An interventional study of POC-cHbA1c and Fingerstick RBG in Type 2 Diabetes and Pre-diabetes, sponsored by The University of Hong Kong. Not yet recruiting at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-07-28.
Sponsored by The University of Hong Kong · Not applicable, Interventional, and Screening
This project aims to compare Point-of-care capillary HbA1c (POC-cHbA1c) testing and fingerstick random blood glucose (RBG) testing in terms of type 2 diabetes detection rate and cost-effectiveness, in order to optimise current screening strategies for rural populations at high risk of diabetes in rural Dali, China, and to improve treatment adherence and self-management among people with diabetes.
This is a cluster randomised controlled trial conducted in rural Dali, Yunnan, China, to evaluate the effectiveness and cost-effectiveness of point-of-care capillary HbA1c testing (POC-cHbA1c) for screening type 2 diabetes among high-risk individuals. The study will involve six township health centres in rural Dali. The intervention group will receive immediate on-site POC-cHbA1c testing, while the control group will undergo fingerstick RBG testing, with both groups having confirmatory vHbA1c testing for validation. Primary outcome is the detection rates of T2DM, while secondary outcomes include the detection rate of pre-diabetes, sensitivity, specificity, and economic evaluations such as the incremental cost-effectiveness ratio (ICER). The findings are intended to inform optimized screening strategies in rural settings, potentially leading to earlier diagnosis, better treatment adherence, and improved health outcomes in rural populations at high risk of diabetes.
10,371 studies on the registry are indexed under Diabetes Mellitus, Type 2; 1,406 are open to participants now.
This study's planned enrollment of 720 is above the median of 80 across 8,350 interventional studies indexed under Diabetes Mellitus, Type 2.
Browse Diabetes Mellitus, Type 2 studies →The University of Hong Kong is the lead sponsor of 1,292 studies on the registry; 348 are open to participants now.
Of its 9 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HbA1c
A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
POC-cHbA1c + vHbA1c
Diagnostic Test: POC-cHbA1c
Fingerstick RBG + vHbA1c
Diagnostic Test: Fingerstick RBG
Research staff will use quality-certified POC HbA1c devices to perform finger-prick capillary HbA1c testing for participants. Testing will be completed on site and results will be provided immediately.
Research staff will use standardised glucometers and test strips to measure fingerstick random blood glucose. Test results will be provided on site.
Detection rate of T2DM
Time frame: 1 week
Detection rate of pre-diabetes
Time frame: 1 week
Sensitivity and specificity
Time frame: 1 week
Number needed to screen
Time frame: 1 week
Incremental cost-effectiveness ratio
Time frame: 3 months and 6 months
Proportion of treatment adherence
Treatment adherence will be measured by the Medication Adherence Report Scale - 5 items, MARS-5
Time frame: 3 months and 6 months
Score of diabetes self-management
The level of diabetes self-managment will be calculated as a score using the Summary of Diabetes Self-Care Activities - 6 items (SDSCA-6).
Time frame: 3 months and 6 months
Venous HbA1c levels
Time frame: 3 months and 6 months
Treatment-related adverse event
Hypoglycaemia, anxiety and depression, etc.
Time frame: 3 months and 6 months
Level of satisfaction with the screening method
The level of satisfaction with the screening method will be evaluated using a 5-point Likert item (very disappointed, disappointed, neutral, satisfied, very satisfied).
Time frame: 3 months and 6 months
Plan to share: No
No publications or documents are linked to this record.
Start is estimated for Jul 2026; primary completion for Jul 2027, 12 months later.
Of 2,066 non-industry interventional studies with no phase under Diabetes Mellitus, Type 2, half reached primary completion within 21 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 40. This study's planned 12 months is below that.
Counting every sponsor, half of 2,243 studies reached it within 21 months; a quarter within 10 and three quarters within 39.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Jul 2026. You cannot join it, but the record below documents what was studied.
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