Diabete MellitusNCT05563090
Investigating the Syndrome Differentiation of Diabetic and Pre-diabetic Using Digitalized TCM Diagnostic Tools
An observational study of Diabete Mellitus and Pre-diabetes, run by Singapore Chung Hwa Medical Institution at 1 site in Singapore.
Trial summary
The investigators aim to objectively identify the Traditional Chinese Medicine (TCM) syndrome differentiation of type II diabetic and prediabetic patients in Singapore through modern technologies thereby potentially increasing the accuracy of identification, diagnosis, and prevention of diabetes and prediabetes… Read more about this study
- Who is it for?
- Ages 21 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Diabete Mellitus, Pre-diabetes, Healthy
- What is being tested?
- Questionnaires+Tongue diagnosis+Pulse diagnosis
- How many people
- 171 participants
- Where
- 1 siteSingapore
- Study dates
- 17 Sep 2022to 1 Apr 2025
- Phase
- Observational
- 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 21 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: The subjects need to be at 21-75 years old, of either gender, with no limitations on race, and is clinically diagnosed by Western medical doctors with either diabetes (FPG of ≥ 7.0 mmol/L, 2hPG of ≥ 11.1mmol, or HbA1c of > 6.5%) or prediabetes (IFG of FPG 6.1-6.9 mmol/L, and/or IGT with 2hPG of 7.8-11.0 mmol/L). Healthy or sub-healthy subjects without any significant health related issues, eg. clinically diagnosed chronic conditions such as diabetes, hypertension or dyslipidemia, will be recruited as the control group. The health evaluation form (Annex 1) will be used to verify that these healthy subjects (1) do not have any family history of diabetes, and (2) do not have unusual high fasting blood glucose detected within one year.
Who may be able to join
- Aged 21-75 years old, inclusive;
- Clinically diagnosed with one of the following:
- Type II Diabetes Mellitus with or without hypertension and dyslipidemia
- Prediabetes with or without hypertension and dyslipidemia
- Healthy or sub-healthy subject without clinically diagnosed chronic conditions such as diabetes, hypertension or dyslipidemia
Who cannot join
- Subjects diagnosed with Gestational Diabetes
- Subjects who are pregnant or lactating
- Subjects with chronic heart failure, history of carcinomas with treatment of chemotherapy/radiotherapy, psychological, or psychiatric disorders
- Subjects with heart diseases and transplanted devices such as pacemakers;
- Subjects with acute infections such as upper respiratory infections, acute gastroenteritis, or urinary tract infections;
- Subjects unable to undergo evaluation with the pulse sphygmograph, tongue detection or complete the questionnaire;
Show all 9Show fewer
- Subjects with communication disorders
- Subjects with gastroenterology diseases or are diagnosed with 'spleen and stomach deficiency' (脾胃虚弱)
- Subjects undergoing TCM treatment for diabetes or pre-diabetes within 1 week
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Investigating the Syndrome Differentiation of Diabetic and Pre-diabetic Patients in Singapore Using Digitalized TCM Diagnostic Tools: an Observational Study
The investigators aim to objectively identify the Traditional Chinese Medicine (TCM) syndrome differentiation of type II diabetic and prediabetic patients in Singapore through modern technologies thereby potentially increasing the accuracy of identification, diagnosis, and prevention of diabetes and prediabetes through a system of targeted treatment. This observational study integrates the concept of TCM diagnostic methods with modern tools aim to provide an objective view on the syndrome differentiation of diabetic and prediabetic patients in Singapore and hence provide a guideline in the treatment options targeted specifically at Singaporeans demographic.
A total of 250 subjects with 50 allocated in each group will be recruited to ensure a sufficient sample size for statistical analysis of the diabetic and prediabetic syndrome differentiation. Subjects aged 21-65 years old, of either gender, with no limitations on race, and is diagnosed with either diabetes (FPG ≥ 7.0 mmol/L, or 2hPG ≥ 11.1mmol) or prediabetes (IFG of FPG 6.1-6.9 mmol/L, and/or IGT with 2hPG of 7.8-11.0 mmol/L) will be included.
Subjective and objective assessments through health evaluation, Physical Activity Questionnaire and Sugar Intake, Constitution in Chinese Medicine Questionnaire, radial pulse diagnosis and tongue diagnosis will be performed for each subject in a single visit. Statistical analysis of assessments will be conducted using unpaired t-test with significance level of p<0.05. Statistical software SPSS 15.0 (SPSS Inc.) will be used for the analysis.
