Diabetes Mellitus, Type 2STARNCT05268081
Specialist Conferences Between General Practitioners and Endocrinologists
A study testing Virtual specialist conferences in people with Diabetes Mellitus, Type 2, run by University of Aarhus at 1 site in Denmark.
Trial summary
To support the primary care sector in delivering high-quality Type 2-diabetes (T2D), literature reviews emphasize the need for implementing models of collaboration that in a simple and effective way facilitate clinical dialogue between general practitioners (GPs) and endocrinologists. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Diabetes Mellitus, Type 2
- What is being tested?
- Virtual specialist conferences
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteDenmark
- Study dates
- 1 Jan 2022to 30 Sep 2024
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- General practices are eligible for inclusion if licensed and located in the municipality of Aarhus.
- GPs must consent to participate in the intervention and collect the data needed to measure patient and general practice outcomes.
- GPs must agree to bring patient cases to the virtual conferences who are ≥18 years, diagnosed with T2D and who they would like to discuss with the endocrinologist.
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Virtual Specialist Conferences Between General Practitioners and Endocrinologists About Type 2.Diabetes: a Pragmatic Randomized Controlled Trial
To support the primary care sector in delivering high-quality Type 2-diabetes (T2D), literature reviews emphasize the need for implementing models of collaboration that in a simple and effective way facilitate clinical dialogue between general practitioners (GPs) and endocrinologists. The overall aim of the project is to study if an intervention consisting of structured cross-sectoral and virtual conferences between GPs and endocrinologists about T2D improves diabetes care and increases diabetes competencies and management in general practice. This aim will be studied in a pragmatic randomized controlled trial design. This potential is yet to be fully tapped because of methodological limitations. Studies have also not yet systematically evaluated virtual conferences in the context of chronic care using a high-quality research design.
Read the detailed description
The overall aim is to study if cross-sectoral and virtual specialist conferences improves diabetes care and increases diabetes competencies and management in general practice. The expectation is that the intervention will:
at the patient level:
- improve adherence to international recommendations on diabetes medication for patients with Type 2-diabetes (T2D)
- improve the risk profile of patients with T2D with a reduction in glycated haemoglobin, blood pressure and cholesterol at the general practice level:
- improve the self-reported competence and confidence in management of patients with T2D among general practitioners and practice staff
The intervention consists of four virtual and thematic conferences: (1) T2D and cardiovascular disease and heart failure, (2) T2D and lipids, (3) T2D and kidney disease and blood pressure, and (4) T2D and a free topic selected by the general practitioner (GP). Before having the first virtual conference, an introductory webinar is held to learn GPs about how to use the electronic "Diabetes Overview" to identify and manage patients with T2D. Each general practice is assigned to an endocrinologist who they meet at all four conferences. The intervention was developed using the Medical Research Framework for developing complex interventions.
All general practices located in the Municipality of Aarhus, Denmark are invited (n = 100). Block randomization is performed at the general practice level, and general practices will be randomized in a 1:1 ratio to either the intervention or the control group.
- Conditions
- Diabetes Mellitus, Type 2
- Being tested
- Virtual specialist conferences
- Keywords
- Specialist conferences, Virtual conferences, Family physician, Endocrinologist, Type 2-diabetes, Randomized 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.
Virtual specialist conferencesOther
The intervention consists of four virtual conferences (45 min each in month 2, 5, 8 and 11) and an introductory webinar (90 min in month 1) to learn GPs about how to use the electronic "Diabetes Overview" to identify and manage patients with T2D. Each general practice is assigned to one specific endocrinologist they meet with throughout. The four virtual conferences are thematic: T2D and cardiovascular disease and heart failure, T2D and lipids, T2D and kidney disease and blood pressure, and T2D and a free topic selected by the GP. At each conference, the GP must bring 2-3 patient cases related to the theme and 1-2 patients of their own choice. The GP chairs the meeting. Each conference follows the same format: Check in (5 min); Short presentation by the endocrinologist (10 min); Presentation by GP and joint dialogue about theme-related patients (20 min); Presentation by GP and joint dialogue about theme-unrelated patients (optional, 5 min); (5) Wrapping-up (5 min).
