An observational study in Diabetes Mellitus, Type 2, Prediabetic State and Prediabetes / Type 2 Diabetes, sponsored by Universiti Sains Malaysia. Not yet recruiting at 1 site in Jordan. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-08-31.
Sponsored by Universiti Sains Malaysia · Observational
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.
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.
10,371 studies on the registry are indexed under Diabetes Mellitus, Type 2; 1,406 are open to participants now.
This study's planned enrollment of 480 is above the median of 300 across 1,741 observational studies indexed under Diabetes Mellitus, Type 2.
Browse Diabetes Mellitus, Type 2 studies →Universiti Sains Malaysia is the lead sponsor of 177 studies on the registry; 51 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hemoglobin (Hb)
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HbA1c
A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
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.
Time frame: Initial community pharmacy visit on Day 0
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Through 3 months after the final referral
Plan to share: No
Start is estimated for Oct 2026; primary completion for Mar 2027, 5 months later.
Of 432 non-industry observational studies under Diabetes Mellitus, Type 2, half reached primary completion within 35 months of starting (the median), counting those still running; a quarter within 17 and three quarters within 96. This study's planned 5 months is below that.
Counting every sponsor, half of 602 studies reached it within 32 months; a quarter within 17 and three quarters within 62.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.