About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Aged 18 years or above;
Permanent residents of Dali City who have lived locally for at least six consecutive months;
Registered as rural residents;
No known history of diabetes;
Disqualifiers
Known history of T2DM or currently receiving glucose-lowering treatment;
HbA1c testing with a clear result within the past three months, or completion of standardised diabetes screening within the past six months;
Pregnant or breastfeeding at the time of recruitment;
Active thyroid disease or other active endocrine disorders at recruitment, such as Cushing's syndrome or acromegaly;
Trial design
Parallel
Treatments tested in this trial
POC-cHbA1c
Diagnostic testResearch 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.
Fingerstick RBG
Diagnostic testResearch staff will use standardised glucometers and test strips to measure fingerstick random blood glucose. Test results will be provided on site.
Treatment groups
Trial outcomes
Primary outcomes
Detection rate of T2DM
Secondary outcomes
Detection rate of pre-diabetes
Sensitivity and specificity
Number needed to screen
Incremental cost-effectiveness ratio
Other outcomes
Proportion of treatment adherence
Treatment adherence will be measured by the Medication Adherence Report Scale - 5 items, MARS-5
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).
Venous HbA1c levels
Treatment-related adverse event
Hypoglycaemia, anxiety and depression, etc.
Sponsors and contacts
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