Read the detailed description
Singapore's age-adjusted comparative prevalence of diabetes is at 5.5% in 2019 down from 10.2% in 2010, whereas the global average is at 8.3%. However, approximately 640,000 Singapore citizens 18 years and above are diagnosed with diabetes, and around 650,000 citizens are prediabetic.
The investigators aim to objectively identify the Traditional Chinese Medicine (TCM) syndrome differentiation of type II diabetic and prediabetic patients in Singapore through modern technologies thereby potentially increasing the accuracy of identification, diagnosis, and prevention of diabetes and prediabetes through a system of targeted treatment.
The investigators hypothesize that the TCM syndrome differentiation of 'xiao-ke' in Singapore is different from that of the ones defined in TCM Internal Medicine, which is based on China demographics.
This observational study integrates the concept of TCM diagnostic methods with modern tools aim to provide an objective view on the syndrome differentiation of diabetic and prediabetic patients in Singapore and hence provide a guideline in the treatment options targeted specifically at Singaporeans demographic.
The investigators will attempt to recruit a total of 250 subjects with 50 allocated in each group to ensure a sufficient sample size for statistical analysis of the diabetic and prediabetic syndrome differentiation. Subjects aged 21-75 years old, of either gender, with no limitations on race, and is diagnosed with either diabetes (FPG ≥ 7.0 mmol/L, or 2hPG ≥ 11.1mmol) or prediabetes (IFG of FPG 6.1-6.9 mmol/L, and/or IGT with 2hPG of 7.8-11.0 mmol/L) will be included.
Subjective and objective assessments through health evaluation, Physical Activity Questionnaire and Sugar Intake, Constitution in Chinese Medicine Questionnaire, radial pulse diagnosis and tongue diagnosis will be performed for each subject in a single visit. Statistical analysis of assessments will be conducted using unpaired t-test with significance level of p<0.05. Statistical software SPSS 15.0 (SPSS Inc.) will be used for the analysis.
- Conditions
- Diabete Mellitus, Pre-diabetes, Healthy, Hypertension, Dyslipidemia Associated With Type II Diabetes Mellitus
- Being tested
- Questionnaires+Tongue diagnosis+Pulse diagnosis
- Keywords
- Diabetes Mellitus, Type II diabetes, Pre-diabetes, Healthy subjects, hypertension, dyslipidemia, TCM, TCM diagnosis, Pulse diagnosis, Tongue diagnosis
- Medical subject headings
- Diabetes Mellitus, Glucose Intolerance, Hypertension, Diabetes Mellitus, Type 2, Dyslipidemias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Questionnaires+Tongue diagnosis+Pulse diagnosisOther
Each subject will undergo questionnaires, tongue and pulse diagnosis using modern diagnostic tools
| Study group | Role | What they receive |
|---|---|---|
| 0HEA | Healthy or sub-healthy subject without clinically diagnosed chronic conditions such as diabetes, hypertension or dyslipidemia Receives: Other: Questionnaires+Tongue diagnosis+Pulse diagnosis | |
| 1PRE | Prediabetes with IFG of FPG 6.1-6.9 mmol/L, and/or IGT with 2hPG of 7.8-11.0 mmol/L Receives: Other: Questionnaires+Tongue diagnosis+Pulse diagnosis | |
| 2DIA | Diabetes with FPG of ≥ 7.0 mmol/L, 2hPG of ≥ 11.1mmol, or HbA1c of > 6.5% Receives: Other: Questionnaires+Tongue diagnosis+Pulse diagnosis | |
| 3PREHD | Prediabetes with hypertension and dyslipidemia Receives: Other: Questionnaires+Tongue diagnosis+Pulse diagnosis | |
| 4DIAHD | Diabetes with hypertension and dyslipidemia Receives: Other: Questionnaires+Tongue diagnosis+Pulse diagnosis |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Constitution in Chinese Medicine Questionnaire (CCMQ)
The CCMQ, published by the China Association of Chinese Medicine in 2009, will be adopted to assess the body constitution of each subjects based on TCM principles [26]. Refer to Annex 3.
There are nine different types of body constitution, including (a) Normality; (b) Qi deficiency; (c) Yin deficiency; (d) Yang deficiency; (e) Phlegm-dampness; (f) Damp-heat; (g) Blood stasis; (h) Qi depressed; (i) Inherited special constitution.
Each subject will answer seven to eight questions in each category. The scoring algorithm indicates the likelihood of a specific type of body constitution with a higher score.
Measured: One-time assessment within 30mins before undergoing the tongue and pulse diagnosis.
