: Shenzhen
country: China
facility: Baoan Central Hospital of Shenzhen
state: Guangdong
Study officials:
affiliation: Huazhong University of Science and Technology
name: Xiaoxv Yin
role: STUDY_DIRECTOR
References: