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Effectiveness of SCDM in Patients With Type 2 Diabetes (ESCDM)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04259489
Recruitment Status : Not yet recruiting
First Posted : February 6, 2020
Last Update Posted : February 6, 2020
Sponsor:
Information provided by (Responsible Party):
Guang Wang, Beijing Chao Yang Hospital

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.

Condition or disease Intervention/treatment Phase
Type 2 Diabetes Behavioral: Shared Care diabetes management Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 210 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: This is a prospective, randomization, parallel, controlled study.
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Effectiveness of Share Care Diabetes Management in Patients With Type 2 Diabetes
Estimated Study Start Date : January 31, 2020
Estimated Primary Completion Date : December 31, 2022
Estimated Study Completion Date : December 31, 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
No Intervention: Traditional therapy group
All patients in the control group will receive routine diabetes management, including lifestyle education, health guidance, blood glucose monitoring and medicine adjustment and other treatments which conducted by the endocrinology medical team. After the inclusion visit, the patients will be randomized to Shared Care group or traditional therapy group. Compared to conventional diabetes education in the traditional therapy group, the Shared Care group provides patients with online services and continuous diabetes management and education through a mobile application. It also addresses that it is important for patients to meet regularly with diabetes multidisciplinary team for better results. The total observation period is 3 years for each patient. The visits will be done every 3 months.
Active Comparator: Shared Care group
The Patients download the Shared Care mobile application and connect with the smart-glucometer BG1 to upload blood glucose dairy in real time. With patient's informed consent, his or her data from each visit will be collected and recorded for analysis. After the patient returns home from the clinic, they can communicate through the APP with online diabetes educators. According to protocol, online diabetes educators answer patients' questions, give suggestions on patients' diet and summarize patients' issues to physicians, who provide high level supervision.
Behavioral: Shared Care diabetes management
After the inclusion visit, the patients will be randomized to Shared Care group or traditional therapy group. Compared to conventional diabetes education in the traditional therapy group, the Shared Care group provides patients with online services and continuous diabetes management and education through a mobile application. It also addresses that it is important for patients to meet regularly with diabetes multidisciplinary team for better results. The total observation period is 3 years for each patient. The visits will be done every 3 months.




Primary Outcome Measures :
  1. Glycemic achieving rate [ Time Frame: through study completion, 1 year follow-up ]
    Glycemic achieving rate with HbA1c<7% at 1-year follow-up


Secondary Outcome Measures :
  1. HbA1c change [ Time Frame: through study completion, 1 year follow-up ]
    Changes in HbA1c from baseline at 3, 6, and 12 months during follow-up

  2. Blood pressure change and rate of reaching the standard [ Time Frame: through study completion, 1 year follow-up ]
    Changes in blood pressure and the rate of reaching the standard (< 130/80) , including systolic blood pressure less than 130mmHg and diastolic blood pressure less than 80mmHg compared with the baseline at 3, 6, and 12 months respectively during follow-up.

  3. LDL-c changes and rate of reaching the standard [ Time Frame: through study completion, 1 year follow-up ]
    The changes of low density lipoprotein (LDL-c) compared with the baseline and the rate of reaching the standard (less than 2.6 mmol/L) at 3, 6, and 12 months during follow-up.

  4. BMI change and rate of reaching the standard [ Time Frame: through study completion, 1 year follow-up ]
    The changes of BMI from baseline and the rate of reaching the standard at 3, 6, and 12 months during follow-up. BMI is body mass index, weight and height will be combined to report BMI in kg/m^2

  5. Medicine expenditure change [ Time Frame: through study completion, 1 year follow-up ]
    Patients' daily medicine expenditure (rmb / day) changed from baseline at 3, 6, and 12 months during follow-up

  6. SDSCA(Summary of Diabetes Self Care Activities) score change [ Time Frame: through study completion, 1 year follow-up ]
    The change between baseline SDSCA score and SDSCA score 1 years after admission, SDSCA is scale Summary of Diabetes Self Care Activities (SDSCA), with 12 questions, each provide a minimum of 0 and maximum of 7 scores (7 indicates better self care action), total score 84.

  7. C-DMSES(Chinese Diabetes Management Self-Efficacy Scale) score change [ Time Frame: through study completion, 1 year follow-up ]
    The change between baseline C-DMSES and C-DMSES 1 years after admission. C-DMSES is Chinese Diabetes Management Self-Efficacy Scale. The scale measures the self-efficacy level of diabetes management. The C-DMSES has 20 questions, each question has a minimum score of 0 (indicates lowest self-efficacy), maximum score of 10(indicates highest self-efficacy). the scale has totally 200 scores.