| Study group | Role | What they receive |
|---|---|---|
| Virtual specialist conferences | Experimental | The group of general practices who participates in the virtual specialist conferences with endocrinologists. Receives: Other: Virtual specialist conferences |
| Standard of care | No intervention | Receives the usual, standard practice. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ischemic heart disease and/or stroke treated with GLP1-RA and SGLT2 inhibitor
Percentage of patients with type 2-diabetes and ischemic heart disease and/or stroke being treated with glucagon-like peptide 1 receptor agonists (GLP1-RA) and sodium glucose cotransporter 2 (SGLT2) inhibitor
Measured: Month 12
Micro/macro-albuminuria treated with ACE-inhibitor or AT2
Percentage of patients with type 2-diabetes and micro/macro-albuminuria being treated with Angiotensin-converting-enzyme-inhibitor (ACE) or angiotensin-2-receptorantagonist (AT2)
Measured: Month 12
LDL>2.5 mmol/L treated with Statins
Percentage of patients with type 2-diabetes and LDL>2.5 mmol/L being treated with Statins
Measured: Month 12
Questionnaire for the assessment of general practitioners' confidence in managing type-2 diabetes in general
Self-reported degree to which the general practitioner is confident in: managing diabetes; managing patients with diabetes; managing patients with complex diabetes; managing patients with diabetes who are non-compliant.
Range 1-5 from "not at all" to "a very high degree", higher score indicates higher confidence.
Measured: Month 12
Questionnaire for the assessment of general practitioners' skills in managing type-2 diabetes in general
Self-reported degree to which the general practitioner is confident in: assessing when it is appropriate to initiate insulin treatment; selecting the appropriate medicine, when patients with diabetes need three-agent antidiabetics; selecting the appropriate medicine, when patients with have co-morbidity; achieving a lower level of Hb1Ac in patients with diabetes; high treatment quality for patients with diabetes; setting treatment targets for patients with diabetes; referring the right patients with diabetes to the department of endocrinology.
Range 1-5 from "not at all" to "a very high degree", higher score indicates higher confidence.
Measured: Month 12
Questionnaire for the assessment of general practitioners' confidence in managing type-2 diabetes and cardiovascular disease or heart failure
Self-reported degree to which the general practitioner is confident in: managing cardiovascular disease in patients with diabetes; assessing risk of cardiovascular disease in patients with diabetes; selecting the most appropriate medication for patients with diabetes and cardiovascular disease; achieving high treatment quality for patients with diabetes and cardiovascular disease; managing heart failure in patients with diabetes; assessing risk of heart failure in patients with diabetes; selecting the most appropriate medication for patients with diabetes and heart failure; achieving high treatment quality for patients with diabetes and heart failure.
Range 1-5 from "not at all" to "a very high degree", higher score indicates higher confidence.
Measured: Month 12
Questionnaire for the assessment of general practitioners' confidence in managing type-2 diabetes and blood pressure
Self-reported degree to which the general practitioner is confident in: managing high blood pressure in patients with diabetes; selecting the most appropriate medication for patients with diabetes and high blood pressure; achieving high treatment quality for patients with diabetes and high blood pressure.
Range 1-5 from "not at all" to "a very high degree", higher score indicates higher confidence.
Measured: Month 12
Questionnaire for the assessment of general practitioners' confidence in managing type-2 diabetes and kidney disease
Self-reported degree to which the general practitioner is confident in: managing kidney disease in patients with diabetes; managing Estimated Glomerular Filtration Rate (eGFR) in patients with diabetes; managing albuminuria in patients with diabetes; selecting the most appropriate medication for patients with diabetes if they have kidney disease in the form of lowered eGFR; selecting the most appropriate medication for patients with diabetes if they have kidney disease in the form of albuminuria; achieving high treatment quality for patients with diabetes and kidney disease.
Range 1-5 from "not at all" to "a very high degree", higher score indicates higher confidence.
Measured: Month 12
Questionnaire for the assessment of general practitioners' confidence in managing type-2 diabetes and cholesterol
Self-reported degree to which the general practitioner is confident in: managing high cholesterol in patients with diabetes; selecting the most appropriate cholesterol lowering medication for patients with diabetes; achieving a lower level of cholesterol among patients with diabetes and high cholesterol.
Range 1-5 from "not at all" to "a very high degree", higher score indicates higher confidence.
