Diabetes MellitusNCT05116319
Prediction to Detect Pre-DM/DM in a Chinese Population
An observational study of Diabetes Mellitus, run by Chinese University of Hong Kong at 1 site in Hong Kong.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 25 years and olderHealthy volunteers can take part
- Conditions the study is for
- Diabetes Mellitus
- What is being tested?
- point-of-care HbA1c
- How many people
- 1,901 participants
- Where
- 1 siteHong Kong
- Study dates
- 1 Feb 2022to 31 Oct 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: General Chinese population
Who may be able to join
- age ≥25 years old
- with no previous diagnosis of DM
- Chinese.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Sensitivity and Specificity of Guidelines' Recommendations and Existing Predictive Models to Detect Undiagnosed Diabetes Mellitus or Prediabetes in a Chinese Population
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.
- Conditions
- Diabetes Mellitus
- Being tested
- point-of-care HbA1c
- Medical subject headings
- Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
point-of-care HbA1cDiagnostic 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%
| Study group | Role | What they receive |
|---|---|---|
| Chinese people with no known history of diabetes | Not described Receives: Diagnostic Test: point-of-care HbA1c |
What is being measured
The primary outcome is the main question the study is designed to answer.
Point-of-care (POC) HbA1c
the measurement to diagnose pre-diabetes or diabetes; pre-DM is diagnosed if HbA1c is 5.7-6.4% and DM is diagnosed if HbA1c is ≥6.5%.
Measured: baseline
Secondary outcomes (2)
Office blood pressure
a measurement to screen for hypertension; BP will be measured for 2 times (1-minute apart) and will be in accordance to the Hong Kong Primary Care Office guideline (e.g. the choice of cuffs and positioning). The average of the two BP readings will be used for analysis and management. Elevated BP is defined as a systolic BP (SBP) of ≥140mmHg and/or a diastolic BP (DBP) ≥90mmHg
Measured: baseline
Body mass index
a measurement for obesity. Body mass index (BMI) is calculated by weight divided by the square of height (BMI = weight (kg)/height(m)2). According the Hong Kong Centre for Health Protection, overweight and obesity are defined as a BMI of 23-24.9kg/m2 and ≥25kg/m2 respectively
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Nov 2021
- Study start1 Feb 2022
- Primary completion29 Aug 2023
- Study completion31 Oct 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes MellitusStudies of the same condition, open and under way.
- More trials run by Chinese University of Hong KongThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Ecologic or community
- Time perspective
- Cross-sectional
- Enrolment
- 1,901 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chinese University of Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lee Kam Pui, Chinese University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05116319
- Sponsor's protocol ID
- CREC-202103
- Status last verified
- Feb 2024
- First submitted
- 20 Oct 2021
- Last updated
- 7 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Will share data upon researchers' reasonable request
Study at a glance
From the registry record, last updated by the sponsor on 7 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sensitivity and Specificity of Guidelines' Recommendations and Existing Predictive Models to Detect Undiagnosed Diabetes Mellitus or Prediabetes in a Chinese Population
- ClinicalTrials.gov ID
- NCT05116319
- Acronym / sponsor ID
- CREC-202103
- Conditions
- Diabetes Mellitus
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,901 participants (actual)
- Lead sponsor
- Chinese University of Hong KongUniversity, hospital or other
- Study start
- 1 Feb 2022 (actual)
- Primary completion
- 29 Aug 2023 (actual)
- Study completion
- 31 Oct 2023 (actual)
- First posted
- 11 Nov 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Ecologic or community
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Chinese people with no known history of diabetes | – | Diagnostic Test: point-of-care HbA1c |
Who may qualify
- Ages
- 25 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- General Chinese population
Key inclusion criteria (3 listed)
- age ≥25 years old
- with no previous diagnosis of DM
- Chinese.
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| point-of-care HbA1cThe 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% | Diagnostic test | Chinese people with no known history of diabetes |
Primary outcome
Point-of-care (POC) HbA1c
Time frame: baseline
the measurement to diagnose pre-diabetes or diabetes; pre-DM is diagnosed if HbA1c is 5.7-6.4% and DM is diagnosed if HbA1c is ≥6.5%.
2 secondary outcomes
Office blood pressure
Time frame: baseline
Body mass index
Time frame: baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Feb 2024.
- Individual participant dataSharing planned: Undecided. Will share data upon researchers' reasonable request
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Diabetes Mellitus, run by Chinese University of Hong Kong at 1 site in Hong Kong.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Point-of-care (POC) HbA1c (time frame: baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Feb 2024.