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Not yet recruitingNCT06719050T2DMTHUpdated Dec 5, 2024

Telehealth-Based Chronic Disease Management for Type 2 Diabetes

An observational study in Type 2 DM, sponsored by Zeng Lin, Ph. D.. Not yet recruiting. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2024-12-05.

Sponsored by Zeng Lin, Ph. D. · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
1,636
Ages
18 Years to 70 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Type 2 DM

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03

In context

Chronic Disease

990 studies on the registry are indexed under Chronic Disease; 178 are open to participants now.

This study's planned enrollment of 1,636 is above the median of 419 across 249 observational studies indexed under Chronic Disease.

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Lead sponsor

This is the only study on the registry with Zeng Lin, Ph. D. as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
No
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.

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

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.
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
1,636 participants (estimated)
Patient registry
No

Groups and cohorts

  • online + offline integrated management in the Internet hospital
  • Routine offline management mode
06

What researchers measure

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

07

Study locations

No study locations are listed for this record.

08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 5, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06719050
Lead sponsor
Zeng Lin, Ph. D.
Responsible party
Zeng Lin, Ph. D. (Deputy Director of Peking University Third Hospital Research Center of Clinical Epidemiology, Peking University Third Hospital) — Sponsor-investigator
First posted
Dec 5, 2024
Start date
Dec 18, 2024 (estimated)
Primary completion
Dec 31, 2026 (estimated)
Completion
Dec 31, 2027 (estimated)
Last update
Dec 5, 2024

Study contacts

Lin Zeng
Contact
zlwhy@163.com
86+13811401686

Oversight

Data monitoring committee
No
FDA-regulated drug
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Dec 2024. You cannot join it, but the record below documents what was studied.

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