Type 2 DiabetesPRODIAPNCT07767331
PRODIAP - Patient-reported Outcomes in General Practice Among People With Type 2 Diabetes
A study testing Use of PRO questionnaire in general practice in people with Type 2 Diabetes, run by University of Aarhus at 1 site in Denmark.
Trial summary
In Denmark, around 327,000 diabetes consultations take place annually in general practice, but these often fail to fully include patients' experiences, values, and needs. Research, mainly among people with type 1 diabetes, suggests that the use of Patient Reported Outcomes (PROs) can enhance patient engagement and… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Type 2 Diabetes
- What is being tested?
- Use of PRO questionnaire in general practice
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,000 participants
- Where
- 1 siteDenmark
- Study dates
- 1 Mar 2026to Feb 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- type 2 diabetes
- able to understand and answer a Danish questionnaire
Who cannot join
- none
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Katrine B Bonnén, MSc in Public Health contact
Denmark1 site, 1 recruiting
- Recruiting
Steno Diabetes Center Aarhus
Aarhus, 8200
Anette Andersen, MD, PhD, +4522135605, anette.andersen@rm.dk
About this study
Official title: PRODIAP - Patient-Reported Outcomes in General Practice Among People With Type 2 Diabetes
In Denmark, around 327,000 diabetes consultations take place annually in general practice, but these often fail to fully include patients' experiences, values, and needs. Research, mainly among people with type 1 diabetes, suggests that the use of Patient Reported Outcomes (PROs) can enhance patient engagement and consultation quality. Yet, little is known about the effect of using PROs in type 2 diabetes (T2D) care in general practice. This project, PRODIAP (Patient-reported outcomes in general practice among people with type 2 diabetes) aims to investigate whether the use of a diabetes-specific PRO questionnaire can improve care quality and support more individualised consultations for people with T2D. PRODIAP is tailored to general practice, adapted from hospital PRO tools, and pilot testing showed promising feasibility and acceptability.
This project applies a mixed-methods design with two sub-studies:
Read more
- A pragmatic, cluster-randomised controlled trial in 30 general practices (N≈2000 patients) evaluating PRODIAP's effect on perceived care quality with patient perceived quality of care (PACIC) as primary outcome.
- A qualitative study using observations and interviews to explore how PRODIAP shapes the consultation from both patient and professional perspectives.
The project group has established a national collaboration with general practitioners, researchers and stakeholders from all five Danish region, supporting the feasibility of this study. Findings are expected to improve diabetes care in general practice and inform management of other chronic conditions. Findings are expected to improve diabetes care in general practice and provide transferable knowledge for other chronic conditions.
- Conditions
- Type 2 Diabetes
- Being tested
- Use of PRO questionnaire in general practice
- Keywords
- Patient Reported Outcome (PRO), General Practice (GP), Randomised controlled trial
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Use of PRO questionnaire in general practiceBehavioural
Participants are people with type 2 diabetes, receiving treatment in GP. 30 GPs will be recruited from the Regions of Central Jutland, Zealand, and Southern Denmark, and from here, about 2,000 people (+18) with T2D are recruited. The 30 participating GPs will be randomly assigned to either the intervention (15 GPs) or control (15 GPs) group. The annual consultations in the intervention group will be based on responses to a diabetes-specific PRO questionnaire (PRODIAP) from the persons with T2D, while the control group will follow the usual process without PRODIAP.
| Study group | Role | What they receive |
|---|---|---|
| Type 2 diabetes patients_intervention | Experimental | Patients with type 2 diabetes in general practices randomised to the intervention group will answer a diabetes-specific PRO questionnaire (PRODIAP) in the annual consultations Receives: Behavioral: Use of PRO questionnaire in general practice |
| Type 2 diabetes patients_control | No intervention | Patients in general practices randomised to the control group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient Assessment Chronic Illness Care (PACIC)
Patient Assessment of Chronic Illness Care (PACIC) assesses patient-perceived quality of care among individuals with T2D. PACIC consists of 20 items divided into five subscales with the following themes: patient activation, decision support, goal setting, problem-solving, and coordination/follow-up. PACIC is scored on a 5-point scale ranging from 1 (never) to 5 (always). The total PACIC score is calculated as the mean of all items and as the mean of the five subscales
Measured: "Baseline" - up to 2 weeks before the patients attend their yearly check-up at the general practitioner at year 1 "Endpoint" - up to 2 weeks after the patients attended their yearly check-up at the general practitioner at year 2
Secondary outcomes (1)
Hemoglobin A1C (HbA1c)
Average level of blood glucose over the past two to three months. Collected from laboratory data base
Measured: "Baseline" - up to 2 weeks before the patients attend their yearly check-up at the general practitioner at year 1 "Endpoint" - up to 2 weeks after the patients attended their yearly check-up at the general practitioner at year 2
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Aug 2026
- Study start1 Mar 2026
- Primary completionFeb 2028 (estimated)
- Study completionFeb 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 DiabetesStudies of the same condition, open and under way.
- More trials run by University of AarhusThe sponsor's other registered studies.
