Clinical trial NCT04259489: Effectiveness of SCDM in Patients With Type 2 Diabetes
Official title: Effectiveness of Share Care Diabetes Management in Patients With Type 2 Diabetes
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Type 2 Diabetes
Keywords: Type 2 Diabetes
Diabetes Education and Management
Share Care
Lead sponsor: Beijing Chao Yang Hospital
Sponsor class: OTHER
First posted: 2020-02-06
Enrollment: 210
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This is a prospective, randomization, parallel, controlled study.
Primary purpose: SUPPORTIVE_CARE

Brief summary: This is a prospective, randomization, parallel, controlled study, which conducted to evaluate the effectiveness and related influencing factors of the Shared Care multidisciplinary diabetes care model. Patients with T2DM involved in the Shared Care model pay regularly quarterly visit to a multidisciplinary team led by physician at outpatient clinic, and receive remote and systematic management and education online after going home. After at least one year follow-up, evaluate the glycemic achieving rate (HbA1c\<7%), the diabetes self-management behavior change and the effect of online diabetes self-management support for patients of the Shared Care multidisciplinary diabetes care model.

Detailed description: Diabetes is a complex, chronic illness requiring continuous medical care with multifactorial risk-reduction strategies beyond glycemic control. At present, about 114 million diabetics and 11.6% incidence rate of diabetes in China have produced huge chronic disease management pressure and created great challenges for China's limited medical resources. (1-5). Meanwhile, with population aging and increasing prevalence of obesity in China, the number of patients with diabetes mellitus, diabetes-related complications and related mortality are expected to further increase, which also indicates greater healthcare expenditure and socioeconomic burden. A multi-center, cross-sectional survey of outpatients conducted in 606 hospitals across China showed that the majority of patients with type 2 diabetes did not achieve the goal of HbA1c \<7.0% (6). There are varieties of problems including inadequate patient education, inability to track the out-of-hospital situation of diabetes, and lack of effective patient follow-up and education between each visits (1-5). Many researches have proved that comprehensive diabetes management education can significantly improve the quality of life of patients, decrease the incidence and mortality of diabetes complications, and relieve the government's medical economic burden (7). Besides, A number of studies have shown that the early detection and comprehensive management of diabetes can prevent the occurrence of a variety of complications and decrease the disability rate and premature death rate of diabetes. Therefore, how to improve the current situation of diabetes control in China is very important and a real problem in front of every doctor, patient and health institution. According to the diabetes management guidelines published by American Diabetes Association(ADA) and the National Institutes of Health(NIH), continuous follow-up of patients, diabetes self-management education and support (DSME/S) combined with multidisciplinary team comprehensive management can be abled to achieve better management results, and it is also a more comprehensive and cost-effective way to manage diabetic patients (8-12). In order to support health professionals to improve medical efficiency and promote patients develop healthy lifestyle, Shared Care diabetes management model established and believe that it will provide a sustained and effective solution for improving the effectiveness of comprehensive management for patients and reducing the burden of national chronic disease management.

The Shared Care aims to provide patients with a continuous management model of omni-directional and lifelong care management, and to strengthen diabetes self-management education and supports (DSME/S), achieve better health outcomes and delay incidence and mortality of diabetic complications. The model consisted of a medical team that includes dietitians, diabetes educators, nurses and physical therapist led by physician, and provides comprehensive disease and health management for patients with diabetes through outpatient consultation and out-of-hospital online continuous management. The management strategy is adjusted and individualized based on patients' habit and situation. Compared with traditional diabetes outpatient settings, patients of Shared Care return to the hospital for regular follow-up every three months since the initial visit after the informed consent. For each follow-up, a comprehensive management plan is made by a multidisciplinary team, including doctor consultation, diabetes management, foot evaluation, fundus assessment, insulin injection assessment, exercise evaluation and guidance, etc. The patients download the Shared Care mobile application during the outpatient service and connect with the smart-glucometer BG1 to upload blood glucose dairy, blood pressure diary and food log in real time.

With patient's informed consent, Patient-related vital signs (such as height, weight, body mass index, blood pressure, waist, hips), laboratory indicators (including glycated hemoglobin, low-density lipoprotein, total cholesterol, triglycerides, kidney indicators such as urine microalbumin and creatinine Ratio, glomerular filtration rate), blood glucose records, online learning frequency and other data will be uniformly recorded and comprehensively analyzed.

