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PREDICT-DM: Community Pharmacy-Based Point-of-Care Testing for Undiagnosed T2DM (PREDICT-DM)

26. august 2026 oppdatert av: Rabia Hussain, Universiti Sains Malaysia

PREDICT-DM: Pharmacy-based Rapid Early Detection and Identification of Cases of Type 2 Diabetes Mellitus

The goal of this observational study is to learn whether community pharmacy-based risk assessment and point-of-care HbA1c testing can help detect undiagnosed type 2 diabetes and prediabetes among adults in Irbid Governorate, Jordan, who have no previous diabetes diagnosis.

The main questions it aims to answer are:

What proportion of participants fall into each Finnish Diabetes Risk Score category? What proportion of participants at high or very high risk have HbA1c results within the prediabetes or diabetes range?

Participants will:

Complete the Finnish Diabetes Risk Score questionnaire at a community pharmacy. Receive a finger-prick HbA1c test at the pharmacy if their risk score is 15 or higher.

Visit a general practitioner or primary care facility for diagnostic confirmation if their HbA1c result is abnormal.

Attend follow-up assessments at three and six months if a general practitioner confirms type 2 diabetes.

Studieoversikt

Status

Har ikke rekruttert ennå

Forhold

Detaljert beskrivelse

The study uses a two-phase prospective observational cohort design. No medical treatment will be assigned by the research team.

During the initial screening phase, trained community pharmacists will administer the Arabic-translated eight-item Finnish Diabetes Risk Score. The score includes age, body mass index, waist circumference, physical activity, fruit and vegetable intake, antihypertensive medication use, history of high blood glucose, and family history of diabetes. Scores will be classified as low risk below 7, slightly elevated risk from 7 to 11, moderate risk from 12 to 14, high risk from 15 to 20, and very high risk above 20.

Participants with a score of 15 or higher will undergo capillary point-of-care HbA1c testing at the community pharmacy using the Clover A1c analyser. Results will be classified as normal below 5.7%, within the prediabetes range from 5.7% to 6.4%, or within the diabetes range at 6.5% or higher.

An abnormal pharmacy HbA1c result will not be considered a confirmed diagnosis. These participants will be referred to a general practitioner or primary care facility for clinical assessment and confirmatory laboratory testing. The general practitioner's assessment will determine the final diagnosis and treatment plan.

Participants with general practitioner-confirmed type 2 diabetes will enter a six-month observational follow-up period. The initial pharmacy HbA1c result will serve as the baseline measurement. HbA1c will be reassessed at three and six months. The research team will document referral completion, diagnostic confirmation, treatment initiation, pharmacist-delivered services, and follow-up findings without directing clinical management.

Participating pharmacists will complete standardized training and competency assessment before conducting study procedures. Standard operating procedures will guide risk assessment, capillary blood collection, HbA1c testing, result documentation, counselling, referral, and follow-up.

Studietype

Observasjonsmessig

Registrering (Antatt)

480

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiekontakt

Studiesteder

  • Jordan
    • Irbid Governorate
      • Irbid, Irbid Governorate, Jordan
        • Khaled Pharmacy
        • Ta kontakt med:

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

  • Voksen
  • Eldre voksen

Tar imot friske frivillige

Ja

Prøvetakingsmetode

Ikke-sannsynlighetsprøve

Studiepopulasjon

The study population will consist of adults visiting participating community pharmacies in Irbid Governorate, Jordan, who have no previous diagnosis of diabetes. Participants will be recruited through convenience sampling during routine pharmacy visits. Those classified as having a high or very high diabetes risk will receive community pharmacy-based point-of-care HbA1c testing. Participants with GP-confirmed type 2 diabetes will enter the six-month follow-up cohort.

Beskrivelse

Inclusion Criteria:

  • Aged 18 years or older
  • Lives in Irbid Governorate, Jordan
  • Visits a participating community pharmacy
  • Has not previously been diagnosed with diabetes
  • Can understand and complete the study procedures
  • Provides written informed consent

Exclusion Criteria:

  • Previous diagnosis of diabetes
  • Pregnancy
  • Known anemia
  • Known hemoglobin disorder
  • Blood transfusion within the previous three months
  • A condition that may make the HbA1c result inaccurate
  • A cognitive or communication difficulty that prevents informed consent or

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

Kohorter og intervensjoner

Gruppe / Kohort
Community Pharmacy Visitors Without Diagnosed Diabetes
Adults without a previous diabetes diagnosis will complete FINDRISC screening during a community pharmacy visit. Participants with a score of 15 or higher will receive point-of-care HbA1c testing at the community pharmacy. Those with abnormal HbA1c results will be advised to obtain diagnostic confirmation from a general practitioner or primary care facility. Participants with GP-confirmed type 2 diabetes will enter a six-month follow-up period with HbA1c assessments at three and six months. The study will not assign medical treatment.

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Distribution of Finnish Diabetes Risk Score Categories
Tidsramme: Initial community pharmacy visit on Day 0
Number and percentage of participants classified as low risk below 7, slightly elevated risk from 7 to 11, moderate risk from 12 to 14, high risk from 15 to 20, or very high risk above 20.
Initial community pharmacy visit on Day 0

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
General Practitioner Referral Completion Rate
Tidsramme: Within 3 months after referral
Number and percentage of participants with abnormal pharmacy HbA1c results who attend a general practitioner or primary care facility and complete confirmatory assessment.
Within 3 months after referral
General Practitioner-Confirmed Type 2 Diabetes Diagnosis Rate
Tidsramme: Within 3 months after referral
Number and percentage of participants with abnormal pharmacy HbA1c results who receive a diagnosis of type 2 diabetes following assessment and laboratory testing by a general practitioner.
Within 3 months after referral
Treatment Initiation After Confirmed Type 2 Diabetes
Tidsramme: Through 6 months
Number and percentage of participants with GP-confirmed type 2 diabetes who initiate lifestyle management, oral medication, insulin, or combination treatment.
Through 6 months
Change in HbA1c
Tidsramme: Baseline, 3 months, and 6 months
Mean change in HbA1c percentage points from the initial community pharmacy measurement to the three-month and six-month measurements among participants with GP-confirmed type 2 diabetes.
Baseline, 3 months, and 6 months
Pharmacist-Delivered Services
Tidsramme: Initial visit through 6 months
Number and percentage of participants receiving HbA1c result explanation, dietary counselling, physical activity counselling, diabetes risk-reduction advice, GP referral, dietitian referral, physician contact, or appointment support.
Initial visit through 6 months
Cost per Participant Screened
Tidsramme: Through completion of the screening phase
Total screening costs divided by the number of participants screened. Costs will include test materials, pharmacist time, educational materials, administration, and referral-related resources.
Through completion of the screening phase
Cost per Confirmed Type 2 Diabetes Case
Tidsramme: Through 3 months after the final referral
Total screening and referral costs divided by the number of participants receiving a GP-confirmed diagnosis of type 2 diabetes.
Through 3 months after the final referral

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Universiti Sains Malaysia

Etterforskere

  • Studiestol: Rabia Hussain, RPh, PhD, Universiti Sains Malaysia

Publikasjoner og nyttige lenker

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Generelle publikasjoner

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Antatt)

1. oktober 2026

Primær fullføring (Antatt)

31. mars 2027

Studiet fullført (Antatt)

31. mai 2027

Datoer for studieregistrering

Først innsendt

26. august 2026

Først innsendt som oppfylte QC-kriteriene

26. august 2026

Først lagt ut (Faktiske)

31. august 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

31. august 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

26. august 2026

Sist bekreftet

1. august 2026

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • USM-DSAP-2026-001

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