Measured: Month 12
Secondary outcomes (26)
Ischemic heart disease and/or stroke treated with GLP1-RA and SGLT2 inhibitor
Percentage of patients with type 2-diabetes and ischemic heart disease and/or stroke being treated with glucagon-like peptide 1 receptor agonists (GLP1-RA) and sodium glucose cotransporter 2 (SGLT2) inhibitor
Measured: Month 24
Micro/macro-albuminuria treated with ACE-inhibitor or AT2
Percentage of patients with type 2-diabetes and micro/macro-albuminuria being treated with Angiotensin-converting-enzyme-inhibitor (ACE) or angiotensin-2-receptorantagonist (AT2)
Measured: Month 24
LDL>2.5 mmol/L treated with Statins
Percentage of patients with type 2-diabetes and LDL>2.5 mmol/L being treated with Statins
Measured: Month 24
Questionnaire for the assessment of general practitioners' confidence in managing type-2 diabetes in general at 24 month
Self-reported degree to which the general practitioner is confident in: managing diabetes; managing patients with diabetes; managing patients with complex diabetes; managing patients with diabetes who are non-compliant.
Range 1-5 from "not at all" to "a very high degree", higher score indicates higher confidence.
Measured: Month 24
Questionnaire for the assessment of general practitioners' skills in managing type-2 diabetes in general at 24 month
Self-reported degree to which the general practitioner is confident in: assessing when it is appropriate to initiate insulin treatment; selecting the appropriate medicine, when patients with diabetes need three-agent antidiabetics; selecting the appropriate medicine, when patients with have co-morbidity; achieving a lower level of Hb1Ac in patients with diabetes; high treatment quality for patients with diabetes; setting treatment targets for patients with diabetes; referring the right patients with diabetes to the department of endocrinology.
Range 1-5 from "not at all" to "a very high degree", higher score indicates higher confidence.
Measured: Month 24
Questionnaire for the assessment of general practitioners' confidence in managing type-2 diabetes and cardiovascular disease or heart failure at 24 month
Self-reported degree to which the general practitioner is confident in: managing cardiovascular disease in patients with diabetes; assessing risk of cardiovascular disease in patients with diabetes; selecting the most appropriate medication for patients with diabetes and cardiovascular disease; achieving high treatment quality for patients with diabetes and cardiovascular disease; managing heart failure in patients with diabetes; assessing risk of heart failure in patients with diabetes; selecting the most appropriate medication for patients with diabetes and heart failure; achieving high treatment quality for patients with diabetes and heart failure.
Range 1-5 from "not at all" to "a very high degree", higher score indicates higher confidence.
Measured: Month 24
Questionnaire for the assessment of general practitioners' confidence in managing type-2 diabetes and blood pressure at 24 month
Self-reported degree to which the general practitioner is confident in: managing high blood pressure in patients with diabetes; selecting the most appropriate medication for patients with diabetes and high blood pressure; achieving high treatment quality for patients with diabetes and high blood pressure.
Range 1-5 from "not at all" to "a very high degree", higher score indicates higher confidence.
Measured: Month 24
Questionnaire for the assessment of general practitioners' confidence in managing type-2 diabetes and kidney disease at 24 month
Self-reported degree to which the general practitioner is confident in: managing kidney disease in patients with diabetes; managing Estimated Glomerular Filtration Rate (eGFR) in patients with diabetes; managing albuminuria in patients with diabetes; selecting the most appropriate medication for patients with diabetes if they have kidney disease in the form of lowered eGFR; selecting the most appropriate medication for patients with diabetes if they have kidney disease in the form of albuminuria; achieving high treatment quality for patients with diabetes and kidney disease.
Range 1-5 from "not at all" to "a very high degree", higher score indicates higher confidence.
Measured: Month 24
Questionnaire for the assessment of general practitioners' confidence in managing type-2 diabetes and cholesterol at 24 month
Self-reported degree to which the general practitioner is confident in: managing high cholesterol in patients with diabetes; selecting the most appropriate cholesterol lowering medication for patients with diabetes; achieving a lower level of cholesterol among patients with diabetes and high cholesterol.
Range 1-5 from "not at all" to "a very high degree", higher score indicates higher confidence.