Physical Activity Questionnaire and sugar intake
Level of physical activity related to the last three months will be recorded through the Physical Activity Questionnaire. Sugar intake includes sweet or carbonated drinks, desserts like chocolates and cakes, 0 - 2, 3 - 6, or more than 7 times a week will also be recorded. Refer to Annex 2.
This will help to identify the risk factors involved and identify the correlation between the body constitutions and various types of 'xiao-ke' based on TCM syndrome differentiation.
Measured: One-time assessment within 30mins before undergoing the tongue and pulse diagnosis.
Pulse sphygmograph
The Asia Plus Pen Pulse Analysis System Model PPAS-93 (Asia Plus Bio Tech Co., Ltd, Taiwan) would be used in the identification of RPPW of the subjects in this study.
The Asia Plus Pen Pulse Analysis System Model PPAS-93 (Figure 11) is a noninvasive device that consist of a high precision pressure sensor pen and a pulse analyzer. The 3D pulse detector is a handheld pen that digitalizes the biological signal of RPPW and provides a graphical analysis. The electronic device contains a high precision pressure sensor, a filter, an amplifier, and a signal recording card connected to signal analysis software. The frequency response is 0.1-50 Hz, and the sampling rate is 3000 Hz.
Measured: One-time assessment within 30mins after undergoing the questionnaires
Tongue imaging device
China Artificial Intelligence Health Status Identification System Model Number YZKJ-SMZY-1AI (Figure 12) will be used in the imaging and analysis of the subject's tongue.
The noninvasive device captures the image of the tongue through an inbuilt camera supported by LED lights within the device. A monitor that is connected to the imaging device would provide a live video feedback on the positioning of the tongue. The images of the subjects' face, tongue, and sublingual collaterals will then be compared and analyzed for the similarities against standard images of tongue analysis using an artificial intelligence system.
Measured: One-time assessment within 30mins after undergoing the questionnaires
Secondary outcomes (10)
Health Evaluation - Age
Demographic information eg age in years will be collected.
Measured: One-time assessment within 30mins before undergoing the tongue and pulse diagnosis.
Health Evaluation - Gender
Demographic information eg gender will be collected.
Measured: One-time assessment within 30mins before undergoing the tongue and pulse diagnosis.
Health Evaluation - Weight
Weight in kilogram will be recorded
Measured: One-time assessment within 30mins before undergoing the tongue and pulse diagnosis.
Health Evaluation - Height
Height in meters will be recorded
Measured: One-time assessment within 30mins before undergoing the tongue and pulse diagnosis.
Health Evaluation - BMI
Weight in kilogram and height in meters will be aggregated to derive the BMI in kg/m^2.
Measured: One-time assessment within 30mins before undergoing the tongue and pulse diagnosis.
Health Evaluation - blood sugar level
Blood glucose in fasting, 2hPG or HbA1c (in mmol/L) results if available in patient's regular blood test report
Measured: One-time assessment within 30mins before undergoing the tongue and pulse diagnosis.
Health Evaluation - Vital signs
Vital signs including systolic blood pressure, diastolic blood pressure in mmHg
Measured: One-time assessment within 30mins before undergoing the tongue and pulse diagnosis.
Health Evaluation - Radial pulse rate
Vital signs including radial pulse rate (bpm)
Measured: One-time assessment within 30mins before undergoing the tongue and pulse diagnosis.
Health Evaluation - Medications
Western and Chinese medications and nutritional supplements consumed by the subjects will be recorded to identify possible intervention and correlation towards TCM syndrome differentiation.
Measured: One-time assessment within 30mins before undergoing the tongue and pulse diagnosis.
Health Evaluation - Existing symptoms
The existing symptoms of subjects will be recorded to identify the possible correlation towards TCM syndrome differentiation.
Measured: One-time assessment within 30mins before undergoing the tongue and pulse diagnosis.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Oct 2022
- Study start17 Sep 2022
- Primary completion1 Apr 2025
- Study completion1 Apr 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Diabete MellitusStudies 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
- Other
- Time perspective
- Prospective
- Enrolment
- 171 participants (actual)
Sponsor and investigators
- Lead sponsor
- Singapore Chung Hwa Medical Institution
- Sponsor type
- University, hospital or other
- Collaborators
- Ministry of Health, Singapore
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05563090
- Sponsor's protocol ID
- SCHMI-2022-001
- Status last verified
- Dec 2023
- First submitted
- 25 Sep 2022
- Last updated
- 4 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Ng HP, Chong SY, Li YH, Goh TH, Pang KY, Pereira MJ, Huang CM. Objective Analysis of Traditional Chinese Medicine Syndrome Differentiation of Patients With Diabetes and Prediabetes: Protocol for a Nonrandomized, Exploratory, Observational Case-Control Study Using Digitalized Traditional Chinese Medicine Diagnostic Tools. JMIR Res Protoc. 2024 Sep 12;13:e56024. doi: 10.2196/56024.
