Telehealth-Based Chronic Disease Management for Type 2 Diabetes
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Type 2 DM. Basic parameters: 18 years — 70 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Application and Evaluation of Telehealth-Based Chronic Disease Management for Type 2 Diabetes
Overview
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.
Primary outcome measures
- the proportion of patients achieved all three targets (HbA1c < 7.0%, blood pressure < 130/80 mmHg and LDL-cholesterol < 2.6 mmol/L) [Time frame: at 6±1 month from the enrollment]
Secondary outcome measures (12)
- patient adherence using 8-item Morisky Medication Adherence Scale (MMAS-8) [Time frame: at 3±1 month from the enrollment]
- patient satisfaction using Visual Analogue Scale (VAS) [Time frame: at 3±1 month from the enrollment]
- Hypoglycemic events [Time frame: at 3±1 month from the enrollment]
- Acute complications [Time frame: at 3±1 month from the enrollment]
- Hospitalization for any reason [Time frame: at 3±1 month from the enrollment]
- blood glucose level [Time frame: at 3±1 month from the enrollment]
- blood pressure assessment [Time frame: at 3±1 month from the enrollment]
- Laboratory tests for blood lipid level (Low Density Lipoprotein-Cholesterol, LDL-C) [Time frame: at 3±1 month from the enrollment]
- patient adherence using 8-item Morisky Medication Adherence Scale (MMAS-8) [Time frame: at 6±1 month from the enrollment]
- patient satisfaction using Visual Analogue Scale (VAS) [Time frame: at 6±1 month from the enrollment]
- blood glucose level [Time frame: at 6±1 month from the enrollment]
- blood pressure assessment [Time frame: at 6±1 month from the enrollment]
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT06719050 · SF2024-2G-4097