- 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 2,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Aarhus
- Sponsor type
- University, hospital or other
- Collaborators
- Steno Diabetes Center Odense, Steno Diabetes Center Sjaelland, Aarhus University Hospital
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07767331
- Sponsor's protocol ID
- PRODIAP
- Acronym
- PRODIAP
- Status last verified
- Dec 2025
- First submitted
- 4 Dec 2025
- Last updated
- 17 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 17 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PRODIAP - Patient-Reported Outcomes in General Practice Among People With Type 2 Diabetes
- ClinicalTrials.gov ID
- NCT07767331
- Acronym / sponsor ID
- PRODIAP / PRODIAP
- Conditions
- Type 2 Diabetes
- Keywords
- Patient Reported Outcome (PRO), General Practice (GP), Randomised controlled trial
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 2,000 participants (estimated)
- Lead sponsor
- University of AarhusUniversity, hospital or other
- Collaborators
- Steno Diabetes Center Odense, Steno Diabetes Center Sjaelland, Aarhus University Hospital
- Study start
- 1 Mar 2026 (actual)
- Primary completion
- Feb 2028 (estimated)
- Study completion
- Feb 2028 (estimated)
- First posted
- 17 Aug 2026 (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.
In Denmark, around 327,000 diabetes consultations take place annually in general practice, but these often fail to fully include patients' experiences, values, and needs. Research, mainly among people with type 1 diabetes, suggests that the use of Patient Reported Outcomes (PROs) can enhance patient engagement and consultation quality. Yet, little is known about the effect of using PROs in type 2 diabetes (T2D) care in general practice. This project, PRODIAP (Patient-reported outcomes in general practice among people with type 2 diabetes) aims to investigate whether the use of a diabetes-specific PRO questionnaire can improve care quality and support more individualised consultations for people with T2D. PRODIAP is tailored to general practice, adapted from hospital PRO tools, and pilot testing showed promising feasibility and acceptability.
This project applies a mixed-methods design with two sub-studies:
- A pragmatic, cluster-randomised controlled trial in 30 general practices (N≈2000 patients) evaluating PRODIAP's effect on perceived care quality with patient perceived quality of care (PACIC) as primary outcome.
- A qualitative study using observations and interviews to explore how PRODIAP shapes the consultation from both patient and professional perspectives.
The project group has established a national collaboration with general practitioners, researchers and stakeholders from all five Danish region, supporting the feasibility of this study. Findings are expected to improve diabetes care in general practice and inform management of other chronic conditions. Findings are expected to improve diabetes care in general practice and provide transferable knowledge for other chronic conditions.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Type 2 diabetes patients_intervention | Experimental | Behavioral: Use of PRO questionnaire in general practicePatients with type 2 diabetes in general practices randomised to the intervention group will answer a diabetes-specific PRO questionnaire (PRODIAP) in the annual consultations |
| Type 2 diabetes patients_control | No intervention | –Patients in general practices randomised to the control group |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- type 2 diabetes
- able to understand and answer a Danish questionnaire
Key exclusion criteria (1 listed)
- none
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 |
|---|---|---|
| Use of PRO questionnaire in general practiceParticipants are people with type 2 diabetes, receiving treatment in GP. 30 GPs will be recruited from the Regions of Central Jutland, Zealand, and Southern Denmark, and from here, about 2,000 people (+18) with T2D are recruited. The 30 participating GPs will be randomly assigned to either the intervention (15 GPs) or control (15 GPs) group. The annual consultations in the intervention group will be based on responses to a diabetes-specific PRO questionnaire (PRODIAP) from the persons with T2D, while the control group will follow the usual process without PRODIAP. | Behavioural | Type 2 diabetes patients_intervention |
Primary outcome
Patient Assessment Chronic Illness Care (PACIC)
Time frame: "Baseline" - up to 2 weeks before the patients attend their yearly check-up at the general practitioner at year 1 "Endpoint" - up to 2 weeks after the patients attended their yearly check-up at the general practitioner at year 2
Patient Assessment of Chronic Illness Care (PACIC) assesses patient-perceived quality of care among individuals with T2D. PACIC consists of 20 items divided into five subscales with the following themes: patient activation, decision support, goal setting, problem-solving, and coordination/follow-up. PACIC is scored on a 5-point scale ranging from 1 (never) to 5 (always). The total PACIC score is calculated as the mean of all items and as the mean of the five subscales
1 secondary outcome
Hemoglobin A1C (HbA1c)
Time frame: "Baseline" - up to 2 weeks before the patients attend their yearly check-up at the general practitioner at year 1 "Endpoint" - up to 2 weeks after the patients attended their yearly check-up at the general practitioner at year 2
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Aug 2026.
- Individual participant dataSharing planned: Undecided
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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.
Katrine B Bonnén, MSc in Public Health contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Use of PRO questionnaire in general practice in people with Type 2 Diabetes, run by University of Aarhus at 1 site in Denmark.
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 2 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: looking for participants now, as of the sponsor's last update on 17 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Anette Andersen, MD, PhD (+4522135605, anette.andersen@rm.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient Assessment Chronic Illness Care (PACIC) (time frame: "Baseline" - up to 2 weeks before the patients attend their yearly check-up at the general practitioner at year 1 "Endpoint" - up to 2 weeks after the patients attended their yearly check-up at the general practitioner at year 2). 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 17 Aug 2026.