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

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.

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