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Development and Validation of DM and Pre-DM Risk Prediction Model

NCT04881383 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 1014

Last updated 2024-12-10

No results posted yet for this study

Summary

Many DM and pre-DM remain undiagnosed. The aim is to develop and validate a risk prediction function to detect DM and pre-DM in Chinese adults aged 18-84 in primary care (PC). The objectives are to:

1. Develop a risk prediction function using non-laboratory parameters to predict DM and pre-DM from the data of the HK Population Health Survey 2014/2015
2. Develop a risk scoring algorithm and determine the cut-off score
3. Validate the risk prediction function and determine its sensitivity in predicting DM and pre-DM in PC

Hypothesis to be tested:

The prediction function developed from the Population Health Survey (PHS) 2014/2015 is valid and sensitive in PC.

Design and subjects:

We will develop a risk prediction function for DM and pre-DM using data of 1,857 subjects from the PHS 2014/2015. We will recruit 1014 Chinese adults aged 18-84 from PC clinics to validate the risk prediction function. Each subject will complete an assessment on the relevant risk factors and have a blood test on OGTT and HbA1c on recruitment and at 12 months.

Main outcome measures:

The area under the Receiver operating characteristic (ROC) curve, sensitivity and specificity of the prediction function.

Data analysis and expected results:

Machine learning and Logistic regressions will be used to develop the best model. ROC curve will be used to determine the cut-off score. Sensitivity and specificity will be determined by descriptive statistics. A new HK Chinese general population specific risk prediction function will enable early case finding and intervention to prevent DM and DM complications in PC.

Conditions

Interventions

DIAGNOSTIC_TEST

OGTT and HbA1c

An investigation form will be given to the patient to attend an approved private laboratory for blood pressure, weight, height, waist and hip circumferences, and a blood test on OGTT, HbA1c, complete blood count (CBC) and lipid profile within three months

Sponsors & Collaborators

  • The University of Hong Kong

    lead OTHER

Principal Investigators

  • Cindy LK Lam, MD · Department of Family Medicine and Primary Care, University of Hong Kong

Eligibility

Min Age
18 Years
Max Age
84 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-04-01
Primary Completion
2023-06-30
Completion
2023-09-30

Countries

  • Hong Kong

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04881383 on ClinicalTrials.gov