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

NCT07795918 | Not Yet Recruiting

• 1 other identifier: USM-DSAP-2026-001
• Study Type: observational
• Target: 480
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Diabetes Mellitus, Type 2; Prediabetic State; Prediabetes / Type 2 Diabetes; T2DM

Keywords

Community Pharmacy; Point-of-Care Testing; POCT; HbA1c; Finnish Diabetes Risk Score; FINDRISC; Diabetes Screening; Undiagnosed Diabetes; Early Detection; Pharmacist-Led Screening; Jordan; PREDICT-DM

Outcome Measures

Primary Outcomes (1)

• Distribution of Finnish Diabetes Risk Score Categories

  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

Secondary Outcomes (7)

• General Practitioner Referral Completion Rate

  Within 3 months after referral

• General Practitioner-Confirmed Type 2 Diabetes Diagnosis Rate

  Within 3 months after referral

• Treatment Initiation After Confirmed Type 2 Diabetes

  Through 6 months

• Change in HbA1c

  Baseline, 3 months, and 6 months

• Pharmacist-Delivered Services

  Initial visit through 6 months

Study Arms (1)

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Universiti Sains Malaysia: lead

Study Sites (1)

Khaled Pharmacy

Irbid, Irbid Governorate, Jordan

Location

Related Publications (2)

• 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.

  PMID: 41210578 BACKGROUND

• 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.

  PMID: 42038923 BACKGROUND

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Prediabetic State

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Rabia Hussain, RPh, PhD

  Universiti Sains Malaysia

  STUDY CHAIR

Central Study Contacts

Khaled M. Alshorman, MSc

CONTACT

+962 79 522 6732; kmssshorman@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr Rabia Hussain, RPh, PhD Senior Lecturer Universiti Sains Malaysia

Study Record Dates

• First Submitted: August 26, 2026
• First Posted: August 31, 2026
• Study Start: October 1, 2026
• Primary Completion (Estimated): March 31, 2027
• Study Completion (Estimated): May 31, 2027
• Last Updated: August 31, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share

Locations

JO (1)