PREDICT-DM: Community Pharmacy-Based Point-of-Care Testing for Undiagnosed T2DM
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorUniversiti Sains Malaysia
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Aged 18 years or older
Lives in Irbid Governorate, Jordan
Visits a participating community pharmacy
Has not previously been diagnosed with diabetes
Disqualifiers
Previous diagnosis of diabetes
Pregnancy
Known anemia
Known hemoglobin disorder
Trial 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.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
480 Participants
are grouped into 1 trial groupGroup A: Community Pharmacy Visitors Without Diagnosed Diabetes
Trial outcomes
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.
Time frame
Initial community pharmacy visit on Day 0Secondary outcomes
1
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 referral2
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 referral3
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 months4
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 monthsSponsors and contacts
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Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: