Type 2 DMT2DMTHNCT06719050
Telehealth-Based Chronic Disease Management for Type 2 Diabetes
An observational study of Type 2 DM, run by Zeng Lin, Ph. D..
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Type 2 DM
- How many people
- 1,636 participants
- Where
- No sites listed yet
- Study dates
- 18 Dec 2024to 31 Dec 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Application and Evaluation of 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.
- Conditions
- Type 2 DM
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| online + offline integrated management in the Internet hospital | Not described | |
| Routine offline management mode | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
the proportion of patients achieved all three targets (HbA1c < 7.0%, blood pressure < 130/80 mmHg and LDL-cholesterol < 2.6 mmol/L)
Measured: at 6±1 month from the enrollment
Secondary outcomes (22)
patient adherence using 8-item Morisky Medication Adherence Scale (MMAS-8)
Measured: at 3±1 month from the enrollment
patient satisfaction using Visual Analogue Scale (VAS)
Measured: at 3±1 month from the enrollment
Hypoglycemic events
Measured: at 3±1 month from the enrollment
Acute complications
Measured: at 3±1 month from the enrollment
Hospitalization for any reason
Measured: at 3±1 month from the enrollment
blood glucose level
Measured: at 3±1 month from the enrollment
blood pressure assessment
Measured: at 3±1 month from the enrollment
Laboratory tests for blood lipid level (Low Density Lipoprotein-Cholesterol, LDL-C)
Measured: at 3±1 month from the enrollment
patient adherence using 8-item Morisky Medication Adherence Scale (MMAS-8)
Measured: at 6±1 month from the enrollment
patient satisfaction using Visual Analogue Scale (VAS)
Measured: at 6±1 month from the enrollment
blood glucose level
Measured: at 6±1 month from the enrollment
blood pressure assessment
Measured: at 6±1 month from the enrollment
diabetes self-management ability using Summary of Diabetes Self-Care Activities Questionnaire (C-SDSCA)
Measured: at 6±1 month from the enrollment
diabetes self-management ability using Confidence in Diabetes Management Self-Efficacy Scale (C-DMSES)
Measured: at 6±1 month from the enrollment
Direct Medical Cost
Measured: at 6±1 month from the enrollment
Laboratory tests for blood lipid level (Total Cholesterol, TC)
Measured: at 6±1 month from the enrollment
Laboratory tests for blood lipid level (Triglycerides, TG)
Measured: at 6±1 month from the enrollment
Laboratory tests for blood lipid level (Low Density Lipoprotein-Cholesterol, LDL-C)
Measured: at 6±1 month from the enrollment
Laboratory tests for blood lipid level (High Density Lipoprotein-Cholesterol, HDL-C)
Measured: at 6±1 month from the enrollment
Hypoglycemic events
Measured: at 6±1 month from the enrollment
Acute complications
Measured: at 6±1 month from the enrollment
Hospitalization for any reason
Measured: at 6±1 month from the enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2024
- Study start18 Dec 2024 (estimated)
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 DMStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,636 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zeng Lin, Ph. D.
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Zeng Lin, Ph. D., Peking University Third Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06719050
- Sponsor's protocol ID
- SF2024-2G-4097
- Acronym
- T2DMTH
- Status last verified
- Dec 2024
- First submitted
- 28 Nov 2024
- Last updated
- 5 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Application and Evaluation of Telehealth-Based Chronic Disease Management for Type 2 Diabetes
- ClinicalTrials.gov ID
- NCT06719050
- Acronym / sponsor ID
- T2DMTH / SF2024-2G-4097
- Conditions
- Type 2 DM
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 1,636 participants (estimated)
- Lead sponsor
- Zeng Lin, Ph. D.University, hospital or other
- Study start
- 18 Dec 2024 (estimated)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 5 Dec 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| online + offline integrated management in the Internet hospital | – | – |
| Routine offline management mode | – | – |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (6 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
22 secondary outcomes
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
diabetes self-management ability using Summary of Diabetes Self-Care Activities Questionnaire (C-SDSCA)
Time frame: at 6±1 month from the enrollment
diabetes self-management ability using Confidence in Diabetes Management Self-Efficacy Scale (C-DMSES)
Time frame: at 6±1 month from the enrollment
Direct Medical Cost
Time frame: at 6±1 month from the enrollment
Laboratory tests for blood lipid level (Total Cholesterol, TC)
Time frame: at 6±1 month from the enrollment
Laboratory tests for blood lipid level (Triglycerides, TG)
Time frame: at 6±1 month from the enrollment
Laboratory tests for blood lipid level (Low Density Lipoprotein-Cholesterol, LDL-C)
Time frame: at 6±1 month from the enrollment
Laboratory tests for blood lipid level (High Density Lipoprotein-Cholesterol, HDL-C)
Time frame: at 6±1 month from the enrollment
Hypoglycemic events
Time frame: at 6±1 month from the enrollment
Acute complications
Time frame: at 6±1 month from the enrollment
Hospitalization for any reason
Time frame: at 6±1 month from the enrollment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Dec 2024.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
An observational study of Type 2 DM, run by Zeng Lin, Ph. D..
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 5 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Lin Zeng (86+13811401686, zlwhy@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Dec 2024.