PrediabetesNCT07354997
Establishing a Virtual Health Community Management Model for Pre-Diabetes Patients
A study testing Pre-diabetes Virtual Community in people with Prediabetes, run by Third Affiliated Hospital, Sun Yat-Sen University at 1 site in China.
Trial summary
This study builds upon the previously developed virtual health community platform, aiming to address the group characteristics and psychological traits of prediabetic patients. By employing intervention mapping to construct a group interaction management model, it seeks to develop a mobile platform integrating… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Prediabetes
- What is being tested?
- Pre-diabetes Virtual Community
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- 22 Dec 2025to 2 Feb 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- Meets the diagnostic criteria for prediabetes: ①impaired fasting glucose (IFG): 6.1 mmol/L ≤ fasting plasma glucose (FPG) < 7.0 mmol/L and 2 h plasma glucose (2-hPG) after a 75 g oral glucose tolerance test (OGTT) < 7.80 mmol/L and impaired glucose tolerance (IGT): FPG<7.0 mmol/L and 7.8 mmol/L ≤ 2 hPG OGTT < 11.1 mmol/L], or HbA1c: 5.7-6.4%;
- Age ≥18 years;
- Clear awareness and comprehension ability;
- Able to use a smartphone and have access to internet at home;
- Willing to participate and sign the informed consent;
- Understand the purpose, procedure and nature of the study.
Who cannot join
- Severe cognitive impairment or mental disorder;
- Complicated with severe malignant tumours;
- Complicated with severe acute or chronic complications such as blindness, heart failure and end-stage renal disease.
Trial locations and contacts
1 site in 1 country.
China1 site
The Third Affiliated Hospital of Sun Yat-sen University
Guangzhou, Guangdong, 510630
About this study
Official title: Research on the Construction and Driving Mechanisms of an Interactive Management Model for Pre-diabetic Patient Groups Based on Virtual Health Communities
This study builds upon the previously developed virtual health community platform, aiming to address the group characteristics and psychological traits of prediabetic patients. By employing intervention mapping to construct a group interaction management model, it seeks to develop a mobile platform integrating "gamified knowledge acquisition and motivation", "immersive lifestyle practice experiences", and "sustained community interaction management". The primary focus is on fostering patients' continuous and proactive engagement. Subsequently, a single-arm controlled trial will validate the model's efficacy, aiming to address the health management challenges faced by China's substantial prediabetic population. This initiative seeks to provide theoretical foundations and practical support for primary prevention strategies targeting other chronic diseases and at-risk cohorts.
- Conditions
- Prediabetes
- Being tested
- Pre-diabetes Virtual Community
- Medical subject headings
- Prediabetic State
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pre-diabetes Virtual CommunityOther
By collecting general information, physical measurements, glucose and lipid metabolism indicators, dietary habits, and exercise routines from prediabetic patients, these details are input into the virtual community programme for prediabetes. The virtual community evaluates the input data, alerts healthcare professionals to patients requiring immediate intervention, and provides guidance for the forthcoming week regarding diet, exercise, and other health aspects (including dietary and exercise advice for prediabetic patients), alongside risk alerts.
| Study group | Role | What they receive |
|---|---|---|
| Pre-diabetes Virtual Community Experience Group | Experimental | Not described Receives: Other: Pre-diabetes Virtual Community |
What is being measured
The primary outcome is the main question the study is designed to answer.
Physical activity
Participants self-reported their daily physical activity levels, with the International Physical Activity Questionnaire (IPAQ) used to assess the frequency, duration, and intensity (i.e., light, moderate, and vigorous activities) of physical activity across different domains (work, transportation, household, and leisure) over the past 7 days.
Measured: From enrolment to the conclusion of the study, 2 weeks.
Diet
Participants self-reported their daily meal consumption through periodic 24-hour dietary recalls or food diaries. These data were then used to calculate the Planetary Health Diet Score, providing a weekly assessment of diet quality.
Measured: From enrolment to the conclusion of the study, 2 weeks.
Fasting blood glucose
Measured: From enrolment to the conclusion of the study, 2 weeks.
Two-hour postprandial blood glucose
Measured: From enrolment to the conclusion of the study, 2 weeks.
Task Completion Rate
Task Completion Rate is defined as the percentage of target users who successfully met the task criteria within the specified time frame and user scope. It directly reflects the implementation efficiency of the intervention and user adherence (e.g., dietary logging rate, exercise plan execution rate).
Formula: Task Completion Rate = (Number of users who successfully completed the task / Total number of target users) × 100%.
Measured: From enrolment to the conclusion of the study, 2 weeks.
Secondary outcomes (5)
Body Mass Index (BMI)
Measured: From enrolment to the conclusion of the study, 2 weeks.
Total cholesterol
Measured: On the first day of enrolment, at the conclusion of the intervention two weeks later.
Triglycerides
Measured: On the first day of enrolment, at the conclusion of the intervention two weeks later.
High-density lipoprotein cholesterol (HDL-C)
Measured: On the first day of enrolment, at the conclusion of the intervention two weeks later.
Low-density lipoprotein cholesterol (LDL-C)
Measured: On the first day of enrolment, at the conclusion of the intervention two weeks later.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jan 2026
- Study start22 Dec 2025
- Primary completion2 Feb 2026
- Study completion2 Feb 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PrediabetesStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Third Affiliated Hospital, Sun Yat-Sen University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xiling Hu, Third Affiliated Hospital, Sun Yat-Sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07354997
- Sponsor's protocol ID
- RG2023-262-03
- Status last verified
- Feb 2026
- First submitted
- 15 Dec 2025
- Last updated
- 12 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Research on the Construction and Driving Mechanisms of an Interactive Management Model for Pre-diabetic Patient Groups Based on Virtual Health Communities
- ClinicalTrials.gov ID
- NCT07354997
- Acronym / sponsor ID
- RG2023-262-03
- Conditions
- Prediabetes
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Third Affiliated Hospital, Sun Yat-Sen UniversityUniversity, hospital or other
- Study start
- 22 Dec 2025 (actual)
- Primary completion
- 2 Feb 2026 (actual)
- Study completion
- 2 Feb 2026 (actual)
- First posted
- 21 Jan 2026 (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 builds upon the previously developed virtual health community platform, aiming to address the group characteristics and psychological traits of prediabetic patients. By employing intervention mapping to construct a group interaction management model, it seeks to develop a mobile platform integrating "gamified knowledge acquisition and motivation", "immersive lifestyle practice experiences", and "sustained community interaction management". The primary focus is on fostering patients' continuous and proactive engagement. Subsequently, a single-arm controlled trial will validate the model's efficacy, aiming to address the health management challenges faced by China's substantial prediabetic population. This initiative seeks to provide theoretical foundations and practical support for primary prevention strategies targeting other chronic diseases and at-risk cohorts.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pre-diabetes Virtual Community Experience Group | Experimental | Other: Pre-diabetes Virtual Community |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Meets the diagnostic criteria for prediabetes: ①impaired fasting glucose (IFG): 6.1 mmol/L ≤ fasting plasma glucose (FPG) < 7.0 mmol/L and 2 h plasma glucose (2-hPG) after a 75 g oral glucose tolerance test (OGTT) < 7.80 mmol/L and impaired glucose tolerance (IGT): FPG<7.0 mmol/L and 7.8 mmol/L ≤ 2 hPG OGTT < 11.1 mmol/L], or HbA1c: 5.7-6.4%;
- Age ≥18 years;
- Clear awareness and comprehension ability;
- Able to use a smartphone and have access to internet at home;
- Willing to participate and sign the informed consent;
Key exclusion criteria (3 listed)
- Severe cognitive impairment or mental disorder;
- Complicated with severe malignant tumours;
- Complicated with severe acute or chronic complications such as blindness, heart failure and end-stage renal disease.