PubMed 39265161
Study at a glance
From the registry record, last updated by the sponsor on 4 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigating the Syndrome Differentiation of Diabetic and Pre-diabetic Patients in Singapore Using Digitalized TCM Diagnostic Tools: an Observational Study
- ClinicalTrials.gov ID
- NCT05563090
- Acronym / sponsor ID
- SCHMI-2022-001
- Conditions
- Diabete Mellitus, Pre-diabetes, Healthy, Hypertension, Dyslipidemia Associated With Type II Diabetes Mellitus
- Keywords
- Diabetes Mellitus, Type II diabetes, Pre-diabetes, Healthy subjects, hypertension, dyslipidemia, TCM, TCM diagnosis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 171 participants (actual)
- Lead sponsor
- Singapore Chung Hwa Medical InstitutionUniversity, hospital or other
- Collaborators
- Ministry of Health, Singapore
- Study start
- 17 Sep 2022 (actual)
- Primary completion
- 1 Apr 2025 (actual)
- Study completion
- 1 Apr 2025 (actual)
- First posted
- 3 Oct 2022 (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 investigators aim to objectively identify the Traditional Chinese Medicine (TCM) syndrome differentiation of type II diabetic and prediabetic patients in Singapore through modern technologies thereby potentially increasing the accuracy of identification, diagnosis, and prevention of diabetes and prediabetes through a system of targeted treatment. This observational study integrates the concept of TCM diagnostic methods with modern tools aim to provide an objective view on the syndrome differentiation of diabetic and prediabetic patients in Singapore and hence provide a guideline in the treatment options targeted specifically at Singaporeans demographic.
A total of 250 subjects with 50 allocated in each group will be recruited to ensure a sufficient sample size for statistical analysis of the diabetic and prediabetic syndrome differentiation. Subjects aged 21-65 years old, of either gender, with no limitations on race, and is diagnosed with either diabetes (FPG ≥ 7.0 mmol/L, or 2hPG ≥ 11.1mmol) or prediabetes (IFG of FPG 6.1-6.9 mmol/L, and/or IGT with 2hPG of 7.8-11.0 mmol/L) will be included.
Subjective and objective assessments through health evaluation, Physical Activity Questionnaire and Sugar Intake, Constitution in Chinese Medicine Questionnaire, radial pulse diagnosis and tongue diagnosis will be performed for each subject in a single visit. Statistical analysis of assessments will be conducted using unpaired t-test with significance level of p<0.05. Statistical software SPSS 15.0 (SPSS Inc.) will be used for the analysis.
Detailed description
Singapore's age-adjusted comparative prevalence of diabetes is at 5.5% in 2019 down from 10.2% in 2010, whereas the global average is at 8.3%. However, approximately 640,000 Singapore citizens 18 years and above are diagnosed with diabetes, and around 650,000 citizens are prediabetic.
The investigators aim to objectively identify the Traditional Chinese Medicine (TCM) syndrome differentiation of type II diabetic and prediabetic patients in Singapore through modern technologies thereby potentially increasing the accuracy of identification, diagnosis, and prevention of diabetes and prediabetes through a system of targeted treatment.
The investigators hypothesize that the TCM syndrome differentiation of 'xiao-ke' in Singapore is different from that of the ones defined in TCM Internal Medicine, which is based on China demographics.
This observational study integrates the concept of TCM diagnostic methods with modern tools aim to provide an objective view on the syndrome differentiation of diabetic and prediabetic patients in Singapore and hence provide a guideline in the treatment options targeted specifically at Singaporeans demographic.
The investigators will attempt to recruit a total of 250 subjects with 50 allocated in each group to ensure a sufficient sample size for statistical analysis of the diabetic and prediabetic syndrome differentiation. Subjects aged 21-75 years old, of either gender, with no limitations on race, and is diagnosed with either diabetes (FPG ≥ 7.0 mmol/L, or 2hPG ≥ 11.1mmol) or prediabetes (IFG of FPG 6.1-6.9 mmol/L, and/or IGT with 2hPG of 7.8-11.0 mmol/L) will be included.
