Diabetes Mellitus, Type 2PREDICT-DMNCT07795918
PREDICT-DM: Community Pharmacy-Based Point-of-Care Testing for Undiagnosed T2DM
An observational study of Diabetes Mellitus, Type 2 and Prediabetic State, run by Universiti Sains Malaysia at 1 site in Jordan.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Diabetes Mellitus, Type 2, Prediabetic State, Prediabetes / Type 2 Diabetes
- How many people
- 480 participants
- Where
- 1 siteJordan
- Study dates
- 1 Oct 2026to 31 May 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Jordan1 site
Khaled Pharmacy
Irbid, Irbid Governorate
Khaled M. Alshorman, MSc, +962795226732, kmssshorman@gmail.com
About this study
Official title: 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:
Read more
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.
Read the detailed description
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.
- 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
- Medical subject headings
- Diabetes Mellitus, Type 2, Prediabetic State
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Initial community pharmacy visit on Day 0
Secondary outcomes (7)
General Practitioner Referral Completion Rate
Number and percentage of participants with abnormal pharmacy HbA1c results who attend a general practitioner or primary care facility and complete confirmatory assessment.
Measured: Within 3 months after referral
General Practitioner-Confirmed Type 2 Diabetes Diagnosis Rate
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.
Measured: Within 3 months after referral
Treatment Initiation After Confirmed Type 2 Diabetes
Number and percentage of participants with GP-confirmed type 2 diabetes who initiate lifestyle management, oral medication, insulin, or combination treatment.
Measured: Through 6 months
Change in HbA1c
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.
Measured: Baseline, 3 months, and 6 months
Pharmacist-Delivered Services
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.
Measured: Initial visit through 6 months
Cost per Participant Screened
Total screening costs divided by the number of participants screened. Costs will include test materials, pharmacist time, educational materials, administration, and referral-related resources.
Measured: Through completion of the screening phase
Cost per Confirmed Type 2 Diabetes Case
Total screening and referral costs divided by the number of participants receiving a GP-confirmed diagnosis of type 2 diabetes.
Measured: Through 3 months after the final referral
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2026
- Study start1 Oct 2026 (estimated)
- Primary completion31 Mar 2027 (estimated)
- Study completion31 May 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Diabetes Mellitus, Type 2Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 480 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universiti Sains Malaysia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rabia Hussain, Universiti Sains Malaysia
- Investigators
- Rabia Hussain, RPh, PhD, Study chair, Universiti Sains Malaysia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07795918
- Sponsor's protocol ID
- USM-DSAP-2026-001
- Acronym
- PREDICT-DM
- Status last verified
- Aug 2026
- First submitted
- 26 Aug 2026
- Last updated
- 31 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 41210578Alshorman 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.
PubMed 42038923
Study at a glance
From the registry record, last updated by the sponsor on 31 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PREDICT-DM: Pharmacy-based Rapid Early Detection and Identification of Cases of Type 2 Diabetes Mellitus
- ClinicalTrials.gov ID
- NCT07795918
- Acronym / sponsor ID
- PREDICT-DM / USM-DSAP-2026-001
- Keywords
- Community Pharmacy, Point-of-Care Testing, POCT, HbA1c, Finnish Diabetes Risk Score, FINDRISC, Diabetes Screening, Undiagnosed Diabetes
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 480 participants (estimated)
- Lead sponsor
- Universiti Sains MalaysiaUniversity, hospital or other
- Study start
- 1 Oct 2026 (estimated)
- Primary completion
- 31 Mar 2027 (estimated)
- Study completion
- 31 May 2027 (estimated)
- First posted
- 31 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (7 listed)
- Previous diagnosis of diabetes
- Pregnancy
- Known anemia
- Known hemoglobin disorder
- Blood transfusion within the previous three months
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Distribution of Finnish Diabetes Risk Score Categories
Time frame: 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.
7 secondary outcomes
General Practitioner Referral Completion Rate
Time frame: Within 3 months after referral
General Practitioner-Confirmed Type 2 Diabetes Diagnosis Rate
Time frame: Within 3 months after referral
Treatment Initiation After Confirmed Type 2 Diabetes
Time frame: Through 6 months
Change in HbA1c
Time frame: Baseline, 3 months, and 6 months
Pharmacist-Delivered Services
Time frame: Initial visit through 6 months
Cost per Participant Screened
Time frame: Through completion of the screening phase
Cost per Confirmed Type 2 Diabetes Case
Time frame: Through 3 months after the final referral
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Aug 2026.
- Background: PubMed 41210578Alshorman 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.
- Background: PubMed 42038923Alshorman 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Rabia Hussain, RPh, PhD study chair
Universiti Sains Malaysia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Diabetes Mellitus, Type 2 and Prediabetic State, run by Universiti Sains Malaysia at 1 site in Jordan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 31 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Jordan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Khaled M. Alshorman, MSc (+962 79 522 6732, kmssshorman@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Distribution of Finnish Diabetes Risk Score Categories (time frame: Initial community pharmacy visit on Day 0). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07795918, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Aug 2026; AzTrials last refreshed its copy on 1 Nov 2026.