Diabetes Mellitus Type 2NCT07129148
Mobile Health and Wearable Devices for Diabetes Complication Management
A study testing Device: No specific devices, Device: CGM,CGM management platform and Device: "Professor Tang" WeChat Mini-program in people with Diabetes Mellitus Type 2 and Diabetes Mellitus Complications, run by Second Xiangya Hospital of Central South University at 1 site in China.
Trial summary
The value of intelligent lifestyle intervention for T2D and its complications has been initially explored, but evidence-based support for the effectiveness of related AI risk prediction models and intervention models remains to be confirmed. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetes Mellitus Type 2, Diabetes Mellitus Complications
- What is being tested?
- Device: No specific devices, Device: CGM,CGM management platform and Device: "Professor Tang" WeChat Mini-program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6,000 participants
- Where
- 1 siteChina
- Study dates
- 1 Oct 2025to 1 Oct 2027
- Phase
- Interventional
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Confirmed diagnosis of Type 2 Diabetes;
- Aged ≥ 18 years;
- Able to accept the diabetes management model with AI-assisted management and wearable device monitoring;
- Able to provide complete lifestyle records, including medical history, medication status, diet, exercise, etc.;
- Fully understand the purpose, nature, and methods of the study, voluntarily participate in this study, accept a 3-month follow-up, and sign the informed consent form.
Who cannot join
- Having severe mental illness or language barriers;
- Suffering from malignant tumors;
- Pregnant or lactating women;
- Suspected active infections (such as active pulmonary tuberculosis, pneumonia, etc.);
- Severe hepatic and renal insufficiency (alanine transaminase and/or aspartate transaminase > 3 times the upper limit of normal; estimated glomerular filtration rate < 15 mL/min/1.73 m²);
- A history of definite major adverse cardiovascular events and/or revascularization and/or intravenous thrombolysis and/or endovascular thrombectomy;
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- Uncontrolled hyperthyroidism or hypothyroidism, pituitary-adrenal dysfunction, or other endocrine diseases;
- Alcoholism or drug addiction;
- Receiving insulin therapy;
- Unable to accept new comprehensive intervention technologies for various reasons (such as personal beliefs, economic factors, etc.).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Second Xiangya Hospital of Central South University
Changsha
周, 86-0731-85292223, houdezhou@csu.edu.cn
About this study
Official title: Study on the Applicability of New Technologies for Diabetes Complication Management Based on Mobile Health and Wearable Devices
The value of intelligent lifestyle intervention for T2D and its complications has been initially explored, but evidence-based support for the effectiveness of related AI risk prediction models and intervention models remains to be confirmed. The primary objective of this study is to verify the effectiveness of an AI model for predicting the risk of T2D complications based on phenotype, laboratory indicators and wearable device indicators, and to explore the effect and applicability of an intelligent lifestyle intervention model combining wearable devices and smartphones in preventing T2D complications.
- Being tested
- Device: No specific devices, Device: CGM,CGM management platform, Device: "Professor Tang" WeChat Mini-program, Device: CGM, Smart Bracelet, "Professor Tang" WeChat Mini-program
- Medical subject headings
- Diabetes Mellitus, Type 2, Diabetes Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Device: No specific devicesOther
Routine doctor-patient interaction.
Device: CGM,CGM management platformOther
Wearable monitoring + CGM management platform-assisted administration
Device: "Professor Tang" WeChat Mini-programOther
Mini-program-assisted health management
Device: CGM, Smart Bracelet, "Professor Tang" WeChat Mini-programOther
Wearable monitoring + mini-program integrated management
| Study group | Role | What they receive |
|---|---|---|
| Control: Traditional Control | Other | Adopt classic doctor-patient interaction management; receive diet and exercise education upon enrollment, self-monitor blood glucose at home and keep a diary. Receives: Other: Device: No specific devices |
| Experimental: Wearable Devices + Data Management Platform | Other | On the basis of classic management, wear CGM , load CGM management software, and monitor health data in real time via mobile software. Receives: Other: Device: CGM,CGM management platform |
| Experimental:WeChat mini-program Smart Management | Other | On the basis of classic management, use the "Professor Tang" WeChat mini-program for blood glucose recording and diet/exercise management. Receives: Other: Device: "Professor Tang" WeChat Mini-program |
| Experimental:Wearable Devices + WeChat mini-program Management | Other | On the basis of classic management, wear CGM or smartbands , and use the "Professor Tang" WeChat mini-program simultaneously for real-time data monitoring and personalized recommendations. Receives: Other: Device: CGM, Smart Bracelet, "Professor Tang" WeChat Mini-program |
What is being measured
The primary outcome is the main question the study is designed to answer.
HbA1c
Between-group differences in HbA1c change (from Central Lab)
Measured: Baseline, 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2025
- Study start1 Oct 2025
- Primary completion1 Oct 2026 (estimated)
- Study completion1 Oct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes Mellitus Type 2Studies of the same condition, open and under way.
