PREDICT-DM: Community Pharmacy-Based Point-of-Care Testing for Undiagnosed T2DM (PREDICT-DM)
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.
Descripción general del estudio
Estado
Descripción detallada
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.
Tipo de estudio
Inscripción (Estimado)
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Khaled M. Alshorman, MSc
- Número de teléfono: +962 79 522 6732
- Correo electrónico: kmssshorman@gmail.com
Ubicaciones de estudio
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Irbid Governorate
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Irbid, Irbid Governorate, Jordán
- Khaled Pharmacy
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Contacto:
- Khaled M. Alshorman, MSc
- Número de teléfono: +962795226732
- Correo electrónico: kmssshorman@gmail.com
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
Método de muestreo
Población de estudio
Descripción
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
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
Cohortes e Intervenciones
Grupo / Cohorte |
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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.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Distribution of Finnish Diabetes Risk Score Categories
Periodo de tiempo: Initial community pharmacy visit on Day 0
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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.
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Initial community pharmacy visit on Day 0
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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General Practitioner Referral Completion Rate
Periodo de tiempo: Within 3 months after referral
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Number and percentage of participants with abnormal pharmacy HbA1c results who attend a general practitioner or primary care facility and complete confirmatory assessment.
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Within 3 months after referral
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General Practitioner-Confirmed Type 2 Diabetes Diagnosis Rate
Periodo de tiempo: Within 3 months after referral
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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.
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Within 3 months after referral
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Treatment Initiation After Confirmed Type 2 Diabetes
Periodo de tiempo: Through 6 months
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Number and percentage of participants with GP-confirmed type 2 diabetes who initiate lifestyle management, oral medication, insulin, or combination treatment.
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Through 6 months
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Change in HbA1c
Periodo de tiempo: Baseline, 3 months, and 6 months
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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.
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Baseline, 3 months, and 6 months
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Pharmacist-Delivered Services
Periodo de tiempo: Initial visit through 6 months
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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.
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Initial visit through 6 months
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Cost per Participant Screened
Periodo de tiempo: Through completion of the screening phase
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Total screening costs divided by the number of participants screened.
Costs will include test materials, pharmacist time, educational materials, administration, and referral-related resources.
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Through completion of the screening phase
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Cost per Confirmed Type 2 Diabetes Case
Periodo de tiempo: Through 3 months after the final referral
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Total screening and referral costs divided by the number of participants receiving a GP-confirmed diagnosis of type 2 diabetes.
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Through 3 months after the final referral
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Silla de estudio: Rabia Hussain, RPh, PhD, Universiti Sains Malaysia
Publicaciones y enlaces útiles
Publicaciones Generales
- Alshorman K, Hussain R. Community pharmacy-led point-of-care testing (POCT): expanding roles and strengthening health systems in low- and middle-income countries (LMICs). J Pharm Policy Pract. 2025 Nov 5;18(1):2578803. doi: 10.1080/20523211.2025.2578803. eCollection 2025.
- Alshorman K, Hussain R. Community pharmacy based point-of-care testing for early detection of undiagnosed type 2 diabetes mellitus: a study protocol. J Pharm Policy Pract. 2026 Apr 22;19(1):2654489. doi: 10.1080/20523211.2026.2654489. eCollection 2026.
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Estimado)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- USM-DSAP-2026-001
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
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