Point-of-care Capillary HbA1c Testing for Type 2 Diabetes Screening Among At-risk Individuals in Rural Dali, China
25. juli 2026 opdateret af: William Chi Wai Wong, The University of Hong Kong
Effectiveness and Cost-Effectiveness of Point-of-care Capillary HbA1c Testing for Type 2 Diabetes Screening Among At-risk Individuals in Rural Dali, Yunnan, China: A Cluster Randomised Controlled 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.
Studieoversigt
Status
Ikke rekrutterer endnu
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
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.
Undersøgelsestype
Interventionel
Tilmelding (Anslået)
720
Fase
- Ikke anvendelig
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiekontakt
- Navn: Levon Yongle Zhan, PhD
- Telefonnummer: 852-25185656
- E-mail: levon@hku.hk
Studiesteder
-
-
Yunnan
-
Dali, Yunnan, Kina, 671000
- The First People's Hospital of Dali
-
Kontakt:
- Libo Yang, BMed
- Telefonnummer: 0872-2121378
- E-mail: 448925216@qq.com
-
-
Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
- Voksen
- Ældre voksen
Tager imod sunde frivillige
Ingen
Beskrivelse
Inclusion Criteria:
- 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;
- Meet at least one of the high-risk criteria for T2DM specified in the Chinese Guidelines for the Prevention and Treatment of Diabetes issued by the Chinese Diabetes Society;
- Able to understand the study information and provide written informed consent.
Exclusion Criteria:
- 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;
- Known haemoglobinopathy, severe anaemia, recent acute blood loss, or history of blood transfusion or blood donation within the past three months;
- Currently receiving treatment that may substantially affect interpretation of HbA1c, such as erythropoietin therapy or recent high-dose iron therapy.
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Screening
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Eksperimentel: Intervention group
POC-cHbA1c + vHbA1c
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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.
|
|
Aktiv komparator: Control group
Fingerstick RBG + vHbA1c
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Research staff will use standardised glucometers and test strips to measure fingerstick random blood glucose.
Test results will be provided on site.
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
Detection rate of T2DM
Tidsramme: 1 week
|
1 week
|
Sekundære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
Detection rate of pre-diabetes
Tidsramme: 1 week
|
1 week
|
|
Sensitivity and specificity
Tidsramme: 1 week
|
1 week
|
|
Number needed to screen
Tidsramme: 1 week
|
1 week
|
|
Incremental cost-effectiveness ratio
Tidsramme: 3 months and 6 months
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3 months and 6 months
|
Andre resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Score of diabetes self-management
Tidsramme: 3 months and 6 months
|
The level of diabetes self-managment will be calculated as a score using the Summary of Diabetes Self-Care Activities - 6 items (SDSCA-6).
|
3 months and 6 months
|
|
Venous HbA1c levels
Tidsramme: 3 months and 6 months
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3 months and 6 months
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|
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Treatment-related adverse event
Tidsramme: 3 months and 6 months
|
Hypoglycaemia, anxiety and depression, etc.
|
3 months and 6 months
|
|
Level of satisfaction with the screening method
Tidsramme: 3 months and 6 months
|
The level of satisfaction with the screening method will be evaluated using a 5-point Likert item (very disappointed, disappointed, neutral, satisfied, very satisfied).
|
3 months and 6 months
|
|
Proportion of treatment adherence
Tidsramme: 3 months and 6 months
|
Treatment adherence will be measured by the Medication Adherence Report Scale - 5 items, MARS-5
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3 months and 6 months
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Efterforskere
- Ledende efterforsker: William Chi Wai Wong, MD, The University of Hong Kong
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Anslået)
28. juli 2026
Primær færdiggørelse (Anslået)
31. juli 2027
Studieafslutning (Anslået)
30. december 2027
Datoer for studieregistrering
Først indsendt
13. juli 2026
Først indsendt, der opfyldte QC-kriterier
17. juli 2026
Først opslået (Faktiske)
22. juli 2026
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
28. juli 2026
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
25. juli 2026
Sidst verificeret
1. juli 2026
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- SYYLL-2026021
Plan for individuelle deltagerdata (IPD)
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