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

26 augustus 2026 bijgewerkt door: 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.

Studie Overzicht

Toestand

Nog niet aan het werven

Conditie

Gedetailleerde beschrijving

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

Observationeel

Inschrijving (Geschat)

480

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studiecontact

Studie Locaties

  • Jordanië
    • Irbid Governorate
      • Irbid, Irbid Governorate, Jordanië
        • Khaled Pharmacy
        • Contact:

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

  • Volwassen
  • Oudere volwassene

Accepteert gezonde vrijwilligers

Ja

Bemonsteringsmethode

Niet-waarschijnlijkheidssteekproef

Studie Bevolking

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.

Beschrijving

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

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

Cohorten en interventies

Groep / Cohort
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.

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Distribution of Finnish Diabetes Risk Score Categories
Tijdsspanne: 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

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
General Practitioner Referral Completion Rate
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

Universiti Sains Malaysia

Onderzoekers

  • Studie stoel: Rabia Hussain, RPh, PhD, Universiti Sains Malaysia

Publicaties en nuttige links

De persoon die verantwoordelijk is voor het invoeren van informatie over het onderzoek stelt deze publicaties vrijwillig ter beschikking. Dit kan gaan over alles wat met het onderzoek te maken heeft.

Algemene publicaties

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Geschat)

1 oktober 2026

Primaire voltooiing (Geschat)

31 maart 2027

Studie voltooiing (Geschat)

31 mei 2027

Studieregistratiedata

Eerst ingediend

26 augustus 2026

Eerst ingediend dat voldeed aan de QC-criteria

26 augustus 2026

Eerst geplaatst (Werkelijk)

31 augustus 2026

Updates van studierecords

Laatste update geplaatst (Werkelijk)

31 augustus 2026

Laatste update ingediend die voldeed aan QC-criteria

26 augustus 2026

Laatst geverifieerd

1 augustus 2026

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • USM-DSAP-2026-001

Plan Individuele Deelnemersgegevens (IPD)

Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?

NEE

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

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