NCT05268081

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
25

participants targeted

Target at below P25 for not_applicable diabetes-mellitus-type-2

Timeline
Completed

Started Jan 2022

Typical duration for not_applicable diabetes-mellitus-type-2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2022

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

January 31, 2022

Completed
1 month until next milestone

First Posted

Study publicly available on registry

March 7, 2022

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 30, 2023

Completed
1.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2024

Completed
Last Updated

January 8, 2025

Status Verified

December 1, 2024

Enrollment Period

1.7 years

First QC Date

January 31, 2022

Last Update Submit

January 6, 2025

Conditions

Diabetes Mellitus, Type 2

Keywords

Specialist conferencesVirtual conferencesFamily physicianEndocrinologistType 2-diabetesRandomized Controlled Trial

Outcome Measures

Primary Outcomes (9)

  • 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

    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)

    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

    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.

    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.

    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.

    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.

    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.

    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.

    Month 12

Secondary Outcomes (26)

  • Ischemic heart disease and/or stroke treated with GLP1-RA and SGLT2 inhibitor

    Month 24

  • Micro/macro-albuminuria treated with ACE-inhibitor or AT2

    Month 24

  • LDL>2.5 mmol/L treated with Statins

    Month 24

  • Questionnaire for the assessment of general practitioners' confidence in managing type-2 diabetes in general at 24 month

    Month 24

  • Questionnaire for the assessment of general practitioners' skills in managing type-2 diabetes in general at 24 month

    Month 24

  • +21 more secondary outcomes

Study Arms (2)

Virtual specialist conferences

EXPERIMENTAL

The group of general practices who participates in the virtual specialist conferences with endocrinologists.

Other: Virtual specialist conferences

Standard of care

NO INTERVENTION

Receives the usual, standard practice.

Interventions

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).

Virtual specialist conferences

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Steno Diabetes Center Aarhus

Aarhus N, Danmark, 8200, Denmark

Location

Related Publications (2)

  • 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.

    PMID: 36578024BACKGROUND

  • Praetorius 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.

    PMID: 40148532DERIVED

Related Links

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Officials

  • Thim Prætorius, PhD

    Aarhus University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
Masking description of intervention status, i.e., outcomes assessor will not know who received the intervention.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Pragmatic randomized controlled trial
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 31, 2022

First Posted

March 7, 2022

Study Start

January 1, 2022

Primary Completion

August 30, 2023

Study Completion

September 30, 2024

Last Updated

January 8, 2025

Record last verified: 2024-12

Data Sharing

IPD Sharing
Will not share

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.

Locations

DK(1)