Subjective and objective assessments through health evaluation, Physical Activity Questionnaire and Sugar Intake, Constitution in Chinese Medicine Questionnaire, radial pulse diagnosis and tongue diagnosis will be performed for each subject in a single visit. Statistical analysis of assessments will be conducted using unpaired t-test with significance level of p<0.05. Statistical software SPSS 15.0 (SPSS Inc.) will be used for the analysis.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| 0HEA | – | Other: Questionnaires+Tongue diagnosis+Pulse diagnosisHealthy or sub-healthy subject without clinically diagnosed chronic conditions such as diabetes, hypertension or dyslipidemia |
| 1PRE | – | Other: Questionnaires+Tongue diagnosis+Pulse diagnosisPrediabetes with IFG of FPG 6.1-6.9 mmol/L, and/or IGT with 2hPG of 7.8-11.0 mmol/L |
| 2DIA | – | Other: Questionnaires+Tongue diagnosis+Pulse diagnosisDiabetes with FPG of ≥ 7.0 mmol/L, 2hPG of ≥ 11.1mmol, or HbA1c of > 6.5% |
| 3PREHD | – | Other: Questionnaires+Tongue diagnosis+Pulse diagnosisPrediabetes with hypertension and dyslipidemia |
| 4DIAHD | – | Other: Questionnaires+Tongue diagnosis+Pulse diagnosisDiabetes with hypertension and dyslipidemia |
Who may qualify
- Ages
- 21 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- The subjects need to be at 21-75 years old, of either gender, with no limitations on race, and is clinically diagnosed by Western medical doctors with either diabetes (FPG of ≥ 7.0 mmol/L, 2hPG of ≥ 11.1mmol, or HbA1c of > 6.5%) or prediabetes (IFG of FPG 6.1-6.9 mmol/L, and/or IGT with 2hPG of 7.8-11.0 mmol/L). Healthy or sub-healthy subjects without any significant health related issues, eg. clinically diagnosed chronic conditions such as diabetes, hypertension or dyslipidemia, will be recruited as the control group. The health evaluation form (Annex 1) will be used to verify that these healthy subjects (1) do not have any family history of diabetes, and (2) do not have unusual high fasting blood glucose detected within one year.
Key inclusion criteria (5 listed)
- Aged 21-75 years old, inclusive;
- Clinically diagnosed with one of the following:
Key exclusion criteria (9 listed)
- Subjects diagnosed with Gestational Diabetes
- Subjects who are pregnant or lactating
- Subjects with chronic heart failure, history of carcinomas with treatment of chemotherapy/radiotherapy, psychological, or psychiatric disorders
- Subjects with heart diseases and transplanted devices such as pacemakers;
- Subjects with acute infections such as upper respiratory infections, acute gastroenteritis, or urinary tract infections;
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 |
|---|---|---|
| Questionnaires+Tongue diagnosis+Pulse diagnosisEach subject will undergo questionnaires, tongue and pulse diagnosis using modern diagnostic tools | Other | 0HEA, 1PRE, 2DIA, 3PREHD, 4DIAHD |
Primary outcome
The Constitution in Chinese Medicine Questionnaire (CCMQ)
Time frame: One-time assessment within 30mins before undergoing the tongue and pulse diagnosis.
The CCMQ, published by the China Association of Chinese Medicine in 2009, will be adopted to assess the body constitution of each subjects based on TCM principles [26]. Refer to Annex 3. There are nine different types of body constitution, including (a) Normality; (b) Qi deficiency; (c) Yin deficiency; (d) Yang deficiency; (e) Phlegm-dampness; (f) Damp-heat; (g) Blood stasis; (h) Qi depressed; (i) Inherited special constitution. Each subject will answer seven to eight questions in each category. The scoring algorithm indicates the likelihood of a specific type of body constitution with a higher score.
Physical Activity Questionnaire and sugar intake
Time frame: One-time assessment within 30mins before undergoing the tongue and pulse diagnosis.
Level of physical activity related to the last three months will be recorded through the Physical Activity Questionnaire. Sugar intake includes sweet or carbonated drinks, desserts like chocolates and cakes, 0 - 2, 3 - 6, or more than 7 times a week will also be recorded. Refer to Annex 2. This will help to identify the risk factors involved and identify the correlation between the body constitutions and various types of 'xiao-ke' based on TCM syndrome differentiation.
