PREDICT-DM: Community Pharmacy-Based Point-of-Care Testing for Undiagnosed T2DM (PREDICT-DM)
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:
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.
Обзор исследования
Статус
Подробное описание
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.
Тип исследования
Регистрация (Оцененный)
Контакты и местонахождение
Контакты исследования
- Имя: Khaled M. Alshorman, MSc
- Номер телефона: +962 79 522 6732
- Электронная почта: kmssshorman@gmail.com
Места учебы
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Irbid Governorate
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Irbid, Irbid Governorate, Иордания
- Khaled Pharmacy
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Контакт:
- Khaled M. Alshorman, MSc
- Номер телефона: +962795226732
- Электронная почта: kmssshorman@gmail.com
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Критерии участия
Критерии приемлемости
Возраст, подходящий для обучения
- Взрослый
- Пожилой взрослый
Принимает здоровых добровольцев
Метод выборки
Исследуемая популяция
Описание
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
Учебный план
Как устроено исследование?
Детали дизайна
Когорты и вмешательства
Группа / когорта |
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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.
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Что измеряет исследование?
Первичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
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Distribution of Finnish Diabetes Risk Score Categories
Временное ограничение: Initial community pharmacy visit on Day 0
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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.
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Initial community pharmacy visit on Day 0
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Вторичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
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General Practitioner Referral Completion Rate
Временное ограничение: Within 3 months after referral
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Number and percentage of participants with abnormal pharmacy HbA1c results who attend a general practitioner or primary care facility and complete confirmatory assessment.
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Within 3 months after referral
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General Practitioner-Confirmed Type 2 Diabetes Diagnosis Rate
Временное ограничение: Within 3 months after referral
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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.
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Within 3 months after referral
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Treatment Initiation After Confirmed Type 2 Diabetes
Временное ограничение: Through 6 months
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Number and percentage of participants with GP-confirmed type 2 diabetes who initiate lifestyle management, oral medication, insulin, or combination treatment.
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Through 6 months
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Change in HbA1c
Временное ограничение: Baseline, 3 months, and 6 months
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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.
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Baseline, 3 months, and 6 months
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Pharmacist-Delivered Services
Временное ограничение: Initial visit through 6 months
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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.
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Initial visit through 6 months
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Cost per Participant Screened
Временное ограничение: Through completion of the screening phase
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Total screening costs divided by the number of participants screened.
Costs will include test materials, pharmacist time, educational materials, administration, and referral-related resources.
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Through completion of the screening phase
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Cost per Confirmed Type 2 Diabetes Case
Временное ограничение: Through 3 months after the final referral
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Total screening and referral costs divided by the number of participants receiving a GP-confirmed diagnosis of type 2 diabetes.
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Through 3 months after the final referral
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Соавторы и исследователи
Спонсор
Следователи
- Учебный стул: Rabia Hussain, RPh, PhD, Universiti Sains Malaysia
Публикации и полезные ссылки
Общие публикации
- 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.
- 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.
Даты записи исследования
Изучение основных дат
Начало исследования (Оцененный)
Первичное завершение (Оцененный)
Завершение исследования (Оцененный)
Даты регистрации исследования
Первый отправленный
Впервые представлено, что соответствует критериям контроля качества
Первый опубликованный (Действительный)
Обновления учебных записей
Последнее опубликованное обновление (Действительный)
Последнее отправленное обновление, отвечающее критериям контроля качества
Последняя проверка
Дополнительная информация
Термины, связанные с этим исследованием
Ключевые слова
Дополнительные соответствующие термины MeSH
Другие идентификационные номера исследования
- USM-DSAP-2026-001
Планирование данных отдельных участников (IPD)
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