All out-of-hospital online diabetes educators are qualified as registered nurses. Before the start of the study, the nurses should uniformly receive training and examination related to diabetes education in the Department of Endocrinology of Chaoyang Hospital. The main contents of online education include personalized assessment and suggestions on diet, hyperglycemia and hypoglycemia events, drug use and insulin preservation as directed by doctors, and on blood glucose monitoring and reminders for revisit every three months, etc. In case of special circumstances or prescription adjustment, online diabetes educators should follow the training process to summarize the patient's condition with the doctor on the same day or during the weekly regular outpatient clinic, or arrange additional subsequent visit of the patient, all online consultation process is carried out under the supervision of the doctor (the diabetes educator spends about 5 minutes a week to discuss the condition of special patients with the doctor according to the actual situation). The model enables both patients and medical teams to carry out real-time data sharing, intelligent analysis and remote monitoring, thus significantly improving management efficiency and releasing medical resources.

A series of preliminary studies had been conducted in Chaoyang Hospital since January 2018. mean age of patients enrolled was 54.69 ± 11.14 years; the duration of diabetes was more than 7.8 ±7.0 years, and more than 70% were complicated with hypertension and / or dyslipidemia. The baseline glycemic achieving rate of patients with a duration more than 10 years was less than 35%. After participated in the Shared Care management model, glycemic achieving rate of patients with diabetic was more than 75%. Compared with the baseline HbA1c 7.4±1.5%, patients HbA1c in the latest follow-up was 6.6 ±1.0%, with the average decreased of 0.8 ±1.6% (P \<0.05). The 3B achieving rate (HbA1c \<7%, LDL-C \< 2.6mmol/L, BP \<130/80mmHg) of patients under the management of Shared Care Model was 21.84%. The baseline urinary microalbuminuria / creatinine (UACR) 35.8mg/g was not significantly increased compared with the last follow-up of 32.1mg/g (P\>0.10). The daily cost of hypoglycemic medicine was significantly reduced in patients with the duration of diabetes less than 2 years or 15 years or more (medicine daily cost of the baseline and the latest follow-up was 3.5 RMB per day and 2.3 RMB per day respectively in patients with the duration of diabetes less than 2 years (P\<0.05); medicine daily cost of the baseline and the latest follow-up was 10.4 RMB per day and 9.5 RMB per day respectively in patients with the duration of diabetes of 15 years or more (P\<0.05)), but there was no significant increase in patients with other durations of diabetes.

The study evaluated and explored the effect of patient management and related factors under the Share Care management model aims to provide a clear evidence for the choice of new diagnosis and treatment strategies for patients with diabetes.

All patients enrolled in the study need to go through screening, initial visit, revisit, half-year visit and annual visit. The following is an overview of the research design.

Screening:

210 patients with type 2 diabetes who met the criteria were enrolled. All patients with informed consent will undergo basic interviews, vital sign measurements and related biochemical tests. During the screening phase, the following variables will be collected: age, sex, smoking status (current smokers, former smokers, non-smokers), duration of diabetes, duration of dyslipidemia, concomitant diseases and medication, etc. Besides, vital signs, 12-lead electrocardiogram, regular blood test and glycated hemoglobin (HbA1c), the patient's blood lipid spectrum includes total cholesterol (TC), triglyceride (TG), High density lipoprotein cholesterol (HDL-C) and low density lipoprotein cholesterol (LDL-C), albumin-to-creatinine ratio(ACR) and safety laboratory measurements (creatine kinase, SCr, BUN, UA, ALT, AST) also will be collected. The designated researcher will conduct a serum pregnancy test on all fertile women. The body mass index ((BMI)) is calculated by dividing weight by the square of height (kg / m2). After fasting overnight for 8 to 12 hours, the blood samples were collected before breakfast the next day. EGFR will be calculated using a Modification of diet in renal disease (MDRD).

Initial visit:

* Check the inclusion / exclusion criteria to confirm whether subjects are eligible to participate in the study. After confirming, the subjects will be randomly divided into the shared care group or the traditional therapy group according to the random number table.
* Basic vital signs: including height, weight, waist, hips, blood pressure, etc.
* Collection of metabolic indicators: HbA1c, ACR, blood biochemistry, etc.
* The number and days of emergency visits or hospitalizations due to diabetes-related factors (diabetic ketoacidosis, diabetic hyperosmotic coma, severe hypoglycemia) in the past three months before joining the study
* Filling in and recording the related behavior scale (summary of diabetes self-care activities (SDSCA), chinese diabetes management self-efficacy scale(C-DMSES), adjusted diabetes-specific quality of life scale (A-DQOL), morisky drug compliance scale and depression-anxiety-stress scale (DASS-21)).
* Insulin evaluation (including rotation of patients' insulin injection site, each change of needle, skin condition, preservation of insulin and correct use of insulin pen, etc.)
* Fundus evaluation.
* Foot evaluation.
* Health education.
* Daily medicine cost of patients

Revisit (every three months):