- More trials run by Second Xiangya Hospital of Central South UniversityThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 6,000 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- First Hospital of China Medical University, The First Affiliated Hospital with Nanjing Medical University, First Affiliated Hospital of Harbin Medical University, Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University, First Affiliated Hospital of Kunming Medical University, Tianjin Medical University, Shanghai 6th People's Hospital, Jinjiang Municipal Hospital, Shanghai Sixth People's Hospital Fujian Campus, Sinocare
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07129148
- Sponsor's protocol ID
- LYEC2024-0331
- Status last verified
- May 2026
- First submitted
- 6 Aug 2025
- Last updated
- 1 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study on the Applicability of New Technologies for Diabetes Complication Management Based on Mobile Health and Wearable Devices
- ClinicalTrials.gov ID
- NCT07129148
- Acronym / sponsor ID
- LYEC2024-0331
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 6,000 participants (estimated)
- Lead sponsor
- Second Xiangya Hospital of Central South UniversityUniversity, hospital or other
- Collaborators
- First Hospital of China Medical University, The First Affiliated Hospital with Nanjing Medical University, First Affiliated Hospital of Harbin Medical University, Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University, First Affiliated Hospital of Kunming Medical University, Tianjin Medical University, Shanghai 6th People's Hospital, Jinjiang Municipal Hospital, Shanghai Sixth People's Hospital Fujian Campus, Sinocare
- Study start
- 1 Oct 2025 (actual)
- Primary completion
- 1 Oct 2026 (estimated)
- Study completion
- 1 Oct 2027 (estimated)
- First posted
- 19 Aug 2025 (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.
The value of intelligent lifestyle intervention for T2D and its complications has been initially explored, but evidence-based support for the effectiveness of related AI risk prediction models and intervention models remains to be confirmed. The primary objective of this study is to verify the effectiveness of an AI model for predicting the risk of T2D complications based on phenotype, laboratory indicators and wearable device indicators, and to explore the effect and applicability of an intelligent lifestyle intervention model combining wearable devices and smartphones in preventing T2D complications.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Control: Traditional Control | Other | Other: Device: No specific devicesAdopt classic doctor-patient interaction management; receive diet and exercise education upon enrollment, self-monitor blood glucose at home and keep a diary. |
| Experimental: Wearable Devices + Data Management Platform | Other | Other: Device: CGM,CGM management platformOn the basis of classic management, wear CGM , load CGM management software, and monitor health data in real time via mobile software. |
| Experimental:WeChat mini-program Smart Management | Other | Other: Device: "Professor Tang" WeChat Mini-programOn the basis of classic management, use the "Professor Tang" WeChat mini-program for blood glucose recording and diet/exercise management. |
| Experimental:Wearable Devices + WeChat mini-program Management | Other | Other: Device: CGM, Smart Bracelet, "Professor Tang" WeChat Mini-programOn the basis of classic management, wear CGM or smartbands , and use the "Professor Tang" WeChat mini-program simultaneously for real-time data monitoring and personalized recommendations. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Confirmed diagnosis of Type 2 Diabetes;
- Aged ≥ 18 years;
- Able to accept the diabetes management model with AI-assisted management and wearable device monitoring;
- Able to provide complete lifestyle records, including medical history, medication status, diet, exercise, etc.;
- Fully understand the purpose, nature, and methods of the study, voluntarily participate in this study, accept a 3-month follow-up, and sign the informed consent form.
Key exclusion criteria (10 listed)
- Having severe mental illness or language barriers;
- Suffering from malignant tumors;
- Pregnant or lactating women;
- Suspected active infections (such as active pulmonary tuberculosis, pneumonia, etc.);
- Severe hepatic and renal insufficiency (alanine transaminase and/or aspartate transaminase > 3 times the upper limit of normal; estimated glomerular filtration rate < 15 mL/min/1.73 m²);
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Device: No specific devicesRoutine doctor-patient interaction. | Other | Control: Traditional Control |
| Device: CGM,CGM management platformWearable monitoring + CGM management platform-assisted administration | Other | Experimental: Wearable Devices + Data Management Platform |
| Device: "Professor Tang" WeChat Mini-programMini-program-assisted health management | Other | Experimental:WeChat mini-program Smart Management |
| Device: CGM, Smart Bracelet, "Professor Tang" WeChat Mini-programWearable monitoring + mini-program integrated management | Other | Experimental:Wearable Devices + WeChat mini-program Management |
Primary outcome
HbA1c
Time frame: Baseline, 1 year
Between-group differences in HbA1c change (from Central Lab)
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 1 Jun 2026.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Device: No specific devices, Device: CGM,CGM management platform and Device: "Professor Tang" WeChat Mini-program in people with Diabetes Mellitus Type 2 and Diabetes Mellitus Complications, run by Second Xiangya Hospital of Central South University at 1 site in China.
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 10 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: looking for participants now, as of the sponsor's last update on 1 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
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 HouDe Zhou, Prof. (86-0731-85292223, houdezhou@csu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
HbA1c (time frame: Baseline, 1 year). 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 1 Jun 2026.