Measured: Month 24
Patients with T2D and HbA1c <58 mmol/L at 12 and 24 months
Percentage of patients with type 2-diabetes and HbA1c <58 mmol/L
Measured: Month 12 and Month 24
Patients with T2D and HbA1c <53 mmol/L at 12 and 24 months
Percentage of patients with type 2-diabetes and HbA1c <53 mmol/L
Measured: Month 12 and Month 24
Patients with T2D and blood pressure <140 mmHg at 12 and 24 months
Percentage of patients with type 2-diabetes and blood pressure <140 mmHg
Measured: Month 12 and Month 24
Patients with T2D and blood pressure <130 mmHg at 12 and 24 months
Percentage of patients with type 2-diabetes and blood pressure <130 mmHg
Measured: Month 12 and Month 24
Patients with T2D and LDL >2.5 mmol/L at 12 and 24 months
Percentage of patients with type 2-diabetes and low-density lipoprotein >2.5 mmol/L
Measured: Month 12 and Month 24
Patients with T2D and microalbuminuria and LDL >1.8 mmol/L at 12 and 24 months
Percentage of patients with type 2-diabetes and microalbuminuria and LDL >1.8 mmol/L
Measured: Month 12 and Month 24
Questionnaire for the assessment of general practitioners' rating of relational coordination in the general practice at 12 and 24 months
Self-reported assessment by the general practitioner about their collaboration with the general practice using the relational coordination survey that measures the degree of: Frequent Communication; Timely Communication; Accurate Communication; Problem Solving Communication; Shared Goals; Shared Knowledge; Mutual Respect.
Range 1-5, higher score indicates relational coordination.
Measured: Month 12 and Month 24
Questionnaire for the assessment of general practitioners' rating of relational coordination with the hospital at 12 and 24 months
Self-reported assessment by the general practitioner about their collaboration with the hospital using the relational coordination survey that measures the degree of: Frequent Communication; Timely Communication; Accurate Communication; Problem Solving Communication; Shared Goals; Shared Knowledge; Mutual Respect.
Range 1-5, higher score indicates relational coordination.
Measured: Month 12 and Month 24
Questionnaire for the assessment of general practitioners' rating of using virtual conferences at 12 and 24 months
Self-reported assessment by the general practitioner about using virtual conferences measured along the four dimensions of the Technology Acceptance Model: perceived usefulness of virtual conferences; perceived ease-of-use of virtual conferences; attitude to using virtual conferences; behavioural intention as regards using virtual conferences.
Range 1-5 from "completely disagree" to "completely agree", higher score indicates higher user ratings.
Measured: Month 12 and Month 24
Questionnaire for the assessment of practice staffs' rating of relational coordination in the general practice at 12 and 24 months
Self-reported assessment by the practice staff about their collaboration with the general practice using the relational coordination survey that measures the degree of: Frequent Communication; Timely Communication; Accurate Communication; Problem Solving Communication; Shared Goals; Shared Knowledge; Mutual Respect.
Range 1-5, higher score indicates higher relational coordination.
Measured: Month 12 and Month 24
Questionnaire for the assessment of practice staffs' rating of relational coordination with the hospital at 12 and 24 months
Self-reported assessment by the practice staff about their collaboration with the hospital using the relational coordination survey that measures the degree of: Frequent Communication; Timely Communication; Accurate Communication; Problem Solving Communication; Shared Goals; Shared Knowledge; Mutual Respect.
Range 1-5, higher score indicates higher relational coordination.
Measured: Month 12 and Month 24
Questionnaire for the assessment of practice staffs' rating of using virtual conferences at 12 and 24 months
Self-reported assessment by the practice staff about using virtual conferences measured along four dimensions of the Technology Acceptance Model: perceived usefulness of virtual conferences; perceived ease-of-use of virtual conferences; attitude to using virtual conferences; behavioural intention as regards using virtual conferences.
Range 1-5 from "completely disagree" to "completely agree", higher score indicates higher user ratings.
Measured: Month 12 and Month 24
Questionnaire for the assessment of practice staffs' confidence in managing type-2 diabetes in general at 12 and 24 month
Self-reported degree to which the practice staff is confident in: managing diabetes; managing patients with diabetes; managing patients with complex diabetes; managing patients with diabetes who are non-compliant; achieving high treatment quality for patients with diabetes.
