Type 2 DiabetesCVRiDNCT05948969
Transform CV Risk in Diabetes
A study testing Decision support and Facilitated referral to a cardiometabolic team-based center in people with Type 2 Diabetes, run by American College of Cardiology at 1 site in United States.
Trial summary
This initiative supports a real-world study of practice and physician prescribing patterns and a quality improvement initiative evaluating best practices (including clinical decision support, facilitated referral to cardiometabolic team-based care model, and general educational tools/resources) to im-prove use of… 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?
- Decision support and Facilitated referral to a cardiometabolic team-based center
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 750 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Sep 2023to 31 Dec 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- T2D diagnosis in the medical record
- ASCVD, defined as follows:
- Known Coronary artery disease (CAD), prior Acute coronary syndrome (ACS), or coronary artery revascularization
- Prior TIA/ischemic stroke or known carotid or intracerebral atherosclerosis, or prior carotid revascularization
- Prior Peripheral artery disease (PAD) including symptomatic claudication or pe-ripheral revascularization
Who cannot join
- Current participation in an interventional clinical assessment of an investigational drug/device (excluding assessments related to COVID-19)
- Currently receiving any SGLT2i or GLP-1RA
- Known allergy/hypersensitivity/intolerance/contraindication to SGLT2i or GLP-1RA
- Currently receiving comfort care or enrolled in hospice
- Life expectancy <1 year
- History of or plan for heart transplantation or ventricular assist device
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- Current or planned hemodialysis
- Decompensated end stage liver disease
- History of Fournier's Gangrene
- Type 1 diabetes
- Prior history of diabetic ketoacidosis
- Pregnancy or active breastfeeding
- History of Pancreatitis or pancreatic cancer
- History of medullary thyroid carcinoma or multiple endocrine neoplasia syndrome type 2 (MEN-2)
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Multiple sites nationwide
Washington D.C., District of Columbia, 20004
Shilpa Patel, SPatel@acc.org
About this study
This initiative supports a real-world study of practice and physician prescribing patterns and a quality improvement initiative evaluating best practices (including clinical decision support, facilitated referral to cardiometabolic team-based care model, and general educational tools/resources) to im-prove use of guideline-directed therapeutics known to lower cardiovascular risk (CV) in patients with type 2 diabetes (T2D).
- Conditions
- Type 2 Diabetes
- Being tested
- Decision support, Facilitated referral to a cardiometabolic team-based center
- 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.
Decision supportOther
This implementation strategy will include the clinician education of the previous arm and apply "audit and feedback" of prior care to inform recommendations for future care. These suggestions will encompass 5 different domains based on eligibility and potential opportunity for an SGLT2i, GLP-1RA, angiotensin converting enzyme inhibitors (ACEi)/angiotensin-receptor blockers (ARB), antiplatelet or antithrombotic therapy, and statin therapy. The incorporation of clinical decision support technology will be utilized to identify tailored opportunities for each CV risk reduction based on guideline recommendations for individual patients. Clinicians will be presented prompts with patient-specific recommendation(s) for further optimization of cardioprotective agents. These prompts will be conveyed by a Study Coordinator to responsible clinicians. The follow-up clinical prompts will be based on auditing of updated clinical parameters and medication use.
Facilitated referral to a cardiometabolic team-based centerOther
Each site will have access to clinicians caring for patients in structured, multidisciplinary cardiometabolic centers. Clinicians caring for patients randomized to this intervention strategy will receive a facilitated referral via the EHR together). If the clinician approves the referral, the patient will be referred to this local team-based comprehensive risk factor management clinic. All patients randomized to this group will be considered in this group whether or not a visit to the cardiometabolic center is completed.
| Study group | Role | What they receive |
|---|---|---|
| Education alone | No intervention | Not described |
| Education + decision support to provide suggestions for care optimization | Active comparator | Not described Receives: Other: Decision support |
| Education + facilitated referral to cardiometabolic team-based center for care optimization | Active comparator | Not described Receives: Other: Facilitated referral to a cardiometabolic team-based center |
What is being measured
The primary outcome is the main question the study is designed to answer.
New prescription of a SGLT2i and/or GLP-1RA
Proportion of treatment-naïve patients who are newly prescribed a SGLT2i and/or GLP-1RA over 9 months in the facilitated referral group (Arm C) versus usual care group (Arm A)
Measured: 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2023
- Study start1 Sep 2023 (estimated)
- Primary completion1 Jul 2024 (estimated)
- Study completion31 Dec 2024 (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.
