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OpenTrials
Completed

NCT Number: NCT03979768

Risk Assessment of Type 2 Diabetes in Pharmacies

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.

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Key information

Conditions

Age range

45 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Diabetes risk assessment service in Norwegian community pharmacies

Other

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.

Primary outcomes

  1. Number of Participants with undiagnosed type 2 diabetes

    Time frame: 2 months

    Number of Participants with undiagnosed type 2 diabetes

Secondary outcomes

  1. 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)

    Time frame: Baseline

    Find the number of participants with a high risk of developing type 2 diabetes

Sponsors and collaborators

Lead sponsor

University of Bergen

Other

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2017
Study completion
2019
First posted
Jun 7, 2019
Registry last updated
Oct 16, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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