Range 1-5 from "not at all" to "a very high degree", higher score indicates higher confidence.
Measured: Month 12 and Month 24
Questionnaire for the assessment of practice staffs' confidence in managing type-2 diabetes and cardiovascular disease or heart failure at 12 and 24 month
Self-reported degree to which the practice staff is confident in: managing cardiovascular disease in patients with diabetes; assessing risk of cardiovascular disease in patients with diabetes; achieving high treatment quality for patients with diabetes and cardiovascular disease; managing heart failure in patients with diabetes; assessing risk of heart failure in patients with diabetes; achieving high treatment quality for patients with diabetes and heart failure.
Range 1-5 from "not at all" to "a very high degree", higher score indicates higher confidence.
Measured: Month 12 and Month 24
Questionnaire for the assessment of practice staffs' confidence in managing type-2 diabetes and blood pressure at 12 and 24 months
Self-reported degree to which the practice staff is confident in: managing high blood pressure in patients with diabetes; achieving high treatment quality for patients with diabetes and high blood pressure.
Range 1-5 from "not at all" to "a very high degree", higher score indicates higher confidence.
Measured: Month 12 and Month 24
Questionnaire for the assessment of practice staffs' confidence in managing type-2 diabetes and kidney disease at 12 and 24 months
Self-reported degree to which the practice staff is confident in: managing kidney disease in patients with diabetes; achieving high treatment quality for patients with diabetes and kidney disease.
Range 1-5 from "not at all" to "a very high degree", higher score indicates higher confidence.
Measured: Month 12 and Month 24
Questionnaire for the assessment of practice staffs' confidence in managing type-2 diabetes and cholesterol at 12 and 24 month
Self-reported degree to which the practice staff is confident in managing high cholesterol in patients with diabetes.
Range 1-5 from "not at all" to "a very high degree", higher score indicates higher confidence.
Measured: Month 12 and Month 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Mar 2022
- Study start1 Jan 2022
- Primary completion30 Aug 2023
- Study completion30 Sep 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Diabetes Mellitus, Type 2Studies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Pragmatic randomized controlled trial
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Aarhus
- Sponsor type
- University, hospital or other
- Collaborators
- Aarhus University Hospital, Region MidtJylland Denmark
- Responsible party
- Sponsor
- Investigators
- Thim Prætorius, PhD, Principal investigator, Aarhus University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05268081
- Sponsor's protocol ID
- 1-30-72-353-21
- Acronym
- STAR
- Status last verified
- Dec 2024
- First submitted
- 31 Jan 2022
- Last updated
- 8 Jan 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Restrictions apply to the availability of these datasets. Register data will be used under license for the current study. Survey data and patient outcomes data are not publicly available as per the written consent signed by general practitioners and endocrinologists. Data are, however, available for research purposes from the authors upon reasonable request and with permission from study participants.
Publications
Praetorius T, Baymler Lundberg AS, Sondergaard E, Tang Knudsen S, Sandbaek A. The effect of virtual specialist conferences between endocrinologists and general practitioners about type 2 diabetes: study protocol for a pragmatic randomized superiority trial. Trials. 2022 Dec 28;23(1):1059. doi: 10.1186/s13063-022-06961-y.
PubMed 36578024Praetorius T, Baymler Lundberg AS, Klausen Fredslund E, Blach Rossen N, Gregersen S, Prior A, Sondergaard E, Tang Knudsen S, Sandbaek A. Effect of video conferencing between primary and secondary care specialists on type 2 diabetes medication. NPJ Digit Med. 2025 Mar 28;8(1):179. doi: 10.1038/s41746-025-01570-w.
PubMed 40148532
Study at a glance
From the registry record, last updated by the sponsor on 8 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Virtual Specialist Conferences Between General Practitioners and Endocrinologists About Type 2.Diabetes: a Pragmatic Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05268081
- Acronym / sponsor ID
- STAR / 1-30-72-353-21
- Conditions
- Diabetes Mellitus, Type 2
- Keywords
- Specialist conferences, Virtual conferences, Family physician, Endocrinologist, Type 2-diabetes, Randomized Controlled Trial
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- University of AarhusUniversity, hospital or other
- Collaborators
- Aarhus University Hospital, Region MidtJylland Denmark
- Study start
- 1 Jan 2022 (actual)
- Primary completion
- 30 Aug 2023 (actual)
- Study completion
- 30 Sep 2024 (actual)
- First posted
- 7 Mar 2022 (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.