- 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
- Masking
- None (open label)
- Enrolment
- 750 participants (estimated)
Sponsor and investigators
- Lead sponsor
- American College of Cardiology
- Sponsor type
- University, hospital or other
- Collaborators
- Novo Nordisk A/S
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05948969
- Sponsor's protocol ID
- Pro00059648
- Acronym
- CVRiD
- Status last verified
- Jul 2023
- First submitted
- 6 Jul 2023
- Last updated
- 17 Jul 2023
- 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 17 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transform CV Risk in Diabetes
- ClinicalTrials.gov ID
- NCT05948969
- Acronym / sponsor ID
- CVRiD / Pro00059648
- Conditions
- Type 2 Diabetes
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 750 participants (estimated)
- Lead sponsor
- American College of CardiologyUniversity, hospital or other
- Collaborators
- Novo Nordisk A/S
- Study start
- 1 Sep 2023 (estimated)
- Primary completion
- 1 Jul 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 17 Jul 2023 (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.
This initiative supports a real-world study of practice and physician prescribing patterns and a quality improvement initiative evaluating best practices (including clinical decision support, facilitated referral to cardiometabolic team-based care model, and general educational tools/resources) to im-prove use of guideline-directed therapeutics known to lower cardiovascular risk (CV) in patients with type 2 diabetes (T2D).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Education alone | No intervention | – |
| Education + decision support to provide suggestions for care optimization | Active comparator | Other: Decision support |
| Education + facilitated referral to cardiometabolic team-based center for care optimization | Active comparator | Other: Facilitated referral to a cardiometabolic team-based center |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- T2D diagnosis in the medical record
- ASCVD, defined as follows:
Key exclusion criteria (14 listed)
- Current participation in an interventional clinical assessment of an investigational drug/device (excluding assessments related to COVID-19)
- Currently receiving any SGLT2i or GLP-1RA
- Known allergy/hypersensitivity/intolerance/contraindication to SGLT2i or GLP-1RA
- Currently receiving comfort care or enrolled in hospice
- Life expectancy <1 year
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 |
|---|---|---|
| Decision supportThis implementation strategy will include the clinician education of the previous arm and apply "audit and feedback" of prior care to inform recommendations for future care. These suggestions will encompass 5 different domains based on eligibility and potential opportunity for an SGLT2i, GLP-1RA, angiotensin converting enzyme inhibitors (ACEi)/angiotensin-receptor blockers (ARB), antiplatelet or antithrombotic therapy, and statin therapy. The incorporation of clinical decision support technology will be utilized to identify tailored opportunities for each CV risk reduction based on guideline recommendations for individual patients. Clinicians will be presented prompts with patient-specific recommendation(s) for further optimization of cardioprotective agents. These prompts will be conveyed by a Study Coordinator to responsible clinicians. The follow-up clinical prompts will be based on auditing of updated clinical parameters and medication use. | Other | Education + decision support to provide suggestions for care optimization |
| Facilitated referral to a cardiometabolic team-based centerEach site will have access to clinicians caring for patients in structured, multidisciplinary cardiometabolic centers. Clinicians caring for patients randomized to this intervention strategy will receive a facilitated referral via the EHR together). If the clinician approves the referral, the patient will be referred to this local team-based comprehensive risk factor management clinic. All patients randomized to this group will be considered in this group whether or not a visit to the cardiometabolic center is completed. | Other | Education + facilitated referral to cardiometabolic team-based center for care optimization |
Primary outcome
New prescription of a SGLT2i and/or GLP-1RA
Time frame: 9 months
Proportion of treatment-naïve patients who are newly prescribed a SGLT2i and/or GLP-1RA over 9 months in the facilitated referral group (Arm C) versus usual care group (Arm A)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jul 2023.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Decision support and Facilitated referral to a cardiometabolic team-based center in people with Type 2 Diabetes, run by American College of Cardiology at 1 site in United States.
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 5 inclusion and 14 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: status not confirmed, as of the sponsor's last update on 17 Jul 2023. 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 United States. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Shilpa Patel (2023756354, SPatel@acc.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
New prescription of a SGLT2i and/or GLP-1RA (time frame: 9 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 17 Jul 2023; AzTrials last refreshed its copy on 27 Oct 2026.