  8. A-DQOL(Amendment Diabetes Quality of Life scale) score change [ Time Frame: through study completion, 1 year follow-up ]
    The change between baseline A-DQOL score and A-DQOL score 1 years after admission. CA-DQOL has maximum score of 230. Subscale 1 measures life satisfaction and has 15 questions, each question has a minimum score of 1 (indicates very unsatisfied), maximum score of 5(indicates very satisfied). Subscale 2 measures frequency of diabetes affects life quality, has 20 questions, each question has a minimum score of 1 (indicates never affect life quality), maximum score of 5(indicates always affect life quality). Subscale 3 measures how much the patient worries about how diabetes affects daily life and has 7 questions, each question has a minimum score of 1 (indicates never worries), maximum score of 5(indicates very worries). Subscale 4 measures how much the patient worries about the diabetes-related conditions and has 4 questions, each question has a minimum score of 1 (indicates never worries), maximum score of 5(indicates very worries).

  9. Morisky scale score change [ Time Frame: through study completion, 1 year follow-up ]
    The change between baseline Morisky score and Morisky score 1 years after admission. Morisky scale measures patients' compliance of medication usage. The Morisky scale has 4 questions, each question has a minimum score of 0 (did not comply the medical instruction), maximum score of 1(comply medical instruction). the scale has totally 4 scores.

  10. DASS-C21 scale score change [ Time Frame: through study completion, 1 year follow-up ]
    The change between baseline DASS-C21 scale score and DASS-C21 scale score 1 years after admission. DASS-C21 scale is Depression Anxiety Stress Scale 21 scale in Chinese. The scale measures patients' level of depression, anxiety and stress. The scale has 21 questions, each question has a minimum score of 0 (did not meet the description), maximum score of 3(completely meet the description). the scale has totally 63 scores.

  11. Number of newly diagnosed diabetic complications [ Time Frame: through study completion, 1 year follow-up ]
    During the follow-up period, number of newly diagnosed diabetic complications, including diabetic nephropathy, diabetic retinopathy, diabetic neuropathy and diabetic podiatry, etc.

  12. The progress of diabetic complications [ Time Frame: through study completion, 1 year follow-up ]
    During the follow-up period, the progress of diabetic complications such as diabetic nephropathy, diabetic retinopathy, diabetic neuropathy and diabetic foot disease

  13. The times of Emergency visits due to hyperglycemia [ Time Frame: through study completion, 1 year follow-up ]
    During the follow-up period, the times of Emergency visits due to hyperglycemia were collected during each follow-up.

  14. The times of Emergency visits due to hypoglycemia [ Time Frame: through study completion, 1 year follow-up ]
    During the follow-up period, the times of Emergency visits due to hypoglycemia were collected during each follow-up.

  15. The times of Hospitalization due to hyperglycemia [ Time Frame: through study completion, 1 year follow-up ]
    During the follow-up period, the times of hospitalization due to hyperglycemia were collected during each follow-up.

  16. The times of Hospitalization due to hypoglycemia [ Time Frame: through study completion, 1 year follow-up ]
    During the follow-up period, the times of hospitalization due to hypoglycemia were collected during each follow-up.

  17. The days of Hospitalization due to hyperglycemia [ Time Frame: through study completion, 1 year follow-up ]
    During the follow-up period, the days of hospitalization due to hyperglycemia were collected during each follow-up.

  18. The days of Hospitalization due to hypoglycemia [ Time Frame: through study completion, 1 year follow-up ]
    During the follow-up period, the days of hospitalization due to hypoglycemia were collected during each follow-up.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04259489


Contacts
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Contact: Jia Liu, MD 861085231710 liujia0116@126.com

Locations
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China, Beijing
Beijing Chao-Yang Hospital, Capital Medical University
Beijing, Beijing, China
Sponsors and Collaborators
Beijing Chao Yang Hospital

Publications:
International Diabetes Federation. IDF Diabetes Atlas. Brussels, Belgium: International Diabetes Federation 8th edition; 2017

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Responsible Party: Guang Wang, Professor and Director, Department of Endocrinology, Beijing Chao Yang Hospital
ClinicalTrials.gov Identifier: NCT04259489    
Other Study ID Numbers: 2020-T2DM
First Posted: February 6, 2020    Key Record Dates
Last Update Posted: February 6, 2020
Last Verified: February 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Guang Wang, Beijing Chao Yang Hospital:
Type 2 Diabetes
Diabetes Education and Management
Share Care
Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases