Point-of-care Capillary HbA1c Testing for Type 2 Diabetes Screening Among At-risk Individuals in Rural Dali, China

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorThe University of Hong Kong

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 volunteers

Qualifiers

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

Design model

Parallel

Treatments tested in this trial

  • POC-cHbA1c

    Diagnostic test

    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.

  • Fingerstick RBG

    Diagnostic test

    Research staff will use standardised glucometers and test strips to measure fingerstick random blood glucose. Test results will be provided on site.

Treatment groups

720 Participants
are divided into 2 treatment groups
Group A: Intervention groupExperimental treatment 1 intervention
Group B: Control groupActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Detection rate of T2DM

Time frame
1 week

Secondary outcomes

1

Detection rate of pre-diabetes

Time frame
1 week
2

Sensitivity and specificity

Time frame
1 week
3

Number needed to screen

Time frame
1 week
4

Incremental cost-effectiveness ratio

Time frame
3 months and 6 months

Other outcomes

1

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
2

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
3

Venous HbA1c levels

Time frame
3 months and 6 months
4

Treatment-related adverse event

Hypoglycaemia, anxiety and depression, etc.

Time frame
3 months and 6 months

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

This trial is not recruiting at the moment. You can still explore other options: