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NCT Number: NCT06719050

Telehealth-Based Chronic Disease Management for Type 2 Diabetes

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.

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Key information

Conditions

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Observational

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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)

    Time frame: at 6±1 month from the enrollment

Secondary outcomes

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

    Time frame: at 3±1 month from the enrollment

  2. patient satisfaction using Visual Analogue Scale (VAS)

    Time frame: at 3±1 month from the enrollment

  3. Hypoglycemic events

    Time frame: at 3±1 month from the enrollment

  4. Acute complications

    Time frame: at 3±1 month from the enrollment

  5. Hospitalization for any reason

    Time frame: at 3±1 month from the enrollment

  6. blood glucose level

    Time frame: at 3±1 month from the enrollment

  7. blood pressure assessment

    Time frame: at 3±1 month from the enrollment

  8. Laboratory tests for blood lipid level (Low Density Lipoprotein-Cholesterol, LDL-C)

    Time frame: at 3±1 month from the enrollment

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

    Time frame: at 6±1 month from the enrollment

  10. patient satisfaction using Visual Analogue Scale (VAS)

    Time frame: at 6±1 month from the enrollment

  11. blood glucose level

    Time frame: at 6±1 month from the enrollment

  12. blood pressure assessment

    Time frame: at 6±1 month from the enrollment

  13. diabetes self-management ability using Summary of Diabetes Self-Care Activities Questionnaire (C-SDSCA)

    Time frame: at 6±1 month from the enrollment

  14. diabetes self-management ability using Confidence in Diabetes Management Self-Efficacy Scale (C-DMSES)

    Time frame: at 6±1 month from the enrollment

  15. Direct Medical Cost

    Time frame: at 6±1 month from the enrollment

  16. Laboratory tests for blood lipid level (Total Cholesterol, TC)

    Time frame: at 6±1 month from the enrollment

  17. Laboratory tests for blood lipid level (Triglycerides, TG)

    Time frame: at 6±1 month from the enrollment

  18. Laboratory tests for blood lipid level (Low Density Lipoprotein-Cholesterol, LDL-C)

    Time frame: at 6±1 month from the enrollment

  19. Laboratory tests for blood lipid level (High Density Lipoprotein-Cholesterol, HDL-C)

    Time frame: at 6±1 month from the enrollment

  20. Hypoglycemic events

    Time frame: at 6±1 month from the enrollment

  21. Acute complications

    Time frame: at 6±1 month from the enrollment

  22. Hospitalization for any reason

    Time frame: at 6±1 month from the enrollment

Study contacts

Contact information is provided by the study sponsor or research team.

Lin Zeng

CONTACT

[email protected]

86+13811401686

Sponsors and collaborators

Lead sponsor

Zeng Lin, Ph. D.

Other

Registry information

Official study title

Application and Evaluation of Telehealth-Based Chronic Disease Management for Type 2 Diabetes

Acronym: T2DMTH

Important dates

Study start
2024
Primary completion
2026
Study completion
2027
First posted
Dec 5, 2024
Registry last updated
Dec 5, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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