To support the primary care sector in delivering high-quality Type 2-diabetes (T2D), literature reviews emphasize the need for implementing models of collaboration that in a simple and effective way facilitate clinical dialogue between general practitioners (GPs) and endocrinologists. The overall aim of the project is to study if an intervention consisting of structured cross-sectoral and virtual conferences between GPs and endocrinologists about T2D improves diabetes care and increases diabetes competencies and management in general practice. This aim will be studied in a pragmatic randomized controlled trial design. This potential is yet to be fully tapped because of methodological limitations. Studies have also not yet systematically evaluated virtual conferences in the context of chronic care using a high-quality research design.
Detailed description
The overall aim is to study if cross-sectoral and virtual specialist conferences improves diabetes care and increases diabetes competencies and management in general practice. The expectation is that the intervention will:
at the patient level:
- improve adherence to international recommendations on diabetes medication for patients with Type 2-diabetes (T2D)
- improve the risk profile of patients with T2D with a reduction in glycated haemoglobin, blood pressure and cholesterol at the general practice level:
- improve the self-reported competence and confidence in management of patients with T2D among general practitioners and practice staff
The intervention consists of four virtual and thematic conferences: (1) T2D and cardiovascular disease and heart failure, (2) T2D and lipids, (3) T2D and kidney disease and blood pressure, and (4) T2D and a free topic selected by the general practitioner (GP). Before having the first virtual conference, an introductory webinar is held to learn GPs about how to use the electronic "Diabetes Overview" to identify and manage patients with T2D. Each general practice is assigned to an endocrinologist who they meet at all four conferences. The intervention was developed using the Medical Research Framework for developing complex interventions.
All general practices located in the Municipality of Aarhus, Denmark are invited (n = 100). Block randomization is performed at the general practice level, and general practices will be randomized in a 1:1 ratio to either the intervention or the control group.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Pragmatic randomized controlled trial
| Arm | Type | Receives |
|---|---|---|
| Virtual specialist conferences | Experimental | Other: Virtual specialist conferencesThe group of general practices who participates in the virtual specialist conferences with endocrinologists. |
| Standard of care | No intervention | –Receives the usual, standard practice. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- General practices are eligible for inclusion if licensed and located in the municipality of Aarhus.
- GPs must consent to participate in the intervention and collect the data needed to measure patient and general practice outcomes.
- GPs must agree to bring patient cases to the virtual conferences who are ≥18 years, diagnosed with T2D and who they would like to discuss with the endocrinologist.
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 |
|---|---|---|
| Virtual specialist conferencesThe intervention consists of four virtual conferences (45 min each in month 2, 5, 8 and 11) and an introductory webinar (90 min in month 1) to learn GPs about how to use the electronic "Diabetes Overview" to identify and manage patients with T2D. Each general practice is assigned to one specific endocrinologist they meet with throughout. The four virtual conferences are thematic: T2D and cardiovascular disease and heart failure, T2D and lipids, T2D and kidney disease and blood pressure, and T2D and a free topic selected by the GP. At each conference, the GP must bring 2-3 patient cases related to the theme and 1-2 patients of their own choice. The GP chairs the meeting. Each conference follows the same format: Check in (5 min); Short presentation by the endocrinologist (10 min); Presentation by GP and joint dialogue about theme-related patients (20 min); Presentation by GP and joint dialogue about theme-unrelated patients (optional, 5 min); (5) Wrapping-up (5 min). | Other | Virtual specialist conferences |
Primary outcome
Ischemic heart disease and/or stroke treated with GLP1-RA and SGLT2 inhibitor
Time frame: Month 12
Percentage of patients with type 2-diabetes and ischemic heart disease and/or stroke being treated with glucagon-like peptide 1 receptor agonists (GLP1-RA) and sodium glucose cotransporter 2 (SGLT2) inhibitor
Micro/macro-albuminuria treated with ACE-inhibitor or AT2
Time frame: Month 12
Percentage of patients with type 2-diabetes and micro/macro-albuminuria being treated with Angiotensin-converting-enzyme-inhibitor (ACE) or angiotensin-2-receptorantagonist (AT2)
LDL>2.5 mmol/L treated with Statins
Time frame: Month 12
Percentage of patients with type 2-diabetes and LDL>2.5 mmol/L being treated with Statins
Questionnaire for the assessment of general practitioners' confidence in managing type-2 diabetes in general
Time frame: Month 12
Self-reported degree to which the general practitioner is confident in: managing diabetes; managing patients with diabetes; managing patients with complex diabetes; managing patients with diabetes who are non-compliant. Range 1-5 from "not at all" to "a very high degree", higher score indicates higher confidence.