* Basic vital signs: including height, weight, waist, hips, blood pressure, etc.
* Collection of metabolic indicators: HbA1c, ACR, blood biochemistry, etc.
* The number and days of emergency visits or hospitalizations in the last three months (or since the last visit) due to diabetes-related factors (diabetic ketoacidosis, diabetic hyperosmotic coma, severe hypoglycemia)
* Daily medicine cost of patients half-year visit (every 6 months from the initial visit) needs to be added on the basis of the index of revisit.
* Basic vital signs: including height, weight, waist, hips, blood pressure, etc.
* Collection of metabolic indicators: HbA1c, ACR, blood biochemistry, etc.
* The number and days of emergency visits or hospitalizations in the last three months (or since the last visit) due to diabetes-related factors (diabetic ketoacidosis, diabetic hyperosmotic coma, severe hypoglycemia).
* Daily medicine cost of patients.
* Insulin evaluation.

Annual visit (every 12 months from the initial visit) in addition to all the indicators of revisit, there is also an increase:

* Filling in and recording the related behavior scale (summary of diabetes self-care activities (SDSCA), chinese diabetes management self-efficacy scale(C-DMSES), adjusted diabetes-specific quality of life scale (A-DQOL), morisky drug compliance scale and depression-anxiety-stress scale (DASS-21)).
* Insulin evaluation (including rotation of patients' insulin injection site, each change of needle, skin condition, preservation of insulin and correct use of insulin pen, etc.)
* Fundus evaluation.
* Foot evaluation.
* Insulin evaluation.

After being included in the study, patients were randomly divided into two groups: shared care group (experimental group) or traditional therapy group (control group). The total observation period for each patient was 1 year. Follow-up was carried out every 3 months. At each visit, the patient's basic condition, various vital signs and metabolic indicators, daily medicine cost of patients, and the number and days of emergency visits or hospitalizations in the last three months (or since the last visit) due to diabetes-related factors (diabetic ketoacidosis, diabetic hyperosmotic coma, severe hypoglycemia) will be collected.

Patients can download the Shared Care mobile application and connect with the smart-glucometer BG1 to upload blood glucose dairy in real time during the clinic. With patient's informed consent, the patient's follow-up data, laboratory indicators, etc. are uniformly collected and recorded for analysis.

Eligibility criteria: Inclusion Criteria:

* Patients 18-80 years old diagnosed with type 2 diabetes
* Patients who have Informed and signed the consent form content
* Patients can be regularly followed (every 3 months) for at least 1 years

Exclusion Criteria:

* Patients with important organ failure or other severe diseases including infection, mentally disorder, heart failure or disseminated intravascular coagulation
* Patients with active or inactive malignant tumour, expectation of life less than 1 year
* Patients with communication disorders, cannot communicate and/or cooperate
* Females that are regnant, breast-feeding female, or conception plan in the recent year

Primary outcomes:
measure: Glycemic achieving rate
timeFrame: through study completion, 1 year follow-up
Secondary outcomes:
measure: HbA1c change
timeFrame: through study completion, 1 year follow-up
measure: Blood pressure change and rate of reaching the standard
timeFrame: through study completion, 1 year follow-up
measure: LDL-c changes and rate of reaching the standard
timeFrame: through study completion, 1 year follow-up
measure: BMI change and rate of reaching the standard
timeFrame: through study completion, 1 year follow-up
measure: Medicine expenditure change
timeFrame: through study completion, 1 year follow-up
measure: SDSCA(Summary of Diabetes Self Care Activities) score change
timeFrame: through study completion, 1 year follow-up
measure: C-DMSES(Chinese Diabetes Management Self-Efficacy Scale) score change
timeFrame: through study completion, 1 year follow-up
measure: A-DQOL(Amendment Diabetes Quality of Life scale) score change
timeFrame: through study completion, 1 year follow-up
measure: Morisky scale score change
timeFrame: through study completion, 1 year follow-up
measure: DASS-C21 scale score change
timeFrame: through study completion, 1 year follow-up
measure: Number of newly diagnosed diabetic complications
timeFrame: through study completion, 1 year follow-up
measure: The progress of diabetic complications
timeFrame: through study completion, 1 year follow-up
measure: The times of Emergency visits due to hyperglycemia
timeFrame: through study completion, 1 year follow-up
measure: The times of Emergency visits due to hypoglycemia
timeFrame: through study completion, 1 year follow-up
measure: The times of Hospitalization due to hyperglycemia
timeFrame: through study completion, 1 year follow-up
measure: The times of Hospitalization due to hypoglycemia
timeFrame: through study completion, 1 year follow-up
measure: The days of Hospitalization due to hyperglycemia
timeFrame: through study completion, 1 year follow-up
measure: The days of Hospitalization due to hypoglycemia
timeFrame: through study completion, 1 year follow-up
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Chao-Yang Hospital, Capital Medical University
state: Beijing
Study officials:
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