Investigating the Syndrome Differentiation of Diabetic and Pre-diabetic Patients in Singapore Using Digitalized TCM Diagnostic Tools: an Observational Study
Trial ID: NCT05563090
Status: COMPLETED
Study type: OBSERVATIONAL
Start date: 2022-09-17
Completion date: 2025-04-01
Sponsor: Singapore Chung Hwa Medical Institution
Collaborators: Ministry of Health, Singapore
Conditions: Diabete Mellitus; Pre-diabetes; Healthy; Hypertension; Dyslipidemia Associated With Type II Diabetes Mellitus
Interventions: Questionnaires+Tongue diagnosis+Pulse diagnosis
Locations: Singapore Chung Hwa Medical Institution
Countries: Singapore
Enrollment: 171
Age range: 21 Years - 75 Years
Sex: ALL

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 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 conditions such as diabetes, hypertension or dyslipidemia

Exclusion Criteria:

* 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

Outcomes:
The Constitution in Chinese Medicine Questionnaire (CCMQ); Physical Activity Questionnaire and sugar intake; Pulse sphygmograph; Tongue imaging device