Questionnaire for the assessment of general practitioners' skills in managing type-2 diabetes in general
Time frame: Month 12
Self-reported degree to which the general practitioner is confident in: assessing when it is appropriate to initiate insulin treatment; selecting the appropriate medicine, when patients with diabetes need three-agent antidiabetics; selecting the appropriate medicine, when patients with have co-morbidity; achieving a lower level of Hb1Ac in patients with diabetes; high treatment quality for patients with diabetes; setting treatment targets for patients with diabetes; referring the right patients with diabetes to the department of endocrinology. Range 1-5 from "not at all" to "a very high degree", higher score indicates higher confidence.
Questionnaire for the assessment of general practitioners' confidence in managing type-2 diabetes and cardiovascular disease or heart failure
Time frame: Month 12
Self-reported degree to which the general practitioner is confident in: managing cardiovascular disease in patients with diabetes; assessing risk of cardiovascular disease in patients with diabetes; selecting the most appropriate medication for patients with diabetes and cardiovascular disease; achieving high treatment quality for patients with diabetes and cardiovascular disease; managing heart failure in patients with diabetes; assessing risk of heart failure in patients with diabetes; selecting the most appropriate medication for patients with diabetes and heart failure; achieving high treatment quality for patients with diabetes and heart failure. Range 1-5 from "not at all" to "a very high degree", higher score indicates higher confidence.
Questionnaire for the assessment of general practitioners' confidence in managing type-2 diabetes and blood pressure
Time frame: Month 12
Self-reported degree to which the general practitioner is confident in: managing high blood pressure in patients with diabetes; selecting the most appropriate medication for patients with diabetes and high blood pressure; achieving high treatment quality for patients with diabetes and high blood pressure. Range 1-5 from "not at all" to "a very high degree", higher score indicates higher confidence.
Questionnaire for the assessment of general practitioners' confidence in managing type-2 diabetes and kidney disease
Time frame: Month 12
Self-reported degree to which the general practitioner is confident in: managing kidney disease in patients with diabetes; managing Estimated Glomerular Filtration Rate (eGFR) in patients with diabetes; managing albuminuria in patients with diabetes; selecting the most appropriate medication for patients with diabetes if they have kidney disease in the form of lowered eGFR; selecting the most appropriate medication for patients with diabetes if they have kidney disease in the form of albuminuria; achieving high treatment quality for patients with diabetes and kidney disease. Range 1-5 from "not at all" to "a very high degree", higher score indicates higher confidence.
Questionnaire for the assessment of general practitioners' confidence in managing type-2 diabetes and cholesterol
Time frame: Month 12
Self-reported degree to which the general practitioner is confident in: managing high cholesterol in patients with diabetes; selecting the most appropriate cholesterol lowering medication for patients with diabetes; achieving a lower level of cholesterol among patients with diabetes and high cholesterol. Range 1-5 from "not at all" to "a very high degree", higher score indicates higher confidence.
