Type2 DiabetesNCT03979768
Risk Assessment of Type 2 Diabetes in Pharmacies
A study testing Diabetes risk assessment service in Norwegian community pharmacies in people with Type2 Diabetes, run by University of Bergen.
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. Read more about this study
- Who is it for?
- Ages 45 years and olderHealthy volunteers can take part
- Conditions the study is for
- Type2 Diabetes
- What is being tested?
- Diabetes risk assessment service in Norwegian community pharmacies
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 368 participants
- Where
- No sites listed yet
- Study dates
- 15 Sep 2016to 30 May 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- known diabetes, pregnancy and blood diseases that may affect measurement of Haemoglobin A1c (HbA1c).
About this study
Official title: Risk Assessment and HaemoglobinA1c (HbA1c) -Measurement in Community Pharmacies to Identify People With Undiagnosed Type 2 Diabetes
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.
Read the 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.
- Conditions
- Type2 Diabetes
- Being tested
- Diabetes risk assessment service in Norwegian community pharmacies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Diabetes risk assessment service in Norwegian community pharmaciesOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Risk Assessment Only pharmacies (RTO-group) | Experimental | Offered a diabetes risk assessment service without any blood sample testing. Receives: Other: Diabetes risk assessment service in Norwegian community pharmacies |
| HbA1c-group /pharmacies | Experimental | Offered a diabetes risk assessment service including a measurement of Haemoglobin A1c (HbA1c) to the people with a high risk of developing type 2 diabetes on the risk assessment form (The Finnish Diabetes Risc Score (FINDRISC) to those with a western background, and Leicester Risk Assessment (LRA) form for those with a non-western background. Receives: Other: Diabetes risk assessment service in Norwegian community pharmacies |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants with undiagnosed type 2 diabetes
Number of Participants with undiagnosed type 2 diabetes
Measured: 2 months
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)
Find the number of participants with a high risk of developing type 2 diabetes
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jun 2019
- Study start15 Sep 2016
- Primary completion30 Jun 2017
- Study completion30 May 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type2 DiabetesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Eight community pharmacies offered a diabetes risk assessment including a diabetes risk assessment test only, while 11 community pharmacies
- Masking
- None (open label)
- Enrolment
- 368 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Bergen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Aslaug Johanne Risøy, PhDCandidate, Principal investigator, University of Bergen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03979768
- Sponsor's protocol ID
- 2016/808
- Status last verified
- Oct 2019
- First submitted
- 22 Mar 2019
- Last updated
- 16 Oct 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Risk Assessment and HaemoglobinA1c (HbA1c) -Measurement in Community Pharmacies to Identify People With Undiagnosed Type 2 Diabetes
- ClinicalTrials.gov ID
- NCT03979768
- Acronym / sponsor ID
- 2016/808
- Conditions
- Type2 Diabetes
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 368 participants (actual)
- Lead sponsor
- University of BergenUniversity, hospital or other
- Study start
- 15 Sep 2016 (actual)
- Primary completion
- 30 Jun 2017 (actual)
- Study completion
- 30 May 2019 (actual)
- First posted
- 7 Jun 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Eight community pharmacies offered a diabetes risk assessment including a diabetes risk assessment test only, while 11 community pharmacies
| Arm | Type | Receives |
|---|---|---|
| Risk Assessment Only pharmacies (RTO-group) | Experimental | Other: Diabetes risk assessment service in Norwegian community pharmaciesOffered a diabetes risk assessment service without any blood sample testing. |
| HbA1c-group /pharmacies | Experimental | Other: Diabetes risk assessment service in Norwegian community pharmaciesOffered a diabetes risk assessment service including a measurement of Haemoglobin A1c (HbA1c) to the people with a high risk of developing type 2 diabetes on the risk assessment form (The Finnish Diabetes Risc Score (FINDRISC) to those with a western background, and Leicester Risk Assessment (LRA) form for those with a non-western background. |
Who may qualify
- Ages
- 45 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- known diabetes, pregnancy and blood diseases that may affect measurement of Haemoglobin A1c (HbA1c).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Diabetes risk assessment service in Norwegian community pharmaciesTwo 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. | Other | HbA1c-group /pharmacies, Risk Assessment Only pharmacies (RTO-group) |
Primary outcome
Number of Participants with undiagnosed type 2 diabetes
Time frame: 2 months
Number of Participants with undiagnosed type 2 diabetes
1 secondary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Oct 2019.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Aslaug Johanne Risøy, PhDCandidate principal investigator
University of Bergen
Questions about this trial
What is this clinical trial studying?
A study testing Diabetes risk assessment service in Norwegian community pharmacies in people with Type2 Diabetes, run by University of Bergen.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants with undiagnosed type 2 diabetes (time frame: 2 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Oct 2019.