Risk Assessment of Type 2 Diabetes in Pharmacies

Type2 Diabetes Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03979768
• Other study ID #: 2016/808
• Status: Completed
• Phase: N/A
• Start date: September 15, 2016
• Est. completion date: May 30, 2019

Study information

• Verified date: October 2019
• Source: University of Bergen
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 368
• Est. completion date: May 30, 2019
• Est. primary completion date: June 30, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 45 Years and older

Eligibility

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).

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Type2 Diabetes

Intervention

Other:
• Diabetes 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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University of Bergen

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants with undiagnosed type 2 diabetes	Number of Participants with undiagnosed type 2 diabetes	2 months
Secondary	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)	Find the number of participants with a high risk of developing type 2 diabetes	Baseline