Prediction to Detect Pre-DM/DM in a Chinese Population

NCT ID: NCT05116319

Last Updated: 2024-02-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

1901 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-02-01

Study Completion Date

2023-10-31

Brief Summary

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This project will compare the sensitivity and specificity of different screening criteria or recommendations to detect pre-diabetes or diabetes mellitus in a Chinese population, using point-of-care hemoglobin A1c.

Detailed Description

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Conditions

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Diabetes Mellitus

Study Design

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Observational Model Type

ECOLOGIC_OR_COMMUNITY

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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Chinese people with no known history of diabetes

point-of-care HbA1c

Intervention Type DIAGNOSTIC_TEST

The Afinion2™ (Abbott, Oslo, Norway), will be used for the current study as it is recently validated. According to American Diabetes Association (ADA), pre-diabetes (pre-DM) is diagnosed if HbA1c is 5.7-6.4% and diabetes (DM) is diagnosed if HbA1c is ≥6.5%

Interventions

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point-of-care HbA1c

The Afinion2™ (Abbott, Oslo, Norway), will be used for the current study as it is recently validated. According to American Diabetes Association (ADA), pre-diabetes (pre-DM) is diagnosed if HbA1c is 5.7-6.4% and diabetes (DM) is diagnosed if HbA1c is ≥6.5%

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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Inclusion Criteria

* age ≥25 years old
* with no previous diagnosis of DM
* Chinese.

Exclusion Criteria

* a history of cardiovascular diseases including any type of stroke, ischemic heart disease, atrial fibrillation, and/or peripheral vascular disease
* severe mental or physical disease or language barriers that limited data collection
Minimum Eligible Age

25 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Chinese University of Hong Kong

OTHER

Sponsor Role lead

Responsible Party

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Lee Kam Pui

Clinical Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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School of public health and primary care

Hong Kong, , Hong Kong

Site Status

Countries

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Hong Kong

Other Identifiers

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CREC-202103

Identifier Type: -

Identifier Source: org_study_id

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