Pulse sphygmograph
Time frame: One-time assessment within 30mins after undergoing the questionnaires
The Asia Plus Pen Pulse Analysis System Model PPAS-93 (Asia Plus Bio Tech Co., Ltd, Taiwan) would be used in the identification of RPPW of the subjects in this study. The Asia Plus Pen Pulse Analysis System Model PPAS-93 (Figure 11) is a noninvasive device that consist of a high precision pressure sensor pen and a pulse analyzer. The 3D pulse detector is a handheld pen that digitalizes the biological signal of RPPW and provides a graphical analysis. The electronic device contains a high precision pressure sensor, a filter, an amplifier, and a signal recording card connected to signal analysis software. The frequency response is 0.1-50 Hz, and the sampling rate is 3000 Hz.
Tongue imaging device
Time frame: One-time assessment within 30mins after undergoing the questionnaires
China Artificial Intelligence Health Status Identification System Model Number YZKJ-SMZY-1AI (Figure 12) will be used in the imaging and analysis of the subject's tongue. The noninvasive device captures the image of the tongue through an inbuilt camera supported by LED lights within the device. A monitor that is connected to the imaging device would provide a live video feedback on the positioning of the tongue. The images of the subjects' face, tongue, and sublingual collaterals will then be compared and analyzed for the similarities against standard images of tongue analysis using an artificial intelligence system.
10 secondary outcomes
Health Evaluation - Age
Time frame: One-time assessment within 30mins before undergoing the tongue and pulse diagnosis.
Health Evaluation - Gender
Time frame: One-time assessment within 30mins before undergoing the tongue and pulse diagnosis.
Health Evaluation - Weight
Time frame: One-time assessment within 30mins before undergoing the tongue and pulse diagnosis.
Health Evaluation - Height
Time frame: One-time assessment within 30mins before undergoing the tongue and pulse diagnosis.
Health Evaluation - BMI
Time frame: One-time assessment within 30mins before undergoing the tongue and pulse diagnosis.
Health Evaluation - blood sugar level
Time frame: One-time assessment within 30mins before undergoing the tongue and pulse diagnosis.
Health Evaluation - Vital signs
Time frame: One-time assessment within 30mins before undergoing the tongue and pulse diagnosis.
Health Evaluation - Radial pulse rate
Time frame: One-time assessment within 30mins before undergoing the tongue and pulse diagnosis.
Health Evaluation - Medications
Time frame: One-time assessment within 30mins before undergoing the tongue and pulse diagnosis.
Health Evaluation - Existing symptoms
Time frame: One-time assessment within 30mins before undergoing the tongue and pulse diagnosis.
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 4 May 2025.
- Derived from this study: PubMed 39265161Ng HP, Chong SY, Li YH, Goh TH, Pang KY, Pereira MJ, Huang CM. Objective Analysis of Traditional Chinese Medicine Syndrome Differentiation of Patients With Diabetes and Prediabetes: Protocol for a Nonrandomized, Exploratory, Observational Case-Control Study Using Digitalized Traditional Chinese Medicine Diagnostic Tools. JMIR Res Protoc. 2024 Sep 12;13:e56024. doi: 10.2196/56024.
- Individual participant dataSharing planned: Undecided
Related trials for Diabete Mellitus
Not yet recruitingPhase 3
Efficacy and Safety of Once-Weekly SHR-3167 Compared With Once-Daily Insulin Glargine in Adults With Insulin-Naive Type 2 Diabetes
Type 2 Diabetes
Active, not recruiting
Digital Reinforcement of Motivational Interviewing Micro-Skills Among Primary Care Healthcare Professionals
Hypertension (Without Type 2 Diabetes Mellitus)
Recruiting
Effects of Lean Pork Loin Intake on Protein Homeostasis and Glucose Regulation in Prediabetic Adults
Hyperglycaemia (Non Diabetic), Prediabetes
Recruiting
PAW-Hydrogel for Chronic Wound Healing
Diabetic Foot Ulcer (DFU), Pressure Ulcer (PU)
Recruiting
Investigating Vascular Properties of HEMI and SPG Signals in Individuals With or at Risk for Chronic Kidney Disease
Chronic Kidney Disease, Hypertension (HTN)
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?
An observational study of Diabete Mellitus and Pre-diabetes, run by Singapore Chung Hwa Medical Institution at 1 site in Singapore.
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 9 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 4 May 2025. 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 Singapore. 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?
The Constitution in Chinese Medicine Questionnaire (CCMQ) (time frame: One-time assessment within 30mins before undergoing the tongue and pulse diagnosis.). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05563090, which also lists 1 linked publication.
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 4 May 2025.