Telehealth-Based Chronic Disease Management for Type 2 Diabetes

NCT ID: NCT06719050

Last Updated: 2024-12-05

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Total Enrollment: 1636 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2024-12-18
• Study Completion Date: 2027-12-31

Brief Summary

This study will be conducted from enrollment until the end of the six-month follow-up period.

This study aims to assess the impact of the Internet hospital online + offline integrated chronic disease management model on patients with type 2 diabetes mellitus. It will also evaluate the economic impact of the model and identify the characteristics of the appropriate population for the model. Finally, it will develop a toolkit to help manage chronic diseases.

The study will include 1,636 patients with type 2 diabetes who did not reach the standard of control target of glucose, blood pressure or LDL at the endocrine outpatient clinic and inpatient wards of the Third Hospital of Peking University. We will collect information from participants before the study starts. And the patients will be followed up for 6 months from enrollment. The study management mode included online and offline integrated management in the Internet hospital, and routine offline management mode. After completing the enrollment and assessment, we will arrange outpatient follow-up and management according to the current status, doctor's requirements, and study subjects' needs.

Conditions

Type 2 DM

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

online + offline integrated management in the Internet hospital

No interventions assigned to this group

Routine offline management mode

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

• 18-70 years old;
• Confirmed diagnosis of type 2 diabetes mellitus;
• Ability to use smartphones to participate in online diagnosis and treatment;
• Ability of the patient or relatives to assist the patient in self-monitoring of blood glucose;
• Failure to meet control targets: glycated hemoglobin ≥7. 0%, or LDL-C ≥ 2.6 mmol/L (and ASCVD or definite atherosclerosis with stenosis ≥ 1.8 mmol/L), or blood pressure > 130% and ≥ 1.8 mmol/kg. L), or blood pressure over 130/80 mmHg.

Exclusion Criteria

• Mental illness, cognitive dysfunction;
• Other diseases and complex conditions (untreated tumors, heart disease within 3 months);
• Acute complications of diabetes, severe hyperglycemia, fasting glucose greater than 16.9 mmol / L, random glucose greater than 20 mmol / L. Diabetic ketoacidosis and hypoglycemic coma that are not suitable for online management of diabetes emergencies;
• Patients with severe chronic complications of diabetes in critical condition (blindness, vision deterioration, new onset of ASCVD symptoms);
• Those who are unsuitable for the study: infection, fracture, trauma, foot ulceration, edema, blindness, cardiovascular emergencies, coma, etc;
• Those who have not signed the informed consent form.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Zeng Lin, Ph. D.

OTHER

Sponsor Role: lead

Responsible Party

Zeng Lin, Ph. D.

Deputy Director of Peking University Third Hospital Research Center of Clinical Epidemiology

Responsibility Role: SPONSOR_INVESTIGATOR

Central Contacts

Lin Zeng

Role: CONTACT

Phone: 86+13811401686

Email: zlwhy@163.com

Other Identifiers

SF2024-2G-4097

Identifier Type: -

Identifier Source: org_study_id