NCT04259489

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.

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
210

participants targeted

Target at P75+ for not_applicable type-2-diabetes

Timeline
Completed

Started Jan 2020

Typical duration for not_applicable type-2-diabetes

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

January 14, 2020

Completed
17 days until next milestone

Study Start

First participant enrolled

January 31, 2020

Completed
6 days until next milestone

First Posted

Study publicly available on registry

February 6, 2020

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2022

Completed
Last Updated

February 6, 2020

Status Verified

February 1, 2020

Enrollment Period

2.9 years

First QC Date

January 14, 2020

Last Update Submit

February 5, 2020

Conditions

Type 2 Diabetes

Keywords

Type 2 DiabetesDiabetes Education and ManagementShare Care

Outcome Measures

Primary Outcomes (1)

  • Glycemic achieving rate

    Glycemic achieving rate with HbA1c\<7% at 1-year follow-up

    through study completion, 1 year follow-up

Secondary Outcomes (18)

  • HbA1c change

    through study completion, 1 year follow-up

  • Blood pressure change and rate of reaching the standard

    through study completion, 1 year follow-up

  • LDL-c changes and rate of reaching the standard

    through study completion, 1 year follow-up

  • BMI change and rate of reaching the standard

    through study completion, 1 year follow-up

  • Medicine expenditure change

    through study completion, 1 year follow-up

  • +13 more secondary outcomes

Study Arms (2)

Traditional therapy group

NO INTERVENTION

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.

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 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

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 (13)

  • 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

  • Palmer MJ, Machiyama K, Woodd S, Gubijev A, Barnard S, Russell S, Perel P, Free C. Mobile phone-based interventions for improving adherence to medication prescribed for the primary prevention of cardiovascular disease in adults. Cochrane Database Syst Rev. 2021 Mar 26;3(3):CD012675. doi: 10.1002/14651858.CD012675.pub3.

    PMID: 33769555DERIVED

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

January 14, 2020

First Posted

February 6, 2020

Study Start

January 31, 2020

Primary Completion

December 31, 2022

Study Completion

December 31, 2022

Last Updated

February 6, 2020

Record last verified: 2020-02

Locations

CN(1)