NCT04100278

Brief Summary

This is a prospective, randomization, parallel, controlled study to evaluate the effectiveness of Shared Care diabetes management. 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 patient management and education after going home. After at least 3 years follow-up, patients' metabolic indexes including HbA1c, LDL-c, blood pressure, diabetes self-management behavior indexes and diabetes complications are evaluated. The primary goal is to observe the HbA1c levels and the HbA1c achieving rate. The secondary goal is to assess the diabetes self-management behavior change for patients of the Shared Care multidisciplinary diabetes care model and to assess the effect of online diabetes self-management support for patients of the Shared Care multidisciplinary diabetes care model.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
1,500

participants targeted

Target at P75+ for not_applicable type-2-diabetes-mellitus

Timeline
Completed

Started Jan 2020

Longer than P75 for not_applicable type-2-diabetes-mellitus

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 17, 2019

Completed
7 days until next milestone

First Posted

Study publicly available on registry

September 24, 2019

Completed
3 months until next milestone

Study Start

First participant enrolled

January 1, 2020

Completed
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2023

Completed
Last Updated

September 24, 2019

Status Verified

September 1, 2019

Enrollment Period

4 years

First QC Date

September 17, 2019

Last Update Submit

September 20, 2019

Conditions

Type 2 Diabetes Mellitus

Keywords

Type 2 DiabetesDiabetes Education and Management

Outcome Measures

Primary Outcomes (3)

  • HbA1c change

    The change between baseline HbA1c and HbA1c 3 years after admission

    through study completion, an average of 3 year

  • Blood Pressure change

    The change between baseline blood pressure and blood pressure 3 years after admission

    through study completion, an average of 3 year

  • LDL-c change

    The change between baseline LDL-c and LDL-c 3 years after admission

    through study completion, an average of 3 year

Secondary Outcomes (6)

  • BMI change

    through study completion, an average of 3 year

  • SDSCA(Summary of Diabetes Self Care Activities) score change

    through study completion, an average of 3 year

  • C-DMSES(Chinese Diabetes Management Self-Efficacy Scale) score change

    through study completion, an average of 3 year

  • A-DQOL(Amendment Diabetes Quality of Life scale) score change

    through study completion, an average of 3 year

  • Morisky scale score change

    through study completion, an average of 3 year

  • +1 more secondary outcomes

Other Outcomes (1)

  • Diabetes complications

    through study completion, an average of 3 year

Study Arms (2)

Traditional therapy group

NO INTERVENTION

All patients in this group will be given routine diabetes management, including lifestyle education, health guidance, monitoring blood sugar guidance and drug adjustment.

Shared Care group

ACTIVE COMPARATOR

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

Interventions

Shared Care diabetes managementBEHAVIORAL

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.

Shared Care group

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients diagnosed with T2DM
  • Patients who have Informed and signed the consent form content
  • Patients can be regularly followed (every 3 months) for at least 3 years

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Beijing Chao-Yang Hospital, Capital Medical University

Beijing, Beijing Municipality, China

Location

Related Publications (12)

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

    BACKGROUND

  • [A mass survey of diabetes mellitus in a population of 300,000 in 14 provinces and municipalities in China (author's transl)]. Zhonghua Nei Ke Za Zhi. 1981 Nov;20(11):678-83. No abstract available. Chinese.

    PMID: 7341098BACKGROUND

  • Pan XR, Yang WY, Li GW, Liu J. Prevalence of diabetes and its risk factors in China, 1994. National Diabetes Prevention and Control Cooperative Group. Diabetes Care. 1997 Nov;20(11):1664-9. doi: 10.2337/diacare.20.11.1664.

    PMID: 9353605BACKGROUND

  • Yang W, Lu J, Weng J, Jia W, Ji L, Xiao J, Shan Z, Liu J, Tian H, Ji Q, Zhu D, Ge J, Lin L, Chen L, Guo X, Zhao Z, Li Q, Zhou Z, Shan G, He J; China National Diabetes and Metabolic Disorders Study Group. Prevalence of diabetes among men and women in China. N Engl J Med. 2010 Mar 25;362(12):1090-101. doi: 10.1056/NEJMoa0908292.

    PMID: 20335585BACKGROUND

  • Wang L, Gao P, Zhang M, Huang Z, Zhang D, Deng Q, Li Y, Zhao Z, Qin X, Jin D, Zhou M, Tang X, Hu Y, Wang L. Prevalence and Ethnic Pattern of Diabetes and Prediabetes in China in 2013. JAMA. 2017 Jun 27;317(24):2515-2523. doi: 10.1001/jama.2017.7596.

    PMID: 28655017BACKGROUND

  • Ji LN, Lu JM, Guo XH, Yang WY, Weng JP, Jia WP, Zou DJ, Zhou ZG, Yu DM, Liu J, Shan ZY, Yang YZ, Hu RM, Zhu DL, Yang LY, Chen L, Zhao ZG, Li QF, Tian HM, Ji QH, Liu J, Ge JP, Shi LX, Xu YC. Glycemic control among patients in China with type 2 diabetes mellitus receiving oral drugs or injectables. BMC Public Health. 2013 Jun 21;13:602. doi: 10.1186/1471-2458-13-602.

    PMID: 23800082BACKGROUND

  • Wan EYF, Fung CSC, Jiao FF, Yu EYT, Chin WY, Fong DYT, Wong CKH, Chan AKC, Chan KHY, Kwok RLP, Lam CLK. Five-Year Effectiveness of the Multidisciplinary Risk Assessment and Management Programme-Diabetes Mellitus (RAMP-DM) on Diabetes-Related Complications and Health Service Uses-A Population-Based and Propensity-Matched Cohort Study. Diabetes Care. 2018 Jan;41(1):49-59. doi: 10.2337/dc17-0426. Epub 2017 Nov 14.

    PMID: 29138274BACKGROUND

  • American Diabetes Association. (11) Children and adolescents. Diabetes Care. 2015 Jan;38 Suppl:S70-6. doi: 10.2337/dc15-S014. No abstract available.

    PMID: 25537712BACKGROUND

  • Type 2 diabetes in adults: management. London: National Institute for Health and Care Excellence (NICE); 2015 Dec. Available from http://www.ncbi.nlm.nih.gov/books/NBK338142/

    PMID: 26741015BACKGROUND

  • Bodenheimer T, Wagner EH, Grumbach K. Improving primary care for patients with chronic illness: the chronic care model, Part 2. JAMA. 2002 Oct 16;288(15):1909-14. doi: 10.1001/jama.288.15.1909.

    PMID: 12377092BACKGROUND

  • Bodenheimer T, Wagner EH, Grumbach K. Improving primary care for patients with chronic illness. JAMA. 2002 Oct 9;288(14):1775-9. doi: 10.1001/jama.288.14.1775.

    PMID: 12365965BACKGROUND

  • Wagner EH, Grothaus LC, Sandhu N, Galvin MS, McGregor M, Artz K, Coleman EA. Chronic care clinics for diabetes in primary care: a system-wide randomized trial. Diabetes Care. 2001 Apr;24(4):695-700. doi: 10.2337/diacare.24.4.695.

    PMID: 11315833BACKGROUND

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Central Study Contacts

Jia Liu, MD

CONTACT

861085231710liujia0116@126.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: This is a prospective, randomization, parallel, controlled study.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor and Director, Department of Endocrinology

Study Record Dates

First Submitted

September 17, 2019

First Posted

September 24, 2019

Study Start

January 1, 2020

Primary Completion

December 31, 2023

Study Completion

December 31, 2023

Last Updated

September 24, 2019

Record last verified: 2019-09

Locations

CN(1)