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Risk Assessment of Type 2 Diabetes in Pharmacies

Risk Assessment and HaemoglobinA1c (HbA1c) -Measurement in Community Pharmacies to Identify People With Undiagnosed Type 2 Diabetes

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03979768
Enrollment
368
Registered
2019-06-07
Start date
2016-09-15
Completion date
2019-05-30
Last updated
2019-10-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Type2 Diabetes

Brief summary

Background: Due to lack of clear symptoms, type 2 diabetes can remain undetected for many years. Our aim was to explore the capacity of Norwegian community pharmacies to identify people at high risk of developing type 2 diabetes and the impact of the risk assessment service on self-rated health. Methods: Nineteen community pharmacies were randomly allocated to a diabetes risk test only- group or Haemoglobin A1c (HbA1c) -group were the participants with a high risk of developing type 2 diabetes also received a HbA1c-measurement. Two pharmacists at each pharmacy were trained to perform risk assessments and counselling. The pharmacists at the 11 HbA1c pharmacies were also trained in how to perform the HbA1c- measurement. During six months, pharmacy customers equal or over 45 years old, wishing to participate contacted the pharmacy staff. Participants completed a validated diabetes risk test and a background questionnaire including a validated instrument for self-rated health. In the risk test only-group, participants with a high risk of developing type 2 diabetes were referred to their general practitioner for follow-up, while in the HbA1c-group, participants with HbA1c ≥ 48 mmol/ mol (6.5%) were referred to their general practitioner.

Detailed description

Background: Due to lack of clear symptoms, type 2 diabetes can remain undetected for many years. Our aim was to explore the capacity of Norwegian community pharmacies to identify people at high risk of developing type 2 diabetes and the impact of the risk assessment service on self-rated health. Methods: Nineteen community pharmacies were randomly allocated to a diabetes risk test only- group or Haemoglobin A1c (HbA1c) -group were the participants with a high risk of developing type 2 diabetes also received a HbA1c-measurement. Two pharmacists at each pharmacy were trained to perform risk assessments and counselling. The pharmacists at the 11 HbA1c pharmacies were also trained in how to perform the HbA1c- measurement. During six months, pharmacy customers equal or above 45 years old, wishing to participate contacted the pharmacy staff. Participants completed a validated diabetes risk test and a background questionnaire including a validated instrument for self-rated health. In the risk test only-group, participants with a high risk of developing type 2 diabetes were referred to their general practitioner for follow-up, while in the HbA1c-group, participants with HbA1c ≥ 48 mmol/ mol (6.5%) were referred to their general practitioner.

Interventions

OTHERDiabetes risk assessment service in Norwegian community pharmacies

Two pharmacists at each pharmacy were trained to perform risk assessments and counselling. During six months, pharmacy customers equal or above 45 years old, wishing to participate contacted the pharmacy staff. Participants completed a validated diabetes risk test and a background questionnaire including a validated instrument for self-rated health.

Sponsors

University of Bergen
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE

Intervention model description

Eight community pharmacies offered a diabetes risk assessment including a diabetes risk assessment test only, while 11 community pharmacies

Eligibility

Sex/Gender
ALL
Age
45 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

\- age equal to or above 45 years old (increased from 18 years in the feasibility study), and being able to read and write Norwegian/English.

Exclusion criteria

\- known diabetes, pregnancy and blood diseases that may affect measurement of Haemoglobin A1c (HbA1c).

Design outcomes

Primary

MeasureTime frameDescription
Number of Participants with undiagnosed type 2 diabetes2 monthsNumber of Participants with undiagnosed type 2 diabetes

Secondary

MeasureTime frameDescription
Explore if there was any difference in the number of participants with a high risk of developing type 2 diabetes in the risk test only (RTO)- group and the group that also offered a HbA1c-measurement (HbA1c-group)BaselineFind the number of participants with a high risk of developing type 2 diabetes

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026