Telehealth-Based Chronic Disease Management for Type 2 Diabetes

NCT06719050 | Not Yet Recruiting

• 1 other identifier: SF2024-2G-4097
• Study Type: observational
• Target: 1,636
• Locations: 0 countries
• Sites: N/A

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

Outcome Measures

Primary Outcomes (1)

• the proportion of patients achieved all three targets (HbA1c < 7.0%, blood pressure < 130/80 mmHg and LDL-cholesterol < 2.6 mmol/L)

  at 6±1 month from the enrollment

Secondary Outcomes (22)

• patient adherence using 8-item Morisky Medication Adherence Scale (MMAS-8)

  at 3±1 month from the enrollment

• patient satisfaction using Visual Analogue Scale (VAS)

  at 3±1 month from the enrollment

• Hypoglycemic events

  at 3±1 month from the enrollment

• Acute complications

  at 3±1 month from the enrollment

• Hospitalization for any reason

  at 3±1 month from the enrollment

Study Arms (2)

online + offline integrated management in the Internet hospital

Routine offline management mode

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

The study will include patients with type 2 diabetes who did not meet the control target of glucose, blood presure or LDL at the endocrine outpatient clinic and inpatient wards of the Third Hospital of Peking University.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Zeng Lin, Ph. D.: lead

Central Study Contacts

Lin Zeng

CONTACT

86+13811401686; zlwhy@163.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Deputy Director of Peking University Third Hospital Research Center of Clinical Epidemiology

Study Record Dates

• First Submitted: November 28, 2024
• First Posted: December 5, 2024
• Study Start: December 18, 2024
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2027
• Last Updated: December 5, 2024

Record last verified: 2024-12