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

Last updated: April 30, 2025
Sponsor: Singapore Chung Hwa Medical Institution
Overall Status: Completed

Phase

N/A

Condition

Diabetes Mellitus, Type 2

Diabetes Mellitus Types I And Ii

Diabetes (Pediatric)

Treatment

Questionnaires+Tongue diagnosis+Pulse diagnosis

Clinical Study ID

NCT05563090
SCHMI-2022-001
  • Ages 21-75
  • All Genders
  • Accepts Healthy Volunteers

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Aged 21-75 years old, inclusive;

  • Clinically diagnosed with one of the following:

  1. Type II Diabetes Mellitus with or without hypertension and dyslipidemia

  2. Prediabetes with or without hypertension and dyslipidemia

  3. Healthy or sub-healthy subject without clinically diagnosed chronic conditionssuch as diabetes, hypertension or dyslipidemia

Exclusion

Exclusion Criteria:

  • Subjects diagnosed with Gestational Diabetes

  • Subjects who are pregnant or lactating

  • Subjects with chronic heart failure, history of carcinomas with treatment ofchemotherapy/radiotherapy, psychological, or psychiatric disorders

  • Subjects with heart diseases and transplanted devices such as pacemakers;

  • Subjects with acute infections such as upper respiratory infections, acutegastroenteritis, or urinary tract infections;

  • Subjects unable to undergo evaluation with the pulse sphygmograph, tongue detectionor complete the questionnaire;

  • Subjects with communication disorders

  • Subjects with gastroenterology diseases or are diagnosed with 'spleen and stomachdeficiency' (脾胃虚弱)

  • Subjects undergoing TCM treatment for diabetes or pre-diabetes within 1 week

Study Design

Total Participants: 171
Treatment Group(s): 1
Primary Treatment: Questionnaires+Tongue diagnosis+Pulse diagnosis
Phase:
Study Start date:
September 17, 2022
Estimated Completion Date:
April 01, 2025

Study 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.

Connect with a study center

  • Singapore Chung Hwa Medical Institution

    Singapore, 319522
    Singapore

    Site Not Available

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