Investigating the Syndrome Differentiation of Diabetic and Pre-diabetic Using Digitalized TCM Diagnostic Tools

NCT05563090 | Completed

• 1 other identifier: SCHMI-2022-001
• Study Type: observational
• Target: 171
• Locations: 1 country
• Sites: 1

Brief 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 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.

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; Pulse diagnosis; Tongue diagnosis

Outcome Measures

Primary Outcomes (4)

• 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.

  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.

  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.

  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.

  One-time assessment within 30mins after undergoing the questionnaires

Secondary Outcomes (10)

• Health Evaluation - Age

  One-time assessment within 30mins before undergoing the tongue and pulse diagnosis.

• Health Evaluation - Gender

  One-time assessment within 30mins before undergoing the tongue and pulse diagnosis.

• Health Evaluation - Weight

  One-time assessment within 30mins before undergoing the tongue and pulse diagnosis.

• Health Evaluation - Height

  One-time assessment within 30mins before undergoing the tongue and pulse diagnosis.

• Health Evaluation - BMI

  One-time assessment within 30mins before undergoing the tongue and pulse diagnosis.

Study Arms (5)

0HEA

Healthy or sub-healthy subject without clinically diagnosed chronic conditions such as diabetes, hypertension or dyslipidemia

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

Other: Questionnaires+Tongue diagnosis+Pulse diagnosis

2DIA

Diabetes with FPG of ≥ 7.0 mmol/L, 2hPG of ≥ 11.1mmol, or HbA1c of \> 6.5%

Other: Questionnaires+Tongue diagnosis+Pulse diagnosis

3PREHD

Prediabetes with hypertension and dyslipidemia

Other: Questionnaires+Tongue diagnosis+Pulse diagnosis

4DIAHD

Diabetes with hypertension and dyslipidemia

Other: Questionnaires+Tongue diagnosis+Pulse diagnosis

Interventions

Questionnaires+Tongue diagnosis+Pulse diagnosis OTHER

Each subject will undergo questionnaires, tongue and pulse diagnosis using modern diagnostic tools

0HEA; 1PRE; 2DIA; 3PREHD; 4DIAHD

Eligibility Criteria

• Age: 21 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• 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

You may not qualify if:

• 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;
• 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

Sponsors & Collaborators

• Singapore Chung Hwa Medical Institution: lead
• Ministry of Health, Singapore: collaborator

Study Sites (1)

Singapore Chung Hwa Medical Institution

Singapore, 319522, Singapore

Location

Related Publications (1)

• 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.

  PMID: 39265161 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus; Glucose Intolerance; Hypertension; Diabetes Mellitus, Type 2; Dyslipidemias

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Hyperglycemia; Vascular Diseases; Cardiovascular Diseases; Lipid Metabolism Disorders

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 25, 2022
• First Posted: October 3, 2022
• Study Start: September 17, 2022
• Primary Completion: April 1, 2025
• Study Completion: April 1, 2025
• Last Updated: May 4, 2025

Record last verified: 2023-12

Locations

SG (1)