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 |
|---|---|---|
| Pre-diabetes Virtual CommunityBy collecting general information, physical measurements, glucose and lipid metabolism indicators, dietary habits, and exercise routines from prediabetic patients, these details are input into the virtual community programme for prediabetes. The virtual community evaluates the input data, alerts healthcare professionals to patients requiring immediate intervention, and provides guidance for the forthcoming week regarding diet, exercise, and other health aspects (including dietary and exercise advice for prediabetic patients), alongside risk alerts. | Other | Pre-diabetes Virtual Community Experience Group |
Primary outcome
Physical activity
Time frame: From enrolment to the conclusion of the study, 2 weeks.
Participants self-reported their daily physical activity levels, with the International Physical Activity Questionnaire (IPAQ) used to assess the frequency, duration, and intensity (i.e., light, moderate, and vigorous activities) of physical activity across different domains (work, transportation, household, and leisure) over the past 7 days.
Diet
Time frame: From enrolment to the conclusion of the study, 2 weeks.
Participants self-reported their daily meal consumption through periodic 24-hour dietary recalls or food diaries. These data were then used to calculate the Planetary Health Diet Score, providing a weekly assessment of diet quality.
Fasting blood glucose
Time frame: From enrolment to the conclusion of the study, 2 weeks.
Two-hour postprandial blood glucose
Time frame: From enrolment to the conclusion of the study, 2 weeks.
Task Completion Rate
Time frame: From enrolment to the conclusion of the study, 2 weeks.
Task Completion Rate is defined as the percentage of target users who successfully met the task criteria within the specified time frame and user scope. It directly reflects the implementation efficiency of the intervention and user adherence (e.g., dietary logging rate, exercise plan execution rate). Formula: Task Completion Rate = (Number of users who successfully completed the task / Total number of target users) × 100%.
5 secondary outcomes
Body Mass Index (BMI)
Time frame: From enrolment to the conclusion of the study, 2 weeks.
Total cholesterol
Time frame: On the first day of enrolment, at the conclusion of the intervention two weeks later.
Triglycerides
Time frame: On the first day of enrolment, at the conclusion of the intervention two weeks later.
High-density lipoprotein cholesterol (HDL-C)
Time frame: On the first day of enrolment, at the conclusion of the intervention two weeks later.
Low-density lipoprotein cholesterol (LDL-C)
Time frame: On the first day of enrolment, at the conclusion of the intervention two weeks later.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Feb 2026.
Related trials for Prediabetes
Recruiting
Effects of Lean Pork Loin Intake on Protein Homeostasis and Glucose Regulation in Prediabetic Adults
Hyperglycaemia (Non Diabetic), Prediabetes
RecruitingObservational study
Food-i-Sense Analytics: Integrating AI Into Continuous Glucose Monitoring Data Analysis for Precision Nutrition.
Prediabetes (Insulin Resistance, Impaired Glucose Tolerance), Artificial Intelligence Mobile Application
RecruitingPhase 3
A Study of Orforglipron in Participants With Overweight at Risk of Development of Obesity-Related Complications or Progression to Class 1 Obesity
Overweight, Prediabetic State
Enrolling by invitationEarly Phase 1
Truway Diagnostic Tools in Primary Care
Chronic Disease, Type 2 Diabetes Mellitus (T2DM), Obesity, Overweight
Recruiting
CGM-Enhanced DPP to Prevent Type 2 Diabetes in Adults With Prediabetes
PreDiabetes
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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pre-diabetes Virtual Community in people with Prediabetes, run by Third Affiliated Hospital, Sun Yat-Sen 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 6 inclusion and 3 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: finished, as of the sponsor's last update on 12 Feb 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Physical activity (time frame: From enrolment to the conclusion of the study, 2 weeks.). The study lists 5 primary outcomes in all. 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 12 Feb 2026.