26 secondary outcomes
Ischemic heart disease and/or stroke treated with GLP1-RA and SGLT2 inhibitor
Time frame: Month 24
Micro/macro-albuminuria treated with ACE-inhibitor or AT2
Time frame: Month 24
LDL>2.5 mmol/L treated with Statins
Time frame: Month 24
Questionnaire for the assessment of general practitioners' confidence in managing type-2 diabetes in general at 24 month
Time frame: Month 24
Questionnaire for the assessment of general practitioners' skills in managing type-2 diabetes in general at 24 month
Time frame: Month 24
Questionnaire for the assessment of general practitioners' confidence in managing type-2 diabetes and cardiovascular disease or heart failure at 24 month
Time frame: Month 24
Questionnaire for the assessment of general practitioners' confidence in managing type-2 diabetes and blood pressure at 24 month
Time frame: Month 24
Questionnaire for the assessment of general practitioners' confidence in managing type-2 diabetes and kidney disease at 24 month
Time frame: Month 24
Questionnaire for the assessment of general practitioners' confidence in managing type-2 diabetes and cholesterol at 24 month
Time frame: Month 24
Patients with T2D and HbA1c <58 mmol/L at 12 and 24 months
Time frame: Month 12 and Month 24
Patients with T2D and HbA1c <53 mmol/L at 12 and 24 months
Time frame: Month 12 and Month 24
Patients with T2D and blood pressure <140 mmHg at 12 and 24 months
Time frame: Month 12 and Month 24
Patients with T2D and blood pressure <130 mmHg at 12 and 24 months
Time frame: Month 12 and Month 24
Patients with T2D and LDL >2.5 mmol/L at 12 and 24 months
Time frame: Month 12 and Month 24
Patients with T2D and microalbuminuria and LDL >1.8 mmol/L at 12 and 24 months
Time frame: Month 12 and Month 24
Questionnaire for the assessment of general practitioners' rating of relational coordination in the general practice at 12 and 24 months
Time frame: Month 12 and Month 24
Questionnaire for the assessment of general practitioners' rating of relational coordination with the hospital at 12 and 24 months
Time frame: Month 12 and Month 24
Questionnaire for the assessment of general practitioners' rating of using virtual conferences at 12 and 24 months
Time frame: Month 12 and Month 24
Questionnaire for the assessment of practice staffs' rating of relational coordination in the general practice at 12 and 24 months
Time frame: Month 12 and Month 24
Questionnaire for the assessment of practice staffs' rating of relational coordination with the hospital at 12 and 24 months
Time frame: Month 12 and Month 24
Questionnaire for the assessment of practice staffs' rating of using virtual conferences at 12 and 24 months
Time frame: Month 12 and Month 24
Questionnaire for the assessment of practice staffs' confidence in managing type-2 diabetes in general at 12 and 24 month
Time frame: Month 12 and Month 24
Questionnaire for the assessment of practice staffs' confidence in managing type-2 diabetes and cardiovascular disease or heart failure at 12 and 24 month
Time frame: Month 12 and Month 24
Questionnaire for the assessment of practice staffs' confidence in managing type-2 diabetes and blood pressure at 12 and 24 months
Time frame: Month 12 and Month 24
Questionnaire for the assessment of practice staffs' confidence in managing type-2 diabetes and kidney disease at 12 and 24 months
Time frame: Month 12 and Month 24
Questionnaire for the assessment of practice staffs' confidence in managing type-2 diabetes and cholesterol at 12 and 24 month
Time frame: Month 12 and Month 24
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 8 Jan 2025.
- Background: PubMed 36578024Praetorius T, Baymler Lundberg AS, Sondergaard E, Tang Knudsen S, Sandbaek A. The effect of virtual specialist conferences between endocrinologists and general practitioners about type 2 diabetes: study protocol for a pragmatic randomized superiority trial. Trials. 2022 Dec 28;23(1):1059. doi: 10.1186/s13063-022-06961-y.
- Derived from this study: PubMed 40148532Praetorius T, Baymler Lundberg AS, Klausen Fredslund E, Blach Rossen N, Gregersen S, Prior A, Sondergaard E, Tang Knudsen S, Sandbaek A. Effect of video conferencing between primary and secondary care specialists on type 2 diabetes medication. NPJ Digit Med. 2025 Mar 28;8(1):179. doi: 10.1038/s41746-025-01570-w.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: No. Restrictions apply to the availability of these datasets. Register data will be used under license for the current study. Survey data and patient outcomes data are not publicly available as per the written consent signed by general practitioners and endocrinologists. Data are, however, available for research purposes from the authors upon reasonable request and with permission from study participants.
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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.
Thim Prætorius, PhD principal investigator
Aarhus University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Virtual specialist conferences in people with Diabetes Mellitus, Type 2, 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 3 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 8 Jan 2025. 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?
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?
Ischemic heart disease and/or stroke treated with GLP1-RA and SGLT2 inhibitor (time frame: Month 12). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05268081, which also lists 2 linked publications.
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 8 Jan 2025.